As reported to Jess Ebert, CIS Compliance Specialist
On the eleventh day of CIS, the blog introduced to me…
Founding Partner and VP of Operations, Jim Collins
(and Joe Calarco, Annette Horner, Kimberly Gilbert, Dana Zelig, Beth Kline, Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)
Q: What’s your background?
A: I was born in Brooklyn, NY and moved to South Jersey at age 5 when my father, who was a stock broker on Wall Street, took a job with a small start up firm on the Philadelphia Stock Exchange. I went to Rider College and majored in Accounting and Finance. I received my CPA in 1990 and quickly got out of accounting. I worked for Barnett International, a division of PAREXEL Consulting, as VP of Operations for 14 years prior to co-founding CIS in 2004.
Q: Why did you decide to start CIS?
A: After 14 years of a being part of a large public company and spending the majority of my time on internal politics and BS - I thought it would be a refreshing change to build a company where the culture is based on performance, growing professionally and financially, and helping clients.
Q: What company milestones are you proud of?
A: Our goal in year 1 was to be in business in year 2, so that is a milestone I am very proud of. Now that we are approaching our 5 year anniversary as a company, I am proud to be working with close to 50 of the smartest, most hard working and talented staff in our industry.
Q: If you could give your employees once piece of advice, what would it be?
A: You get out of your career what you put into it– there are no short cuts. By taking it easy you limit your own growth – professionally and financially.
Q: What’s your favorite holiday movie and why?
A: Elf – Buddy is the best!
Q: What are you most thankful for this holiday season?
A: The ability to get up every day and see that I have a healthy family, and I know I have the ability to be in control of my own destiny.
Email Jim any time at jimcollins@cis-partners.com!
There are 4 days until the New Year!
Monday, December 28, 2009
Wednesday, December 23, 2009
On the Tenth Day of CIS...
As reported to Jess Ebert, CIS Compliance Specialist
On the tenth day of CIS, the blog introduced to me…
Senior Compliance Manager, Joseph Calarco
(and Annette Horner, Kimberly Gilbert, Dana Zelig, Beth Kline, Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)
Q: What’s your background?
A: I started my career at the University of Pennsylvania’s Treatment Research Center as a site coordinator supporting clinical trials on anabolic steroid use and alcohol dependence. After a short stint as a Data Coordinator at Scirex (small CRO), I entered a full-time Clinical Social Work Graduate Program at Bryn Mawr College. I worked part-time at Aventis Behring during Social Work school and worked there for two years full-time after graduating with my M.S. in Social Services.
In 2002, I joined Merck & Co, Inc. as a project leader in Global Clinical Data Operations. In this role I led Clinical Data Management teams that filed Infectious Disease and Oncology products. For more than four years I worked as a manager responsible for the External Data Services and Clinical Pharmacology departments. As a manager, I was responsible for managing Merck’s book of business and the staff resourced to support the projects in these departments. Additionally, I was charged with several process improvement projects, one of which allowed me to complete my Six Sigma Green Belt certification.
Q: What projects and product lines do you work with at CIS?
A: My primary project at CIS has been the Shire Standard Operating Procedures project. I am thankful for the opportunity to learn a lot about R&D and Commercial Compliance concerns in a short period of time.
Q: What do you like about CIS?
A: The people I get to work with and the company’s size. Team chemistry can be elusive at most jobs. I am fortunate that the people I interact with each day are open, knowledgeable and lead by example. More importantly, they play as hard as they work. Anyone who has been in any industry long enough knows that situations like this are the exception and not the norm.
CIS’ size also means there are an abundance of opportunities to contribute to and succeed. Large corporations often struggle to make employees feel like their contributions matter.
Q: What are you most thankful for this holiday season?
A: My family’s good health and my friends.
Q: What is your favorite holiday cookie or food?
A: My mother-in-law’s French Toast Casserole. It is basically French Toast covered maple syrup and brown sugar. How can you go wrong?
Q: What is your favorite holiday song?
A: I have two favourite holiday songs. The U2 version of “Christmas (Baby Please Come Home)” and The Bare Naked Ladies version of “Auld Lang Syne”.
Email Joe any time at joecalarco@cis-partners.com!
Currently there are:
2 days until Christmas,
and 3 days until Kwanzaa!
The days are getting longer!
On the tenth day of CIS, the blog introduced to me…
Senior Compliance Manager, Joseph Calarco
(and Annette Horner, Kimberly Gilbert, Dana Zelig, Beth Kline, Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)
Q: What’s your background?
A: I started my career at the University of Pennsylvania’s Treatment Research Center as a site coordinator supporting clinical trials on anabolic steroid use and alcohol dependence. After a short stint as a Data Coordinator at Scirex (small CRO), I entered a full-time Clinical Social Work Graduate Program at Bryn Mawr College. I worked part-time at Aventis Behring during Social Work school and worked there for two years full-time after graduating with my M.S. in Social Services.
In 2002, I joined Merck & Co, Inc. as a project leader in Global Clinical Data Operations. In this role I led Clinical Data Management teams that filed Infectious Disease and Oncology products. For more than four years I worked as a manager responsible for the External Data Services and Clinical Pharmacology departments. As a manager, I was responsible for managing Merck’s book of business and the staff resourced to support the projects in these departments. Additionally, I was charged with several process improvement projects, one of which allowed me to complete my Six Sigma Green Belt certification.
Q: What projects and product lines do you work with at CIS?
A: My primary project at CIS has been the Shire Standard Operating Procedures project. I am thankful for the opportunity to learn a lot about R&D and Commercial Compliance concerns in a short period of time.
Q: What do you like about CIS?
A: The people I get to work with and the company’s size. Team chemistry can be elusive at most jobs. I am fortunate that the people I interact with each day are open, knowledgeable and lead by example. More importantly, they play as hard as they work. Anyone who has been in any industry long enough knows that situations like this are the exception and not the norm.
CIS’ size also means there are an abundance of opportunities to contribute to and succeed. Large corporations often struggle to make employees feel like their contributions matter.
Q: What are you most thankful for this holiday season?
A: My family’s good health and my friends.
Q: What is your favorite holiday cookie or food?
A: My mother-in-law’s French Toast Casserole. It is basically French Toast covered maple syrup and brown sugar. How can you go wrong?
Q: What is your favorite holiday song?
A: I have two favourite holiday songs. The U2 version of “Christmas (Baby Please Come Home)” and The Bare Naked Ladies version of “Auld Lang Syne”.
Email Joe any time at joecalarco@cis-partners.com!
Currently there are:
2 days until Christmas,
and 3 days until Kwanzaa!
The days are getting longer!
Articles of the Week!
Courtesy of: Kerri McCutchin, CIS Compliance Associate
kerrimccutchin@cis-partners.com
1) Senate moves health bill forward
http://www.cnn.com/2009/POLITICS/12/22/health.care.senate.vote/index.html
2) Obesity, Inactivity Keeping Heart Health Stats Down
http://news.yahoo.com/s/hsn/20091218/hl_hsn/obesityinactivitykeepinghearthealthstatsdown
3) Drug Maker Sanofi-Aventis Buys Chattem for $1.9 Billion
http://www.nytimes.com/2009/12/22/business/global/22drug.html?_r=1&adxnnl=1&ref=health&adxnnlx=1261497699-LLjRGlc6Be/Ntgc/K0065w
4) Cosmetic Surgeons Get Reid to Tax Tanning Salons Instead
http://online.wsj.com/article/SB126144830913601141.html
5) COBRA Help For Laid-Off Workers May Come Before Christmas
http://www.kaiserhealthnews.org/Stories/2009/December/17/cobra-extension.aspx
kerrimccutchin@cis-partners.com
1) Senate moves health bill forward
http://www.cnn.com/2009/POLITICS/12/22/health.care.senate.vote/index.html
2) Obesity, Inactivity Keeping Heart Health Stats Down
http://news.yahoo.com/s/hsn/20091218/hl_hsn/obesityinactivitykeepinghearthealthstatsdown
3) Drug Maker Sanofi-Aventis Buys Chattem for $1.9 Billion
http://www.nytimes.com/2009/12/22/business/global/22drug.html?_r=1&adxnnl=1&ref=health&adxnnlx=1261497699-LLjRGlc6Be/Ntgc/K0065w
4) Cosmetic Surgeons Get Reid to Tax Tanning Salons Instead
http://online.wsj.com/article/SB126144830913601141.html
5) COBRA Help For Laid-Off Workers May Come Before Christmas
http://www.kaiserhealthnews.org/Stories/2009/December/17/cobra-extension.aspx
Tuesday, December 22, 2009
All I Want For Christmas Is….Healthcare Reform?
By: Jordan Mummau, CIS Compliance Associate
jordanmummau@cis-partners.com
One giant leap for lawmakers, an even bigger leap for healthcare. In the waning hours of Sunday night, and into 1:00am Monday morning on December 21st, the U.S. Senate voted to end debate on the health reform bill. This vote will propel the legislation to a final vote on Christmas Eve. [1]
If this bill is passed and aligned with the one passed by the House of Representatives, 30 million uninsured Americans will be opening the gift of insurance this Christmas. However, some Republicans may argue that this bill is no gift at all, but rather will prove to be a detrimental and counterproductive mistake. Arizona Senator John McCain was quoted as saying “We must look back and say, we did everything we can to prevent this terrible mistake from taking place”.[1] As you may have guessed, both the Democratic and Republican parties tended to support party norms on this vote, with all 58 Democrats, and the Senate’s two Independents, voting in favor of the bill against unanimous Republican opposition. The vote, 60-40, was considered by both sides to be monumental.
The actual legislation aims at providing health benefits to more than 30 million people who are currently uninsured. The bill would require all Americans to pay financial penalties for failing to obtain health insurance and would provide federal subsidies to help moderate- to low-income families buy private coverage.[2] These services would be made possible by the highly criticized complex array of taxes that would yield a tax hike for individuals earning more than $200,000 and couples earning more than $250,000.[3]
Supporters of the Bill claim that its $871 billion price tag will actually assist the U.S. Government in reducing the federal budget deficit by $132 billion through new revenues and cuts in spending. However, Republicans are more apprehensive about the severe expense of the bill, charging Democrats with recklessly rushing to adopt the proposed 2,700 page bill that would reshape one sixth (1/6) of the nation’s economy.[4]
Inherent in all reforms are potential benefits and risks, and this legislation is without exception. While it may be difficult for one party to see the other’s point of view, it is certainly easy for both parties to recognize the sheer magnitude of this decision. As citizens of this country, we can only hope that the people we have elected to make these decisions do so in a way that will allow this great nation to prosper. Happy Holidays and God Bless America!
Sources:
[1] http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20091221/health_overhaul_091221/20091221?hub=
[2] http://www.nytimes.com/2009/12/21/us/21vote.html?pagewanted=1&_r=1&hp
[3] http://www.thaindian.com/newsportal/health1/senate-passes-health-care-reform-bill-in-cloture-vote_100292777.html
[4] http://www.nytimes.com/2009/12/21/us/21vote.html?pagewanted=1&_r=1&hp
jordanmummau@cis-partners.com
One giant leap for lawmakers, an even bigger leap for healthcare. In the waning hours of Sunday night, and into 1:00am Monday morning on December 21st, the U.S. Senate voted to end debate on the health reform bill. This vote will propel the legislation to a final vote on Christmas Eve. [1]
If this bill is passed and aligned with the one passed by the House of Representatives, 30 million uninsured Americans will be opening the gift of insurance this Christmas. However, some Republicans may argue that this bill is no gift at all, but rather will prove to be a detrimental and counterproductive mistake. Arizona Senator John McCain was quoted as saying “We must look back and say, we did everything we can to prevent this terrible mistake from taking place”.[1] As you may have guessed, both the Democratic and Republican parties tended to support party norms on this vote, with all 58 Democrats, and the Senate’s two Independents, voting in favor of the bill against unanimous Republican opposition. The vote, 60-40, was considered by both sides to be monumental.
The actual legislation aims at providing health benefits to more than 30 million people who are currently uninsured. The bill would require all Americans to pay financial penalties for failing to obtain health insurance and would provide federal subsidies to help moderate- to low-income families buy private coverage.[2] These services would be made possible by the highly criticized complex array of taxes that would yield a tax hike for individuals earning more than $200,000 and couples earning more than $250,000.[3]
Supporters of the Bill claim that its $871 billion price tag will actually assist the U.S. Government in reducing the federal budget deficit by $132 billion through new revenues and cuts in spending. However, Republicans are more apprehensive about the severe expense of the bill, charging Democrats with recklessly rushing to adopt the proposed 2,700 page bill that would reshape one sixth (1/6) of the nation’s economy.[4]
Inherent in all reforms are potential benefits and risks, and this legislation is without exception. While it may be difficult for one party to see the other’s point of view, it is certainly easy for both parties to recognize the sheer magnitude of this decision. As citizens of this country, we can only hope that the people we have elected to make these decisions do so in a way that will allow this great nation to prosper. Happy Holidays and God Bless America!
Sources:
[1] http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20091221/health_overhaul_091221/20091221?hub=
[2] http://www.nytimes.com/2009/12/21/us/21vote.html?pagewanted=1&_r=1&hp
[3] http://www.thaindian.com/newsportal/health1/senate-passes-health-care-reform-bill-in-cloture-vote_100292777.html
[4] http://www.nytimes.com/2009/12/21/us/21vote.html?pagewanted=1&_r=1&hp
On the Ninth Day of CIS...
As reported to Jess Ebert, CIS Compliance Specialist
On the ninth day of CIS, the blog introduced to me…
CIS Senior Director, Clinical Consulting Services, Annette Horner
(and Kimberly Gilbert, Dana Zelig, Beth Kline, Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)
Q: What’s your background?
A: For the past 15 years, I’ve worked as a consultant to global pharmaceutical and medical device companies to develop and implement clinical and regulatory processes resulting from large-scale clinical/regulatory re-engineering or compliance risk mitigation projects. For five years before that, my consulting work focused on developing clinical and regulatory training programs for a variety of pharmaceutical clinical research clients. Earlier in my professional life I taught literature and writing in high schools and colleges. When I decided I wanted to understand more about how organizations work, I pursued a PhD at Temple University in Organizational Design, thinking I would work in a college or university setting. By the time I finished the PhD work, I had a network of business consulting friends and entered the world of pharmaceutical consulting in that way.
Q: What projects and product lines do you work with at CIS?
A: I work on clinical compliance client projects. I’m involved in client meetings and in developing client proposals for clinical compliance services. I also work on the upfront design and planning for a new client project, and provide direct client service on SOP projects that involve creating a compliance framework. I also designed and helped implement the Clinical PCX.
Q: What do you like about CIS?
A: I had worked in another company with the CIS owners, so I was first attracted to CIS by that prior experience with the owners, both of whom I admire for their business acumen and ethics, as well as their emphasis on transferring authority to others in the company. I also like the CIS business model, especially the clear focus on providing compliance services across a single complex industry, and the fact that CIS is still strongly an entrepreneurial company which means it will attract capable and flexible staff who want to grow with the company. That’s good for CIS and for clients as well.
Q: What are you looking forward to this holiday season?
A: This has been a year of transition for me. My husband and I moved from Ohio to North Carolina last February. Now we are much closer to family and long-time friends, so I’m looking forward to spending time with my special people and maybe doing a little wintertime gardening.
Email Annette any time at annettehorner@cis-partners.com!
Currently there are:
3 days until Christmas,
and 4 days until Kwanzaa!
The days are getting longer!
On the ninth day of CIS, the blog introduced to me…
CIS Senior Director, Clinical Consulting Services, Annette Horner
(and Kimberly Gilbert, Dana Zelig, Beth Kline, Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)
Q: What’s your background?
A: For the past 15 years, I’ve worked as a consultant to global pharmaceutical and medical device companies to develop and implement clinical and regulatory processes resulting from large-scale clinical/regulatory re-engineering or compliance risk mitigation projects. For five years before that, my consulting work focused on developing clinical and regulatory training programs for a variety of pharmaceutical clinical research clients. Earlier in my professional life I taught literature and writing in high schools and colleges. When I decided I wanted to understand more about how organizations work, I pursued a PhD at Temple University in Organizational Design, thinking I would work in a college or university setting. By the time I finished the PhD work, I had a network of business consulting friends and entered the world of pharmaceutical consulting in that way.
Q: What projects and product lines do you work with at CIS?
A: I work on clinical compliance client projects. I’m involved in client meetings and in developing client proposals for clinical compliance services. I also work on the upfront design and planning for a new client project, and provide direct client service on SOP projects that involve creating a compliance framework. I also designed and helped implement the Clinical PCX.
Q: What do you like about CIS?
A: I had worked in another company with the CIS owners, so I was first attracted to CIS by that prior experience with the owners, both of whom I admire for their business acumen and ethics, as well as their emphasis on transferring authority to others in the company. I also like the CIS business model, especially the clear focus on providing compliance services across a single complex industry, and the fact that CIS is still strongly an entrepreneurial company which means it will attract capable and flexible staff who want to grow with the company. That’s good for CIS and for clients as well.
Q: What are you looking forward to this holiday season?
A: This has been a year of transition for me. My husband and I moved from Ohio to North Carolina last February. Now we are much closer to family and long-time friends, so I’m looking forward to spending time with my special people and maybe doing a little wintertime gardening.
Email Annette any time at annettehorner@cis-partners.com!
Currently there are:
3 days until Christmas,
and 4 days until Kwanzaa!
The days are getting longer!
On the Eighth Day of CIS...
As reported to Jess Ebert, Compliance Specialist
On the eighth day of CIS, the blog introduced to me…
Compliance Manager, Kimberly Gilbert
(and Dana Zelig, Beth Kline, Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)
Q: What’s your background?
A: I am a registered nurse with eleven years of clinical research experience in various capacities across the pharmaceutical industry including roles at the sponsor level, the investigative site, and contract research organizations (CROs). Most of my previous experience in the clinical research arena consists of managing clinical trials across all phases of the drug development cycle in a clinical role.
Q: What projects and product lines do you work with at CIS?
A: I currently work on the clinical product lines at CIS.
Q: Why did you decide to join CIS?
A: I decided to join CIS for two reasons; I wanted to work for a company where I felt valued as an employee and I was also looking for variety in my career. I have found both of these qualities at CIS. I finally feel like I am part of an organization where my ideas and opinions are valued as well as appreciated, and for that I am truly thankful. I also feel like variety is the spice of life, and here at CIS I never have the same day twice! I am able to utilize my previous experience in the pharmaceutical industry in so many different directions at CIS and that makes for interesting days!
Q: What are you looking forward to this holiday season?
A: Having some time off to relax and enjoy the wonders of the season with family and friends! OH and PRESENTS!
Email Kimberly any time at kimberlygilbert@cis-partners.com!
Currently there are:
3 days until Christmas,
and 4 days until Kwanzaa!
The days are now getting longer!
On the eighth day of CIS, the blog introduced to me…
Compliance Manager, Kimberly Gilbert
(and Dana Zelig, Beth Kline, Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)
Q: What’s your background?
A: I am a registered nurse with eleven years of clinical research experience in various capacities across the pharmaceutical industry including roles at the sponsor level, the investigative site, and contract research organizations (CROs). Most of my previous experience in the clinical research arena consists of managing clinical trials across all phases of the drug development cycle in a clinical role.
Q: What projects and product lines do you work with at CIS?
A: I currently work on the clinical product lines at CIS.
Q: Why did you decide to join CIS?
A: I decided to join CIS for two reasons; I wanted to work for a company where I felt valued as an employee and I was also looking for variety in my career. I have found both of these qualities at CIS. I finally feel like I am part of an organization where my ideas and opinions are valued as well as appreciated, and for that I am truly thankful. I also feel like variety is the spice of life, and here at CIS I never have the same day twice! I am able to utilize my previous experience in the pharmaceutical industry in so many different directions at CIS and that makes for interesting days!
Q: What are you looking forward to this holiday season?
A: Having some time off to relax and enjoy the wonders of the season with family and friends! OH and PRESENTS!
Email Kimberly any time at kimberlygilbert@cis-partners.com!
Currently there are:
3 days until Christmas,
and 4 days until Kwanzaa!
The days are now getting longer!
Monday, December 21, 2009
On the Seventh Day of CIS...
As reported to Jess Ebert, Compliance Specialist
On the seventh day of CIS, the blog introduced to me…
PCX Product Manager, Dana Zelig
(and Beth Kline, Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)
Q: What’s your background?
A: Prior to joining CIS, I worked in Regulatory Affairs at a large pharma company, and in the Internal Audit department of a large bank. Both positions provided me with an appreciation of compliance that has served me well at CIS.
Q: What projects and product lines do you work with at CIS?
A: I am the PCX Product Manager the and co-editor of the Pharma Compliance Blog, which are great products, and great tools to stay up to date on regulations and current events in the pharma space. I also work with CIS’ GP SMEs performing audits, assessments, and calculations.
Q: Why did you decide to join CIS?
A: I decided to join CIS because it seemed totally different than the companies I came from. It is a company where hard work and a good attitude are always appreciated, which makes it a great place to be every day (or at least the days I’m not visiting clients).
Q: What’s the best gift you ever gave someone for the holidays?
A: What’s the best gift you ever received for the holidays? One year my grandmother took my whole family on a cruise for Christmas. That was definitely the best Christmas ever. We didn’t get each other big presents that year, but my brother and sister and I brought stockings for each other and filled them with crazy gifts. I got a pair of Santa boxers that I still wear all the time.
Q: What is your favorite holiday song?
A: I love Oh Holy Night. It always puts me in the holiday spirit!
Email Dana any time at danazelig@cis-partners.com!
Currently there are:
4 days until Christmas,
and 5 days until Kwanzaa!
Today is Winter Solstice!
On the seventh day of CIS, the blog introduced to me…
PCX Product Manager, Dana Zelig
(and Beth Kline, Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)
Q: What’s your background?
A: Prior to joining CIS, I worked in Regulatory Affairs at a large pharma company, and in the Internal Audit department of a large bank. Both positions provided me with an appreciation of compliance that has served me well at CIS.
Q: What projects and product lines do you work with at CIS?
A: I am the PCX Product Manager the and co-editor of the Pharma Compliance Blog, which are great products, and great tools to stay up to date on regulations and current events in the pharma space. I also work with CIS’ GP SMEs performing audits, assessments, and calculations.
Q: Why did you decide to join CIS?
A: I decided to join CIS because it seemed totally different than the companies I came from. It is a company where hard work and a good attitude are always appreciated, which makes it a great place to be every day (or at least the days I’m not visiting clients).
Q: What’s the best gift you ever gave someone for the holidays?
A: What’s the best gift you ever received for the holidays? One year my grandmother took my whole family on a cruise for Christmas. That was definitely the best Christmas ever. We didn’t get each other big presents that year, but my brother and sister and I brought stockings for each other and filled them with crazy gifts. I got a pair of Santa boxers that I still wear all the time.
Q: What is your favorite holiday song?
A: I love Oh Holy Night. It always puts me in the holiday spirit!
Email Dana any time at danazelig@cis-partners.com!
Currently there are:
4 days until Christmas,
and 5 days until Kwanzaa!
Today is Winter Solstice!
Friday, December 18, 2009
On the Sixth Day of CIS...
As reported to Jess Ebert, Compliance Specialist
On the sixth day of CIS, the blog introduced to me…
Compliance Manager, Beth Kline
(and Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)
Q: What’s your background?
A: I have a BA in Organizational Management and a MA in Teaching. I have worked in pharmaceutical consulting for over 12 years and taught English in China for two years.
Q: What projects and product lines do you work with at CIS?
A: I work in clinical and manufacturing. I am also the subject matter expert for the Clinical PCX.
Q: What do you like about CIS?
A: I like that it is a small company where you can be actively involved in all aspects of the business. I like the variety of work they do and never knowing what tomorrow might bring!
Q: Why did you decide to join CIS?
A: I wanted to get back into consulting and joining CIS provided that opportunity.
Q: What CIS accomplishments are you most proud of this year?
A: Hiring me? HAHA! Kidding – expanding into manufacturing and all of that business they are acquiring…excellent!
Q: What are you looking forward to this holiday season?
A: Having almost two weeks off. Living in New York and driving six hours roundtrip every weekend to and from home has been a bit tough on my family life, so having some extended time at home will be very welcome at this time of year.
Q: What’s your favorite holiday movie?
A: My favorite holiday movie is White Christmas.
Q: What's your favorite holiday tradition?
A: Eating cookies!
Q: What are you most thankful for this holiday season?
A: My job and an understanding and patient husband.
Q: What is your favorite holiday cookie or food?
A: I love them all!!!
Q: What is your favorite holiday song?
A: Joy to the World
Email Beth any time at bethkline@cis-partners.com!
Currently there are:
7 days until Christmas,
8 days until Kwanzaa,
and 3 days until Winter Solstice!
Tonight is the 8th night of Chanukah!
On the sixth day of CIS, the blog introduced to me…
Compliance Manager, Beth Kline
(and Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)
Q: What’s your background?
A: I have a BA in Organizational Management and a MA in Teaching. I have worked in pharmaceutical consulting for over 12 years and taught English in China for two years.
Q: What projects and product lines do you work with at CIS?
A: I work in clinical and manufacturing. I am also the subject matter expert for the Clinical PCX.
Q: What do you like about CIS?
A: I like that it is a small company where you can be actively involved in all aspects of the business. I like the variety of work they do and never knowing what tomorrow might bring!
Q: Why did you decide to join CIS?
A: I wanted to get back into consulting and joining CIS provided that opportunity.
Q: What CIS accomplishments are you most proud of this year?
A: Hiring me? HAHA! Kidding – expanding into manufacturing and all of that business they are acquiring…excellent!
Q: What are you looking forward to this holiday season?
A: Having almost two weeks off. Living in New York and driving six hours roundtrip every weekend to and from home has been a bit tough on my family life, so having some extended time at home will be very welcome at this time of year.
Q: What’s your favorite holiday movie?
A: My favorite holiday movie is White Christmas.
Q: What's your favorite holiday tradition?
A: Eating cookies!
Q: What are you most thankful for this holiday season?
A: My job and an understanding and patient husband.
Q: What is your favorite holiday cookie or food?
A: I love them all!!!
Q: What is your favorite holiday song?
A: Joy to the World
Email Beth any time at bethkline@cis-partners.com!
Currently there are:
7 days until Christmas,
8 days until Kwanzaa,
and 3 days until Winter Solstice!
Tonight is the 8th night of Chanukah!
Articles of the Week!
Courtesy of: Jess Ebert, CIS Compliance Specialist
jessicaebert@cis-partners.com
1) Amendment To Allow Drug Importation Fails In Senate
http://www.medicalnewstoday.com/articles/174295.php
2) Pharma Faces More Scrutiny On Drug Prices
http://www.fiercepharma.com/story/pharma-faces-scrutiny-drug-prices/2009-12-08
3) Senators: Drug Makers Will Pay More For Health Bill
http://www.drugs.com/news/senators-makers-pay-more-health-bill-21563.html
4) Democrats Drop Plan to Expand Medicare
http://online.wsj.com/article/SB126083637029991305.html
5) WHO Wants Health Issues at Heart of Climate Talks
http://www.cnn.com/2009/HEALTH/12/17/climate.change.health/index.html
jessicaebert@cis-partners.com
1) Amendment To Allow Drug Importation Fails In Senate
http://www.medicalnewstoday.com/articles/174295.php
2) Pharma Faces More Scrutiny On Drug Prices
http://www.fiercepharma.com/story/pharma-faces-scrutiny-drug-prices/2009-12-08
3) Senators: Drug Makers Will Pay More For Health Bill
http://www.drugs.com/news/senators-makers-pay-more-health-bill-21563.html
4) Democrats Drop Plan to Expand Medicare
http://online.wsj.com/article/SB126083637029991305.html
5) WHO Wants Health Issues at Heart of Climate Talks
http://www.cnn.com/2009/HEALTH/12/17/climate.change.health/index.html
Thursday, December 17, 2009
On the Fifth Day of CIS...
As reported to Jess Ebert, Compliance Specialist
On the fifth day of CIS, the blog introduced to me…
CIS Strategic Advisor, Government Affairs, Bill Baxter
(and Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)
Q: What’s your background?
A: I directed the Medicaid & State Rebate Programs for all the J&J operating companies for over 10 years. Prior to that I taught school for a couple of years before joining J&J as a sale rep, moving into sales training & management, and ultimately into government affairs.
Q: What projects and product lines do you work with at CIS?
A: My main focus is GP, working with Chris Cobourn, Clarissa Crain, Steven Moore and Sabrina Skari. My main product line would be the Pharma Compliance Exchange (PCX) and providing compliance guidance to various operating companies.
Q: What do you like about CIS?
A: The professionalism as well as the feel of a “small” (but successful and rapidly growing) company environment.
Q: Why did you decide to join CIS?
A: I liked the enthusiasm, talent and quality of the individuals here at CIS (AND, my wife was willing to pay Jim & Toni to hire me… )
Q: What CIS accomplishments are you most proud of this year?
A: As a member of the company, making the “100” listing. As an individual, I’m proud of obtaining access to a number of companies.
Q: What are you looking forward to this holiday season?
A: Spending time with our “boys”, singing the “Halleluiah Chorus” with the choir at Christmas services, and getting “Christmas Letters” from friends and family (and at the same time guessing what news is true and what are “stretched” family facts…)
Q: What’s your favorite holiday movie?
A: “Die Hard” (it takes place at Christmas doesn’t it?), and “A Christmas Story” (I always wanted a BB gun…)
Q: What's your favorite holiday tradition?
A: Opening presents on Christmas morning and watching the boys’ expressions. (I was frequently tempted to put the proverbial lumps of coal in their stockings…)
Q: What’s the best gift you ever gave someone for the holidays?
A: A cruise (but she had to take it with me…)
Q: What’s the best gift you ever received for the holidays?
A: Getting to go on the cruise I just mentioned.
Q: What are you most thankful for this holiday season?
A: That the family is safe, sound and healthy, and that the economy did not collapse as feared.
Q: What is your favorite holiday cookie or food?
A: Macadamia nut cookies and Christmas ham; does a nice Merlot count as holiday “food”?
Q: What is your favorite holiday song?
A: I have several, but if I have to pick one it’s probably “There’s no place like home for the holidays.”
Email Bill any time at billbaxter@cis-partners.com!
Currently there are:
8 days until Christmas,
9 days until Kwanzaa,
and 4 days until Winter Solstice!
Tonight is the 7th night of Chanukah!
On the fifth day of CIS, the blog introduced to me…
CIS Strategic Advisor, Government Affairs, Bill Baxter
(and Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)
Q: What’s your background?
A: I directed the Medicaid & State Rebate Programs for all the J&J operating companies for over 10 years. Prior to that I taught school for a couple of years before joining J&J as a sale rep, moving into sales training & management, and ultimately into government affairs.
Q: What projects and product lines do you work with at CIS?
A: My main focus is GP, working with Chris Cobourn, Clarissa Crain, Steven Moore and Sabrina Skari. My main product line would be the Pharma Compliance Exchange (PCX) and providing compliance guidance to various operating companies.
Q: What do you like about CIS?
A: The professionalism as well as the feel of a “small” (but successful and rapidly growing) company environment.
Q: Why did you decide to join CIS?
A: I liked the enthusiasm, talent and quality of the individuals here at CIS (AND, my wife was willing to pay Jim & Toni to hire me… )
Q: What CIS accomplishments are you most proud of this year?
A: As a member of the company, making the “100” listing. As an individual, I’m proud of obtaining access to a number of companies.
Q: What are you looking forward to this holiday season?
A: Spending time with our “boys”, singing the “Halleluiah Chorus” with the choir at Christmas services, and getting “Christmas Letters” from friends and family (and at the same time guessing what news is true and what are “stretched” family facts…)
Q: What’s your favorite holiday movie?
A: “Die Hard” (it takes place at Christmas doesn’t it?), and “A Christmas Story” (I always wanted a BB gun…)
Q: What's your favorite holiday tradition?
A: Opening presents on Christmas morning and watching the boys’ expressions. (I was frequently tempted to put the proverbial lumps of coal in their stockings…)
Q: What’s the best gift you ever gave someone for the holidays?
A: A cruise (but she had to take it with me…)
Q: What’s the best gift you ever received for the holidays?
A: Getting to go on the cruise I just mentioned.
Q: What are you most thankful for this holiday season?
A: That the family is safe, sound and healthy, and that the economy did not collapse as feared.
Q: What is your favorite holiday cookie or food?
A: Macadamia nut cookies and Christmas ham; does a nice Merlot count as holiday “food”?
Q: What is your favorite holiday song?
A: I have several, but if I have to pick one it’s probably “There’s no place like home for the holidays.”
Email Bill any time at billbaxter@cis-partners.com!
Currently there are:
8 days until Christmas,
9 days until Kwanzaa,
and 4 days until Winter Solstice!
Tonight is the 7th night of Chanukah!
Wednesday, December 16, 2009
Surprise Tricare Ruling Handed Down
By: Dave Rice, CIS Director of Federal Contracting
daverice@cis-partners.com
As many of you may have heard, the United States District Court for the District of Columbia recently ruled on the Tricare Retail Pharmacy Program (TRRx) issue in a decision that surprised many, including myself. Below is some basic background information on the issue as well as analysis of the ruling that was provided to us by Joy Sturm, Partner, Hogan & Hartson LLP.
Background
On January 28, 2008, Congress enacted the National Defense Authorization Act for Fiscal Year 2008 ("NDAA-08"). Section 703 of NDAA-08 requires that pharmaceuticals paid for by the Department of Defense ("Department" or "DoD") under its TRICARE retail pharmacy program be subject to pricing standards known as Federal Ceiling Prices. The Department promulgated a final rule implementing section 703 on March 17, 2009. Under this rule, pharmaceutical manufacturers cannot receive more than the Federal Ceiling Prices for pharmaceuticals purchased by DoD for the retail pharmacy program, and must refund amounts in excess of the Federal Ceiling Prices for prescriptions filled on or after January 28, 2008. The Coalition for Common Sense in Government Procurement ("Coalition") challenged the Department's rule, asserted that the rule should be set aside because, inter alia, the Department erroneously interpreted NDAA-08 to require refunds by manufacturers to DoD and to require the statute's obligations to apply beginning on January 28, 2008.
Analysis of Ruling
In a surprising decision, on December 7 the U.S. District Court for the District of Columbia ruled that while the Department of Defense (DoD) did not follow proper procedures in issuing its Tricare Retail Pharmacy (TRRx) Final Rule (74 Fed. Reg. 11,279 (Mar. 17, 2009)) implementing Section 703 of the National Defense Authorization Act for FY 2008, the statute "requires that Federal Ceiling Prices apply to all retail pharmacy program prescriptions filled on or after January 28, 2008."
While the court found for the Coalition on its procedural challenge to the Final Rule, it sided with DoD on the substantive issue presented in the case. The court held that because Section 703 did not mandate a rebate program, DoD had been required to exercise its discretion in requiring rebates from manufacturers under its Final Rule. The court therefore concluded that DoD's statements throughout the Final Rule that such a program was required "by operation of law" by Section 703 rendered the Final Rule procedurally defective.
The court held that remand of the Final Rule was necessary so that the agency could exercise its discretion in implementing the statute. However, the court was clear that DoD could, in exercising its discretion, reissue a rule with the same substantive requirements. In view of this conclusion, the court decided not to vacate the TRRx Final Rule, thereby leaving the voluntary agreement program in place.
In addressing the substantive issue presented, the court agreed with DoD that the statute entitles DoD to FCP-based pricing as of January 28, 2008. The court rejected the Coalition's argument that the Final Rule was impermissibly retroactive, holding instead that "[i]t is the statute, not the rule, which made transactions on or after January 28, 2008, subject to Federal Ceiling Prices . . . ." The court did not analyze how a rebate could be applied absent a contractual agreement by the manufacturer.
Accordingly, pending DoD's consideration on remand, the Final Rule remains in place as do TRRx voluntary rebate agreements. DoD is required to report to the court by March 1, 2010 on its reconsideration of the Final Rule.
It is likely that DoD will now turn its attention to outstanding rebate amounts for quarters pre-dating the voluntary agreements.
Whether this decision will have any impact on Non-FAMP and AMP remains to be seen. The VA has not yet stated whether this decision will impact its earlier guidance to manufacturers to identify and exclude TRRx utilization from Non-FAMP as Federal sales.
If you have any questions regarding this new TRRx development or surrounding the program generally, please contact Joy Sturm at (301) 294-5995 or at jesturm@hhlaw.com.
For the 11/30/09 Memorandum Opinion please see the following link: http://www.fdalawblog.net/files/mem.-op.-the-coalition-for-common-sense-.-.-.-v.-u.s.-08-cv-996-d.d.c.-nov.-30-209-2.pdf
*
daverice@cis-partners.com
As many of you may have heard, the United States District Court for the District of Columbia recently ruled on the Tricare Retail Pharmacy Program (TRRx) issue in a decision that surprised many, including myself. Below is some basic background information on the issue as well as analysis of the ruling that was provided to us by Joy Sturm, Partner, Hogan & Hartson LLP.
Background
On January 28, 2008, Congress enacted the National Defense Authorization Act for Fiscal Year 2008 ("NDAA-08"). Section 703 of NDAA-08 requires that pharmaceuticals paid for by the Department of Defense ("Department" or "DoD") under its TRICARE retail pharmacy program be subject to pricing standards known as Federal Ceiling Prices. The Department promulgated a final rule implementing section 703 on March 17, 2009. Under this rule, pharmaceutical manufacturers cannot receive more than the Federal Ceiling Prices for pharmaceuticals purchased by DoD for the retail pharmacy program, and must refund amounts in excess of the Federal Ceiling Prices for prescriptions filled on or after January 28, 2008. The Coalition for Common Sense in Government Procurement ("Coalition") challenged the Department's rule, asserted that the rule should be set aside because, inter alia, the Department erroneously interpreted NDAA-08 to require refunds by manufacturers to DoD and to require the statute's obligations to apply beginning on January 28, 2008.
Analysis of Ruling
In a surprising decision, on December 7 the U.S. District Court for the District of Columbia ruled that while the Department of Defense (DoD) did not follow proper procedures in issuing its Tricare Retail Pharmacy (TRRx) Final Rule (74 Fed. Reg. 11,279 (Mar. 17, 2009)) implementing Section 703 of the National Defense Authorization Act for FY 2008, the statute "requires that Federal Ceiling Prices apply to all retail pharmacy program prescriptions filled on or after January 28, 2008."
While the court found for the Coalition on its procedural challenge to the Final Rule, it sided with DoD on the substantive issue presented in the case. The court held that because Section 703 did not mandate a rebate program, DoD had been required to exercise its discretion in requiring rebates from manufacturers under its Final Rule. The court therefore concluded that DoD's statements throughout the Final Rule that such a program was required "by operation of law" by Section 703 rendered the Final Rule procedurally defective.
The court held that remand of the Final Rule was necessary so that the agency could exercise its discretion in implementing the statute. However, the court was clear that DoD could, in exercising its discretion, reissue a rule with the same substantive requirements. In view of this conclusion, the court decided not to vacate the TRRx Final Rule, thereby leaving the voluntary agreement program in place.
In addressing the substantive issue presented, the court agreed with DoD that the statute entitles DoD to FCP-based pricing as of January 28, 2008. The court rejected the Coalition's argument that the Final Rule was impermissibly retroactive, holding instead that "[i]t is the statute, not the rule, which made transactions on or after January 28, 2008, subject to Federal Ceiling Prices . . . ." The court did not analyze how a rebate could be applied absent a contractual agreement by the manufacturer.
Accordingly, pending DoD's consideration on remand, the Final Rule remains in place as do TRRx voluntary rebate agreements. DoD is required to report to the court by March 1, 2010 on its reconsideration of the Final Rule.
It is likely that DoD will now turn its attention to outstanding rebate amounts for quarters pre-dating the voluntary agreements.
Whether this decision will have any impact on Non-FAMP and AMP remains to be seen. The VA has not yet stated whether this decision will impact its earlier guidance to manufacturers to identify and exclude TRRx utilization from Non-FAMP as Federal sales.
If you have any questions regarding this new TRRx development or surrounding the program generally, please contact Joy Sturm at (301) 294-5995 or at jesturm@hhlaw.com.
For the 11/30/09 Memorandum Opinion please see the following link: http://www.fdalawblog.net/files/mem.-op.-the-coalition-for-common-sense-.-.-.-v.-u.s.-08-cv-996-d.d.c.-nov.-30-209-2.pdf
*
On the Fourth Day of CIS...
As reported to Jess Ebert, Compliance Specialist
On the fourth day of CIS, the blog introduced to me...
Compliance Manager Jon Dellaquila
(and Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)
Q: What’s your background?
A: After graduating from Circle of Friends pre-school in the spring of 1985, I went on to receive my undergraduate degree in Physiology from the University of Maryland (I thought I wanted to go to med school). My career began in a large pharmaceutical company supporting the development and monitoring of a Phase I/II Pilot Plant as an analytical chemist in the quality control laboratory. After a few years, I moved into the world of clinical trials supporting several Phase I/II oncology studies from an in-house clinical research associate perspective. Prior to my current position, I spent some time working in quality monitoring and compliance overseeing in-house and clinical site trial management activities in various therapeutic areas. During this time I also received my master’s degree in Cell Biology and Biotechnology from the University of the Sciences in Philadelphia.
Q: What projects and product lines do you work with at CIS?
A: I support CIS on the pharmaceutical side of the business in the clinical R&D and manufacturing arenas. Currently I am on-site at a client where I am responsible for assessing the risk benefit/analysis of R&D QA procedures and compliance related to the development of standard operating procedures (SOPs), policies and associated documents.
Q: Why did you decide to join CIS?
A: I decided to join CIS earlier this year to gain a different view of the pharmaceutical industry – from the outside looking in. Working for various departments within the industry allowed me to gain a strong understanding of the drug development life cycle from early stage R&D through to submission and approval. I always thought I wanted to get into pharmaceutical sales and found it difficult to break into that arena. When I interviewed with CIS, I saw the potential to wear many hats and also participate in various areas of the business. With that in mind, I thought it would be a perfect fit for me to leverage my career and educational experiences while also utilizing my social skills to create, establish and improve client relationships.
Q: What’s your favorite holiday cookie?
A: My Grandmom’s pizzelles - No one could make them like she could.
Q: What’s your favorite holiday movie?
A: My favorite holiday movie is National Lampoon’s Christmas Vacation. Christmas is not the same without a little Clark Griswald and cousin Eddie Johnson.
carpet, I wouldn't be more surprised than I am now." Email Jon any time at jondellaquila@cis-partners.com!
Currently there are:
9 days until Christmas,
10 days until Kwanzaa,
and 5 days until Winter Solstice!
Tonight is the 6th night of Chanukah!
On the fourth day of CIS, the blog introduced to me...
Compliance Manager Jon Dellaquila
(and Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)
Q: What’s your background?
A: After graduating from Circle of Friends pre-school in the spring of 1985, I went on to receive my undergraduate degree in Physiology from the University of Maryland (I thought I wanted to go to med school). My career began in a large pharmaceutical company supporting the development and monitoring of a Phase I/II Pilot Plant as an analytical chemist in the quality control laboratory. After a few years, I moved into the world of clinical trials supporting several Phase I/II oncology studies from an in-house clinical research associate perspective. Prior to my current position, I spent some time working in quality monitoring and compliance overseeing in-house and clinical site trial management activities in various therapeutic areas. During this time I also received my master’s degree in Cell Biology and Biotechnology from the University of the Sciences in Philadelphia.
Q: What projects and product lines do you work with at CIS?
A: I support CIS on the pharmaceutical side of the business in the clinical R&D and manufacturing arenas. Currently I am on-site at a client where I am responsible for assessing the risk benefit/analysis of R&D QA procedures and compliance related to the development of standard operating procedures (SOPs), policies and associated documents.
Q: Why did you decide to join CIS?
A: I decided to join CIS earlier this year to gain a different view of the pharmaceutical industry – from the outside looking in. Working for various departments within the industry allowed me to gain a strong understanding of the drug development life cycle from early stage R&D through to submission and approval. I always thought I wanted to get into pharmaceutical sales and found it difficult to break into that arena. When I interviewed with CIS, I saw the potential to wear many hats and also participate in various areas of the business. With that in mind, I thought it would be a perfect fit for me to leverage my career and educational experiences while also utilizing my social skills to create, establish and improve client relationships.
Q: What’s your favorite holiday cookie?
A: My Grandmom’s pizzelles - No one could make them like she could.
Q: What’s your favorite holiday movie?
A: My favorite holiday movie is National Lampoon’s Christmas Vacation. Christmas is not the same without a little Clark Griswald and cousin Eddie Johnson.
"Oh, Eddie... If I woke up tomorrow with my head sewn to the
carpet, I wouldn't be more surprised than I am now." Email Jon any time at jondellaquila@cis-partners.com!
Currently there are:
9 days until Christmas,
10 days until Kwanzaa,
and 5 days until Winter Solstice!
Tonight is the 6th night of Chanukah!
Tuesday, December 15, 2009
Reminder- Monthly GP Forum tomorrow, December 16th!!!
Please join several of the subject matter experts from CIS tomorrow at 10am for an hour long discussion on GP hot topics. The dial-in phone number is (888) 206-2266, and the pass-code is 1558717.
Topics for discussion include:
Topics for discussion include:
- Dave Rice will lead an update on the recent Tricare ruling. CIS will recode the call for an iPod download.
- Bill Baxter will give an update on the Advanced GP Forum venue at IIR in Baltimore in February.
- This is CIS’ 3rd year facilitating the full-day work shop, the agencies will be there to discuss topical issues in a “town hall” format.
- Any other questions or topics that you would like to discuss!
On the Third Day of CIS...
As reported to Jess Ebert, CIS Compliance Specialist
On the third day of CIS, the blog introduced to me...
Compliance Manager Chris Didizian
(and SCM Venessa Piper-Givler, and SCM Amy VanDeCar)
Q: What’s your background?
A: I have a degree in Ancient History & Archaeology. Right out of college, I was looking to join a law firm and had a few prospects lined up until I was contacted by CIS. Impressed with what I saw, I joined within a month of the first interview and have since worked on a variety of projects with a focus on Sales & Marketing Activities.
Q: What projects and product lines do you work with at CIS?
A: For product lines, I manage the content on PCX Sales & Marketing. As for projects, I end up on roles relating to commercial compliance, specifically promotional review (MLR), PDMA, State Reporting, followed up by a lot of process work.
Q: What do you like about CIS?
A: Where to begin? Well the easiest way might be to break this response into two parts. The first pertains to my career. CIS presents many opportunities to work on a variety of projects for all pharma, large or small. With that said, each employee brings different perspectives and experiences thus establishing a versatile, learning environment. The second part to this answer pertains to more of a personal level. The people here are passionate, knowledgeable, and fun to be around. I’d like to specifically highlight passionate because it is contagious and allows for an enjoyable work environment.
Q: What’s the best gift you ever gave someone for the holidays?
A: One year I was convinced that I had the best gift for my fiancé. The idea took me a while to come up with and when it finally came to me, I was ecstatic. This gift was sure to be a shoe-in! It was a GPS Navigation System for her car. Good idea, right?! Maybe not…it didn’t sparkle.
On Christmas Day she tore into the neatly wrapped gift (thank you Amazon for wrapping it – I still don’t know how) with a smile on her face as I sat watching giddy from the excitement. She looks at the picture on the box and with a very grim tone – smile replaced by a frown, asks, “What is it?” Please note I cleaned up her responses for our readers. After explaining the thought that went into it – trust me, the thought never counts when buying for a significant other – she made it clear, without even saying a word, that the next gift should sparkle. I guess that idea was a mistake, but we guys get at least one, right?
Q: What is your favorite holiday song?
A: I’m hoping nobody takes this the wrong way, but my favorite holiday song is “Grandma got run over by a reindeer.” I’ve often found myself driving around town volume raised, dancing, and singing to this loveable, countryesque classic. Sure, I’ve had a few close calls (driving and dancing are difficult for me!) and people may stare, laugh, or shout expletives (one time) but what’s not to love? Oh… and if you’re wondering… yes, I have it on my Ipod.
Email Chris any time at chrisdidizian@cis-partners.com!
Currently there are:
10 days until Christmas,
11 days until Kwanzaa,
and 6 days until Winter Solstice!
Tonight is the 5th night of Chanukah!
On the third day of CIS, the blog introduced to me...
Compliance Manager Chris Didizian
(and SCM Venessa Piper-Givler, and SCM Amy VanDeCar)
Q: What’s your background?
A: I have a degree in Ancient History & Archaeology. Right out of college, I was looking to join a law firm and had a few prospects lined up until I was contacted by CIS. Impressed with what I saw, I joined within a month of the first interview and have since worked on a variety of projects with a focus on Sales & Marketing Activities.
Q: What projects and product lines do you work with at CIS?
A: For product lines, I manage the content on PCX Sales & Marketing. As for projects, I end up on roles relating to commercial compliance, specifically promotional review (MLR), PDMA, State Reporting, followed up by a lot of process work.
Q: What do you like about CIS?
A: Where to begin? Well the easiest way might be to break this response into two parts. The first pertains to my career. CIS presents many opportunities to work on a variety of projects for all pharma, large or small. With that said, each employee brings different perspectives and experiences thus establishing a versatile, learning environment. The second part to this answer pertains to more of a personal level. The people here are passionate, knowledgeable, and fun to be around. I’d like to specifically highlight passionate because it is contagious and allows for an enjoyable work environment.
Q: What’s the best gift you ever gave someone for the holidays?
A: One year I was convinced that I had the best gift for my fiancé. The idea took me a while to come up with and when it finally came to me, I was ecstatic. This gift was sure to be a shoe-in! It was a GPS Navigation System for her car. Good idea, right?! Maybe not…it didn’t sparkle.
On Christmas Day she tore into the neatly wrapped gift (thank you Amazon for wrapping it – I still don’t know how) with a smile on her face as I sat watching giddy from the excitement. She looks at the picture on the box and with a very grim tone – smile replaced by a frown, asks, “What is it?” Please note I cleaned up her responses for our readers. After explaining the thought that went into it – trust me, the thought never counts when buying for a significant other – she made it clear, without even saying a word, that the next gift should sparkle. I guess that idea was a mistake, but we guys get at least one, right?
Q: What is your favorite holiday song?
A: I’m hoping nobody takes this the wrong way, but my favorite holiday song is “Grandma got run over by a reindeer.” I’ve often found myself driving around town volume raised, dancing, and singing to this loveable, countryesque classic. Sure, I’ve had a few close calls (driving and dancing are difficult for me!) and people may stare, laugh, or shout expletives (one time) but what’s not to love? Oh… and if you’re wondering… yes, I have it on my Ipod.
Email Chris any time at chrisdidizian@cis-partners.com!
Currently there are:
10 days until Christmas,
11 days until Kwanzaa,
and 6 days until Winter Solstice!
Tonight is the 5th night of Chanukah!
Monday, December 14, 2009
On the Second Day of CIS...
As reported to Jess Ebert, CIS Compliance Specialist
On the second day of CIS, the blog introduced to me...
Senior Compliance Manager Venessa Piper-Givler
(and SCM Amy VanDeCar)
Q: What's your background?
A: I have spent the majority of my career in GMP manufacturing specifically in final dosage, Active Pharmaceutical Ingredients, Sterile final and bulk as well as biologics. I started out in Quality Control as a bench chemist and microbiologist and then became a Supervisor of a QC laboratory. From there I moved into Quality Assurance and became a QA Manager and then a Director of Quality with QC, QA and Regulatory reporting into my organization. I hold a BS in Biochemistry and a Master's in Microbiology.
Q: What projects and product lines do you work with at CIS?
A: I work in the area of GMP Manufacturing specifically in Quality/Regulatory. I work with Quality and Regulatory clients to set up quality systems, metrics, evaluate and harmonization procedures, perform internal and external audits and establish regulatory filings.
Q: What do you like about CIS?
A: As a consultant for CIS I am given the opportunity to use my skills in many areas of Quality and Regulatory. CIS also allows me to work with many clients to help them with their compliance with the regulatory guidances as well as their own internal standards. This opportunity has also allowed me to use and enhance my business skills to develop a strong manufacturing program.
Q: What's your favorite holiday tradition?
A: A Traditional Italian Christmas Eve Dinner!
Q: What are you most thankful for this holiday season?
A: I'm most thankful for my children, family and friends.
Q: What is your favorite holiday song?
A: My favorite song is Last Christmas.
Email Venessa any time at vanessapiper-givler@cis-partners.com!
There are currently:
11 days until Christmas,
12 days until Kwanzaa,
and 7 days until Winter Solstice!
Tonight is the 4th night of Chanukah!
On the second day of CIS, the blog introduced to me...
Senior Compliance Manager Venessa Piper-Givler
(and SCM Amy VanDeCar)
Q: What's your background?
A: I have spent the majority of my career in GMP manufacturing specifically in final dosage, Active Pharmaceutical Ingredients, Sterile final and bulk as well as biologics. I started out in Quality Control as a bench chemist and microbiologist and then became a Supervisor of a QC laboratory. From there I moved into Quality Assurance and became a QA Manager and then a Director of Quality with QC, QA and Regulatory reporting into my organization. I hold a BS in Biochemistry and a Master's in Microbiology.
Q: What projects and product lines do you work with at CIS?
A: I work in the area of GMP Manufacturing specifically in Quality/Regulatory. I work with Quality and Regulatory clients to set up quality systems, metrics, evaluate and harmonization procedures, perform internal and external audits and establish regulatory filings.
Q: What do you like about CIS?
A: As a consultant for CIS I am given the opportunity to use my skills in many areas of Quality and Regulatory. CIS also allows me to work with many clients to help them with their compliance with the regulatory guidances as well as their own internal standards. This opportunity has also allowed me to use and enhance my business skills to develop a strong manufacturing program.
Q: What's your favorite holiday tradition?
A: A Traditional Italian Christmas Eve Dinner!
Q: What are you most thankful for this holiday season?
A: I'm most thankful for my children, family and friends.
Q: What is your favorite holiday song?
A: My favorite song is Last Christmas.
Email Venessa any time at vanessapiper-givler@cis-partners.com!
There are currently:
11 days until Christmas,
12 days until Kwanzaa,
and 7 days until Winter Solstice!
Tonight is the 4th night of Chanukah!
Friday, December 11, 2009
Articles of the Week!
Courtesy of: Scott Hoffman, CIS Senior Associate
scotthoffman@cis-partners.com
1) House, Senate health care bills grow further apart
http://www.cnn.com/2009/POLITICS/12/09/health.care.differences/index.html
2) Democrats Feud Over Drug Imports Amendment in Health Care Bill
http://www.foxnews.com/politics/2009/12/10/democrats-feud-drug-imports-amendment-health-care/
3) SEC probes four Pharmas for insider trading
http://www.fiercepharma.com/story/sec-probes-four-pharmas-insider-trading/2009-12-10
4) Microsoft To Acquire Healthcare Specialist http://www.informationweek.com/news/infrastructure/management/showArticle.jhtml?articleID=222001574
5) GAO: FDA yet to make safety changes post-Vioxx
http://news.yahoo.com/s/ap/20091209/ap_on_he_me/us_fda_drug_safety
6) Primary care shortages hitting communities hard
http://www.cnn.com/2009/POLITICS/12/10/king.sotu.doctors/index.html
7) Another Medical School Reports Doctors’ Industry Ties
http://blogs.wsj.com/health/2009/12/09/another-medical-school-reports-doctors-industry-ties/
scotthoffman@cis-partners.com
1) House, Senate health care bills grow further apart
http://www.cnn.com/2009/POLITICS/12/09/health.care.differences/index.html
2) Democrats Feud Over Drug Imports Amendment in Health Care Bill
http://www.foxnews.com/politics/2009/12/10/democrats-feud-drug-imports-amendment-health-care/
3) SEC probes four Pharmas for insider trading
http://www.fiercepharma.com/story/sec-probes-four-pharmas-insider-trading/2009-12-10
4) Microsoft To Acquire Healthcare Specialist http://www.informationweek.com/news/infrastructure/management/showArticle.jhtml?articleID=222001574
5) GAO: FDA yet to make safety changes post-Vioxx
http://news.yahoo.com/s/ap/20091209/ap_on_he_me/us_fda_drug_safety
6) Primary care shortages hitting communities hard
http://www.cnn.com/2009/POLITICS/12/10/king.sotu.doctors/index.html
7) Another Medical School Reports Doctors’ Industry Ties
http://blogs.wsj.com/health/2009/12/09/another-medical-school-reports-doctors-industry-ties/
Thursday, December 10, 2009
On the First Day of CIS...
Dear Readers,
It’s that time of the year again when we take the opportunity to introduce to you some of our talented employees who have made CIS an industry-leading provider of pharmaceutical compliance services.
For those of you who know us, you may just learn a thing or two about who we are and what makes us tick. For those of you who have not had the great pleasure of meeting us, we hope you like what you read!
Thanks, and Happy Holidays!
Dana Zelig and Jess Ebert, CIS Compliance Specialists and PCB Co-Editors
On the first day of CIS, the blog introduced to me...
Senior Compliance Manager Amy VanDeCar
Q: What's your background?
A: I have a degree in criminal justice and am working on an MBA. I got my start in pharma as a membership coordinator at a mid-sized manufacturer. I've worked in industry with chargebacks, contracts, analysis, and government pricing. After leaving industry, I spent a couple of years helping manufacturers implement and more extensively use commercial contracting and government pricing systems.
Q: What projects and product lines do you work with at CIS?
A: I am a Director in CIS' Commercial Compliance practice. In this role, I work with manufacturers on commercial and government programs audits and assessments, ongoing calculations and recalculations, and other projects intended to increase their level of compliance.
Q: What do you like about CIS?
A: I enjoy the variety of projects I am able to work on at CIS.
Q: Why did you decide to join CIS?
A: I joined CIS because of the company's unwavering commitment to compliance. I was drawn to the opportunity to work for a company that proactively informs customers about new and pending regulations and works with them to ensure a successful response.
Q: What are you looking forward to this holiday season?
A: The opportunity to slow down a bit, to take the time to enjoy family and friends.
Q: What is your favorite holiday song?
A: My favorite song is Silent Night.
Email Amy any time at amyvandecar@cis-partners.com!
There are currently:
16 days until Christmas,
2 days until Chanukah,
17 days until Kwanzaa, and
12 days until Winter Solstice!
It’s that time of the year again when we take the opportunity to introduce to you some of our talented employees who have made CIS an industry-leading provider of pharmaceutical compliance services.
For those of you who know us, you may just learn a thing or two about who we are and what makes us tick. For those of you who have not had the great pleasure of meeting us, we hope you like what you read!
Thanks, and Happy Holidays!
Dana Zelig and Jess Ebert, CIS Compliance Specialists and PCB Co-Editors
On the first day of CIS, the blog introduced to me...
Senior Compliance Manager Amy VanDeCar
Q: What's your background?
A: I have a degree in criminal justice and am working on an MBA. I got my start in pharma as a membership coordinator at a mid-sized manufacturer. I've worked in industry with chargebacks, contracts, analysis, and government pricing. After leaving industry, I spent a couple of years helping manufacturers implement and more extensively use commercial contracting and government pricing systems.
Q: What projects and product lines do you work with at CIS?
A: I am a Director in CIS' Commercial Compliance practice. In this role, I work with manufacturers on commercial and government programs audits and assessments, ongoing calculations and recalculations, and other projects intended to increase their level of compliance.
Q: What do you like about CIS?
A: I enjoy the variety of projects I am able to work on at CIS.
Q: Why did you decide to join CIS?
A: I joined CIS because of the company's unwavering commitment to compliance. I was drawn to the opportunity to work for a company that proactively informs customers about new and pending regulations and works with them to ensure a successful response.
Q: What are you looking forward to this holiday season?
A: The opportunity to slow down a bit, to take the time to enjoy family and friends.
Q: What is your favorite holiday song?
A: My favorite song is Silent Night.
Email Amy any time at amyvandecar@cis-partners.com!
There are currently:
16 days until Christmas,
2 days until Chanukah,
17 days until Kwanzaa, and
12 days until Winter Solstice!
Wednesday, December 9, 2009
CIS and Wrinkled Shirts
By: Steven Moore, CIS Director of Business Development
stevenmoore@cis-partners.com
I do a lot of traveling by myself and that means I get to do a lot of thinking to myself. Allow myself to introduce myself. Welcome to the department of redundancy department…
Nice, opening Steven. (I had thought about starting over, but this is actually what I typed, so I’m sticking with it.)
I’m not sure if you’ve heard about this whole Tiger Woods saga or not (for those of you who are reading this from Timbuktu --- which is for Dave Rice), but it really had got me to doing some real thinking. I was perplexed with how someone who is/was married to a model, who possesses more talent than anyone I’d ever seen at his craft, who is the first BILLION dollar athlete and has all the things money can buy could be so insecure and unhappy.
I rather like the saying, “The older I get, the smarter my parents get.” Because when I asked those questions to myself, the answer smacked me in the face (thanks Mom & Dad). Because money simply can’t buy happiness! Tiger can hit a golf ball 340 yards in the air. I love my wife so much that what he’s done to his wife Elin is impossible to fathom in my head. I’m happy.
I do feel for him and his family --- especially his wife and children --- and I hope that he can learn from his mistakes and become a better man. Heck, in reality, I feel like he needs to become a man first before he can become a better man. But my sincere best wishes.
So how does Tiger Woods relate to the Pharma Compliance Blog? Good question. I’ve been doing a lot of talking with Chris Cobourn, our VP of Consulting/GP/Calamari, etc., and we’ve talked a lot about how our people are ‘real’. That there is seemingly an important distinction between the folks at CIS and many of the places and organizations that we’ve seen. Now, he has seen a lot more places because I’m a spritely 30 and he’s, well, he’s tried a lot of different types of calamari --- but we both arrived at the same place having spent many a day on the road together. And, to tie things back to Tiger Woods, he’s been a fake for years now! But it’s one thing to think it of yourself and altogether different for someone else to say it to you.
I was recently in a meeting with a current client --- one whom I have a tremendous amount of respect for --- and was told, “I want you to know that we went with CIS because you’re real people that we can relate to. Sure, you work hard and you do strong work, but it was the fact that you were real that made us go with you.”
Pinch me. If I wasn’t such a tough guy (yeah right), I might have shed a tear. Seriously though, this was it! This was what we’d been trying to accomplish years ago! I also had another client tell us that a competitor rolled up in a shiny giant SUV and Armani suits --- and here I’m thinking, “Man, I wonder if I still know how to tie a tie…?”
When I came to CIS, my responsibility was marketing and marketing alone. I had met with the likes of Jim Collins, Toni Barsh, Chris Cobourn, Clarissa Crain and Chrissy Spicer and it was astonishing how real these people were. Having come from a large company filled with politics and back-stabbing, I was overwhelmed in a good way. These were the kinds of folks that you could see grabbing a pizza working till 1AM to finish a COT deliverable (for you, Clarissa) --- just as easily as you could see having a cold beer with them after a really long day. I then realized that my job was to let the Pharma Compliance world know and then, subsequently, see it. Most companies would be aghast at the notion of a PCXTini --- a neon blue martini named for our PCX product --- to launch our product at a conference. But guess what? A martini after 8 hours of GP talk at a conference is real!
Since those days, I’ve moved on to do some consulting projects and then into business development --- but have passed the marketing gig to the far more capable than me hands of Karen Brown and Jackie O’Connor. People loved our GP Geek T-shirts and many clients have told me they wear them out --- even to the gym! People loved that we used drink stirrers that lit up and were used in our CalcTinis, used for our CalcPartner product --- which if you haven’t seen or learned about yet, you must! (selling OFF) I had one client tell me that she keeps it in her purse and uses it at the bar! Now that is some serious word of mouth advertising. Not that every club and bar is crawling with GP and Compliance Geeks but as the NY Lotto says, “Hey, you never know…”
Karen, our aforementioned Sr. Director of Marketing, once asked of the CIS team the following brilliant, angled question: If CIS were a piece of furniture, what would it be and why?
At first I was confused --- but her tact was bright and she knew what she was doing. This is my exact response from an email sent back to her (I’m an email packrat --- my apologies to our server):
This isn’t supposed to be a piece that ‘toots our own horn’, but we do hope you agree. We have and will make mistakes, but we will be the first to raise our hands, admit it and make it right no matter what it takes. In the end, we hope you see that we’re real and we’ll work our butts off for you --- and if we ever waver from this, please do let us know. We many not wear Armani suits everywhere we go, but our shirts will be pressed…
However, more importantly, we won’t be afraid to get them wrinkled by rolling up our sleeves to finish your important deliverable ahead of time so you can present to management on a tight timeline --- or get you a proposal quickly because the fits about to hit the shan and you need our help.
I know the folks here at CIS, and that’s something real that you can count on.
For Your Space,
Steven.
stevenmoore@cis-partners.com
I do a lot of traveling by myself and that means I get to do a lot of thinking to myself. Allow myself to introduce myself. Welcome to the department of redundancy department…
Nice, opening Steven. (I had thought about starting over, but this is actually what I typed, so I’m sticking with it.)
I’m not sure if you’ve heard about this whole Tiger Woods saga or not (for those of you who are reading this from Timbuktu --- which is for Dave Rice), but it really had got me to doing some real thinking. I was perplexed with how someone who is/was married to a model, who possesses more talent than anyone I’d ever seen at his craft, who is the first BILLION dollar athlete and has all the things money can buy could be so insecure and unhappy.
I rather like the saying, “The older I get, the smarter my parents get.” Because when I asked those questions to myself, the answer smacked me in the face (thanks Mom & Dad). Because money simply can’t buy happiness! Tiger can hit a golf ball 340 yards in the air. I love my wife so much that what he’s done to his wife Elin is impossible to fathom in my head. I’m happy.
I do feel for him and his family --- especially his wife and children --- and I hope that he can learn from his mistakes and become a better man. Heck, in reality, I feel like he needs to become a man first before he can become a better man. But my sincere best wishes.
So how does Tiger Woods relate to the Pharma Compliance Blog? Good question. I’ve been doing a lot of talking with Chris Cobourn, our VP of Consulting/GP/Calamari, etc., and we’ve talked a lot about how our people are ‘real’. That there is seemingly an important distinction between the folks at CIS and many of the places and organizations that we’ve seen. Now, he has seen a lot more places because I’m a spritely 30 and he’s, well, he’s tried a lot of different types of calamari --- but we both arrived at the same place having spent many a day on the road together. And, to tie things back to Tiger Woods, he’s been a fake for years now! But it’s one thing to think it of yourself and altogether different for someone else to say it to you.
I was recently in a meeting with a current client --- one whom I have a tremendous amount of respect for --- and was told, “I want you to know that we went with CIS because you’re real people that we can relate to. Sure, you work hard and you do strong work, but it was the fact that you were real that made us go with you.”
Pinch me. If I wasn’t such a tough guy (yeah right), I might have shed a tear. Seriously though, this was it! This was what we’d been trying to accomplish years ago! I also had another client tell us that a competitor rolled up in a shiny giant SUV and Armani suits --- and here I’m thinking, “Man, I wonder if I still know how to tie a tie…?”
When I came to CIS, my responsibility was marketing and marketing alone. I had met with the likes of Jim Collins, Toni Barsh, Chris Cobourn, Clarissa Crain and Chrissy Spicer and it was astonishing how real these people were. Having come from a large company filled with politics and back-stabbing, I was overwhelmed in a good way. These were the kinds of folks that you could see grabbing a pizza working till 1AM to finish a COT deliverable (for you, Clarissa) --- just as easily as you could see having a cold beer with them after a really long day. I then realized that my job was to let the Pharma Compliance world know and then, subsequently, see it. Most companies would be aghast at the notion of a PCXTini --- a neon blue martini named for our PCX product --- to launch our product at a conference. But guess what? A martini after 8 hours of GP talk at a conference is real!
Since those days, I’ve moved on to do some consulting projects and then into business development --- but have passed the marketing gig to the far more capable than me hands of Karen Brown and Jackie O’Connor. People loved our GP Geek T-shirts and many clients have told me they wear them out --- even to the gym! People loved that we used drink stirrers that lit up and were used in our CalcTinis, used for our CalcPartner product --- which if you haven’t seen or learned about yet, you must! (selling OFF) I had one client tell me that she keeps it in her purse and uses it at the bar! Now that is some serious word of mouth advertising. Not that every club and bar is crawling with GP and Compliance Geeks but as the NY Lotto says, “Hey, you never know…”
Karen, our aforementioned Sr. Director of Marketing, once asked of the CIS team the following brilliant, angled question: If CIS were a piece of furniture, what would it be and why?
At first I was confused --- but her tact was bright and she knew what she was doing. This is my exact response from an email sent back to her (I’m an email packrat --- my apologies to our server):
“If CIS were a piece of furniture, it would be a well-constructed, reliable
desk. To me, this imagery represents roll-up-your-sleeves hard work and
dedication and that’s what we’re about now --- and hopefully well into the
future!”
This isn’t supposed to be a piece that ‘toots our own horn’, but we do hope you agree. We have and will make mistakes, but we will be the first to raise our hands, admit it and make it right no matter what it takes. In the end, we hope you see that we’re real and we’ll work our butts off for you --- and if we ever waver from this, please do let us know. We many not wear Armani suits everywhere we go, but our shirts will be pressed…
However, more importantly, we won’t be afraid to get them wrinkled by rolling up our sleeves to finish your important deliverable ahead of time so you can present to management on a tight timeline --- or get you a proposal quickly because the fits about to hit the shan and you need our help.
I know the folks here at CIS, and that’s something real that you can count on.
For Your Space,
Steven.
Friday, December 4, 2009
Articles of the Week!
Courtesy of: Jess Ebert, CIS Compliance Associate
jessicaebert@cis-partners.com
1) Hawaii Opting Out Of Health Care Overhaul
http://www.npr.org/templates/story/story.php?storyId=120896275&ps=cprs
2) Costs and Consequences of Direct-to-Consumer Advertising for Clopidogrel in Medicaid
http://archinte.ama-assn.org/cgi/content/short/169/21/1969?home
3) The Uproar Over Mammography
http://economix.blogs.nytimes.com/2009/11/20/the-uproar-over-mammography/
4) Health Care Rationing, American-Style
http://economix.blogs.nytimes.com/2009/11/27/health-care-rationing-american-style/
5) Bureau of Labor Statistics' Health Care Charts:
http://www.bls.gov/spotlight/2009/health_care/
jessicaebert@cis-partners.com
1) Hawaii Opting Out Of Health Care Overhaul
http://www.npr.org/templates/story/story.php?storyId=120896275&ps=cprs
2) Costs and Consequences of Direct-to-Consumer Advertising for Clopidogrel in Medicaid
http://archinte.ama-assn.org/cgi/content/short/169/21/1969?home
3) The Uproar Over Mammography
http://economix.blogs.nytimes.com/2009/11/20/the-uproar-over-mammography/
4) Health Care Rationing, American-Style
http://economix.blogs.nytimes.com/2009/11/27/health-care-rationing-american-style/
5) Bureau of Labor Statistics' Health Care Charts:
http://www.bls.gov/spotlight/2009/health_care/
Thursday, December 3, 2009
Managing Non-Compliance Incidents
Karen Brown - Senior Director, Marketing
karenbrown@cis-partners.com
Does your company's Compliance Program address the significant risks of the organization? How were those risks determined and how are new compliance risks identified and incorporated into the program?
These are questions posed by the OIG in their effort to develop specific guidances that best support a Compliance Program. [1]
The OIG’s “voluntary guidelines” are intended to help identify risk areas and offer suggestions for improvements. However, the act of implementation and management of a successful Compliance Program is going to require much more than sound advice and guidelines.
Think about your own company and the programs that you run and the many rules that could be broken across the organization.
As an industry already overloaded with vast amounts of data, one of the questions that we should be asking is: How is your company evaluating compliance throughout the organization?
CIS has been working with pharma clients to address this question and has developed an easy-to-use database solution.
Join us on Dec 8th, for a free WebEx on CIS ComplianceWatch: a compliance monitoring solution that will help you track non-compliant activities and disciplinary actions within your organization. This easy-to-use database allows you to:
· Capture non-compliant activities by individuals
· Attach the disciplinary action of an incident
· Escalate disciplinary actions based on repeat offenses
The database offers reporting options that will help you evaluate the entire Compliance Program based on the frequency of certain incidents, or evaluate compliance on an individual, district or company-wide basis. And, we can tailor ComplianceWatch to fit your current Compliance Program.
Please join us at a time that is convenient for you.
Date: Tuesday, December 8th
Times Available (EST): 10-10:30am, 1-1:30pm, 3-3:30pm Simply email us and let us know which time and we'll provide the call-in details.
If you're unable to join, email us and we'll setup an individual WebEx meeting.
Source:
[1] http://oig.hhs.gov/fraud/docs/complianceguidance/040203CorpRespRsceGuide.pdf
karenbrown@cis-partners.com
Does your company's Compliance Program address the significant risks of the organization? How were those risks determined and how are new compliance risks identified and incorporated into the program?
These are questions posed by the OIG in their effort to develop specific guidances that best support a Compliance Program. [1]
The OIG’s “voluntary guidelines” are intended to help identify risk areas and offer suggestions for improvements. However, the act of implementation and management of a successful Compliance Program is going to require much more than sound advice and guidelines.
Think about your own company and the programs that you run and the many rules that could be broken across the organization.
As an industry already overloaded with vast amounts of data, one of the questions that we should be asking is: How is your company evaluating compliance throughout the organization?
CIS has been working with pharma clients to address this question and has developed an easy-to-use database solution.
Join us on Dec 8th, for a free WebEx on CIS ComplianceWatch: a compliance monitoring solution that will help you track non-compliant activities and disciplinary actions within your organization. This easy-to-use database allows you to:
· Capture non-compliant activities by individuals
· Attach the disciplinary action of an incident
· Escalate disciplinary actions based on repeat offenses
The database offers reporting options that will help you evaluate the entire Compliance Program based on the frequency of certain incidents, or evaluate compliance on an individual, district or company-wide basis. And, we can tailor ComplianceWatch to fit your current Compliance Program.
Please join us at a time that is convenient for you.
Date: Tuesday, December 8th
Times Available (EST): 10-10:30am, 1-1:30pm, 3-3:30pm Simply email us and let us know which time and we'll provide the call-in details.
If you're unable to join, email us and we'll setup an individual WebEx meeting.
Source:
[1] http://oig.hhs.gov/fraud/docs/complianceguidance/040203CorpRespRsceGuide.pdf
Wednesday, December 2, 2009
Internet Drug Marketing Regulations
By: Grete Dudek, CIS Compliance Associate
gretedudek@cis-partners.com
On November 12th and 13th, 2009 the FDA held a public hearing to discuss how drug manufacturers use the internet and social media tools to promote their products. Participation in the hearing was open to “all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry.”[1] The hearing mainly addressed two questions:
Representatives from drug companies made the case that online marketing and social media can help consumers by getting the word out on drug safety, and educating patients about illness and its management. Until this point, drug makers have either been proceeding very cautiously on the internet and social media sites, or not at all, saying they’ve abstained because of a lack of direction from the FDA. They want to see concrete guidelines on what type of information they are responsible for, if they are responsible for correcting incorrect or misleading information on third party sites, and to what extent. But can manufacturers be responsible for every comment posted by random web surfers?
Back in March, warning letters were sent to 14 manufacturers from the FDA regarding paid Google search advertisements.[3] The letters from the FDA said that the drug advertisements were misleading because they didn’t have information on side effects, while the manufacturers warned that including that information was impossible, given the 95 character limit of Google ads. Before the letters were sent, the manufacturers believed they were in compliance if they followed the “one-click rule:” as long as risk information was provided within one click of the search ads, they thought they were in compliance with FDA regulations.[4] The letters proved this was not the case. If the safety information needs to be included in the 95 character ads, manufactures argued, the ads would become very confusing to consumers. As a result of the changes, a large drop was seen in the number of clicks the ads received.
From this example, it is clear that the FDA and manufacturers don’t always agree on how the current marketing regulations apply to internet and social media advertisements. Because the current regulations were written mainly to apply to print and television ads, and because of how the internet has grown, it is important that the FDA issue some sort of guidance. But the last time the FDA held a hearing about using the internet to promote medical products was in 1996, and that meeting yielded no guidelines on using the internet for the promotion of medical products.[2] The type of guidance that is needed is also important to consider, since the rules should be strict enough to not allow misinterpretation (as seen with the “one-click rule”), but need to be flexible enough to allow for the ever-changing internet and the world of social media.
The FDA will be accepting comments until February 28, 2010 at www.regulations.gov.
Sources:
1. http://edocket.access.gpo.gov/2009/pdf/E9-22618.pdf
2. http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/11/fdas-hearing-on-social-media-more-questions-no-answers.html
3. http://www.fiercepharma.com/story/another-job-fda-online-marketing-regs/2009-04-07
4. http://pharmamkting.blogspot.com/2009/04/fdas-actions-speak-louder-than-its.html
gretedudek@cis-partners.com
On November 12th and 13th, 2009 the FDA held a public hearing to discuss how drug manufacturers use the internet and social media tools to promote their products. Participation in the hearing was open to “all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry.”[1] The hearing mainly addressed two questions:
How do [drug marketing regulations] relate to certain internet/social
media-related activities; and what are manufacturers’ responsibilities with
regard to monitoring and subsequently reporting adverse events identified on the
internet and/or through social media tools.[2]
Representatives from drug companies made the case that online marketing and social media can help consumers by getting the word out on drug safety, and educating patients about illness and its management. Until this point, drug makers have either been proceeding very cautiously on the internet and social media sites, or not at all, saying they’ve abstained because of a lack of direction from the FDA. They want to see concrete guidelines on what type of information they are responsible for, if they are responsible for correcting incorrect or misleading information on third party sites, and to what extent. But can manufacturers be responsible for every comment posted by random web surfers?
Back in March, warning letters were sent to 14 manufacturers from the FDA regarding paid Google search advertisements.[3] The letters from the FDA said that the drug advertisements were misleading because they didn’t have information on side effects, while the manufacturers warned that including that information was impossible, given the 95 character limit of Google ads. Before the letters were sent, the manufacturers believed they were in compliance if they followed the “one-click rule:” as long as risk information was provided within one click of the search ads, they thought they were in compliance with FDA regulations.[4] The letters proved this was not the case. If the safety information needs to be included in the 95 character ads, manufactures argued, the ads would become very confusing to consumers. As a result of the changes, a large drop was seen in the number of clicks the ads received.
From this example, it is clear that the FDA and manufacturers don’t always agree on how the current marketing regulations apply to internet and social media advertisements. Because the current regulations were written mainly to apply to print and television ads, and because of how the internet has grown, it is important that the FDA issue some sort of guidance. But the last time the FDA held a hearing about using the internet to promote medical products was in 1996, and that meeting yielded no guidelines on using the internet for the promotion of medical products.[2] The type of guidance that is needed is also important to consider, since the rules should be strict enough to not allow misinterpretation (as seen with the “one-click rule”), but need to be flexible enough to allow for the ever-changing internet and the world of social media.
The FDA will be accepting comments until February 28, 2010 at www.regulations.gov.
Sources:
1. http://edocket.access.gpo.gov/2009/pdf/E9-22618.pdf
2. http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/11/fdas-hearing-on-social-media-more-questions-no-answers.html
3. http://www.fiercepharma.com/story/another-job-fda-online-marketing-regs/2009-04-07
4. http://pharmamkting.blogspot.com/2009/04/fdas-actions-speak-louder-than-its.html
Tuesday, December 1, 2009
Buyer Beware: FDA Issues Warning Related to H1N1 Drugs Purchased Online
By: Jeff Blake, CIS Senior Compliance Associate
jeffblake@cis-partners.com
It is estimated that approximately 1.7 billion people worldwide use the internet on a daily basis. [1] Further, it has been reported that 85% of these users have purchased goods and services online at one time or another. [1] Needless to say, the internet has drastically changed the way we shop, and has allowed for the creation of countless web sites that enable consumers to purchase goods and services online.
In the United States and Canada, one of the most controversial aspects of the online marketplace is the sale of prescription drugs over the internet. Online pharmacies allow individuals to purchase drugs from the comfort of their own homes, at rates that are more affordable than those available at a traditional pharmacy. In some cases, prescription drugs can be purchased on the internet without a valid prescription from a licensed physician. Thus, individuals without health insurance are purchasing the medicine they need at a fraction of the price being charged by retail pharmacies. Despite these apparent benefits, the U.S. Food and Drug Administration warns that consumers must use extreme caution when purchasing medications online. In their Consumer Safety Guide, the FDA states:
Some Web sites that sell medicine:
Sources:
[1] http://www.internetworldstats.com/
[2] http://www.fda.gov/Drugs/ResourcesForYou/ucm080588.htm
[3] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186861.htm
jeffblake@cis-partners.com
It is estimated that approximately 1.7 billion people worldwide use the internet on a daily basis. [1] Further, it has been reported that 85% of these users have purchased goods and services online at one time or another. [1] Needless to say, the internet has drastically changed the way we shop, and has allowed for the creation of countless web sites that enable consumers to purchase goods and services online.
In the United States and Canada, one of the most controversial aspects of the online marketplace is the sale of prescription drugs over the internet. Online pharmacies allow individuals to purchase drugs from the comfort of their own homes, at rates that are more affordable than those available at a traditional pharmacy. In some cases, prescription drugs can be purchased on the internet without a valid prescription from a licensed physician. Thus, individuals without health insurance are purchasing the medicine they need at a fraction of the price being charged by retail pharmacies. Despite these apparent benefits, the U.S. Food and Drug Administration warns that consumers must use extreme caution when purchasing medications online. In their Consumer Safety Guide, the FDA states:
Some Web sites that sell medicine:
- aren’t U.S. state-licensed pharmacies or aren’t pharmacies at all
- may give a diagnosis that is not correct and sell medicine that is not right for you or your condition
- won’t protect your personal information [2]
- are fake (counterfeit or “copycat” medicines)
- are too strong or too weak
- have dangerous ingredients
- have expired (are out-of-date)
- aren’t FDA-approved (haven't been checked for safety and effectiveness)
- aren’t made using safe standards
- aren’t safe to use with other medicine or products you use
- aren’t labeled, stored, or shipped correctly [2]
“arrived in an unmarked envelope with a postmark from India and consisted ofWithout the active ingredient, the medicine will not alleviate the symptoms caused by the H1N1 virus and; therefore, is not a viable treatment option to stop the spread of the virus. Furthermore, consumers can’t be certain of the ingredients contained in the online drugs, which may lead to undesirable side effects or, even worse, death. Margaret A. Hamburg, M.D., FDA Commissioner, stated:
unlabeled, white tablets taped between two pieces of paper. When analyzed by the
FDA, the tablets were found to contain talc and acetaminophen, but none of the
active ingredient oseltamivir.” [3]
“Products that are offered for sale online with claims to diagnose, prevent,The FDA urges consumers to purchase medications, including those to treat H1N1, from safe web sites that are located in the United States and are licensed by the applicable state Board of Pharmacy. The message is clear. If you are going to purchase drugs online, be sure to use extreme caution to protect yourself and your family.
mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully
evaluated. Medicines purchased from Web sites operating outside the law
put consumers at increased risk due to a higher potential that the products will
be counterfeit, impure, contaminated, or have too little or too much of the
active ingredient.” [3]
Sources:
[1] http://www.internetworldstats.com/
[2] http://www.fda.gov/Drugs/ResourcesForYou/ucm080588.htm
[3] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186861.htm
Wednesday, November 25, 2009
Articles of the Week!
Courtesy of: John Jordan, CIS Senior Compliance Associate
johnjordan@cis-partners.com
1) Are You Ready For The Revolution?
http://pharmexec.findpharma.com/pharmexec/Strategy/Are-You-Ready-For-The-Revolution/ArticleStandard/Article/detail/631737?contextCategoryId=48158
2) GOP Strikes Back On Senate Health Vote
http://www.kaiserhealthnews.org/Daily-Reports/2009/November/23/GOP-health-bill-react.aspx
3) Health Care Debate Revives Abortion Campaigners
http://www.nytimes.com/2009/11/24/health/policy/24abortion.html?_r=1&hp
4) N.F.L. to Shift in Its Handling of Concussions
http://www.nytimes.com/2009/11/23/sports/football/23concussion.html?ref=health
5) HHS Secretary Sebelius Announces Senate Confirmation Of Pamela Hyde As Administrator, Substance Abuse And Mental Health Services Administration
http://www.medicalnewstoday.com/articles/171864.php
6) A Guide: How The Health Bills Might Affect Consumers
http://www.medicalnewstoday.com/articles/171801.php
Have a Happy Thanksgiving!
johnjordan@cis-partners.com
1) Are You Ready For The Revolution?
http://pharmexec.findpharma.com/pharmexec/Strategy/Are-You-Ready-For-The-Revolution/ArticleStandard/Article/detail/631737?contextCategoryId=48158
2) GOP Strikes Back On Senate Health Vote
http://www.kaiserhealthnews.org/Daily-Reports/2009/November/23/GOP-health-bill-react.aspx
3) Health Care Debate Revives Abortion Campaigners
http://www.nytimes.com/2009/11/24/health/policy/24abortion.html?_r=1&hp
4) N.F.L. to Shift in Its Handling of Concussions
http://www.nytimes.com/2009/11/23/sports/football/23concussion.html?ref=health
5) HHS Secretary Sebelius Announces Senate Confirmation Of Pamela Hyde As Administrator, Substance Abuse And Mental Health Services Administration
http://www.medicalnewstoday.com/articles/171864.php
6) A Guide: How The Health Bills Might Affect Consumers
http://www.medicalnewstoday.com/articles/171801.php
Have a Happy Thanksgiving!
Friday, November 20, 2009
Articles of the Week!
Courtesy of: Debbe Saez, CIS Senior Compliance Manager
debbesaez@cis-partners.com
1) “Committee Leaders Call for GAO Analysis of Recent Prescription Drug Price Increases”
http://www.drugs.com/news/committee-leaders-call-gao-analysis-recent-price-increases-21015.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+Drugscom-HeadlineNews+%28Drugs.com+-+Headline+News%29
2) “Senate Health Bill Released, Another Step Toward Democratic-Backed Reforms”
http://www.kaiserhealthnews.org/Daily-Reports/2009/November/19/Senate-Health-Bill-Overview.aspx
3) “Lean Comes to Pharma”
http://pharmexec.findpharma.com/pharmexec/Strategy/Lean-Comes-to-Pharma/ArticleStandard/Article/detail/641195?contextCategoryId=48158
4) “FDA Issues 22 Warning Letters to Web Site Operators”
http://www.pharmalive.com/News/index.cfm?articleid=668327&categoryid=56
5) “Seniors Struggle With Drug Costs While Congress Debates Medicare 'Doughnut Hole"
http://www.medicalnewstoday.com/articles/171493.php
6) “How Do You Solve a Problem Like Sidewiki?”
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/11/how-do-you-solve-a-problem-like-sidewiki-our-apologies-to-the-sound-of-music.html?utm_source=feedburner&utm_medium=email
debbesaez@cis-partners.com
1) “Committee Leaders Call for GAO Analysis of Recent Prescription Drug Price Increases”
http://www.drugs.com/news/committee-leaders-call-gao-analysis-recent-price-increases-21015.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+Drugscom-HeadlineNews+%28Drugs.com+-+Headline+News%29
2) “Senate Health Bill Released, Another Step Toward Democratic-Backed Reforms”
http://www.kaiserhealthnews.org/Daily-Reports/2009/November/19/Senate-Health-Bill-Overview.aspx
3) “Lean Comes to Pharma”
http://pharmexec.findpharma.com/pharmexec/Strategy/Lean-Comes-to-Pharma/ArticleStandard/Article/detail/641195?contextCategoryId=48158
4) “FDA Issues 22 Warning Letters to Web Site Operators”
http://www.pharmalive.com/News/index.cfm?articleid=668327&categoryid=56
5) “Seniors Struggle With Drug Costs While Congress Debates Medicare 'Doughnut Hole"
http://www.medicalnewstoday.com/articles/171493.php
6) “How Do You Solve a Problem Like Sidewiki?”
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/11/how-do-you-solve-a-problem-like-sidewiki-our-apologies-to-the-sound-of-music.html?utm_source=feedburner&utm_medium=email
Thursday, November 19, 2009
Reform in Rare Form
By Sabrina Skari, CIS Business Development Manager
sabrinaskari@cis-partners.com
Saturday, November 7th marked a monumental moment in history for both the healthcare industry and the United States. After years of heated debate regarding healthcare reform, the House of Representatives narrowly passed the “Affordable Healthcare for America Act” or H.R. 3962 with only eight seconds left in the voting period. The bill passed with a vote of 220-215, and the body of Representatives who signed the bill into existence included only one Republican [1], marking one of the most partisan pieces of legislation ever passed in either house. It also represents the largest surge in healthcare coverage since the creation of Medicare in 1965.
The narrow passage of the bill speaks to the controversy surrounding HR 3692. Representative Jim Cooper (D-Tenn) called his vote for the bill “one of the best votes I ever cast.” However, this was not because of what the bill was but because of what the bill represented. Rep. Cooper said:
This bill has a tough road ahead and Representative Cooper made reference to this in his remarks. It will not be law until several steps, which many people see as impossible, happen. The Senate must pass its own version of the bill, while some key Senators are already referring to it as “dead on arrival.” Essentially, the bill needs the support of every independent and democratic Senator, including moderates, in order to pass. The chances of that happening seem slim due to one of the most hotly debated provisions in the bill - the creation of a government run health insurance program. At this point, the Senate hasn’t even scheduled time for floor debate [4]. If the Senate is able to eventually pass a version of the bill, then a Committee will merge the two proposals into a consensus version that requires final approval from the House, Senate and President Obama.
With all of the speculation on the process and its possible implications, how is the healthcare industry responding to the bill? The Blue Cross and Blue Shield Corporation released a statement, which stated:
sabrinaskari@cis-partners.com
Saturday, November 7th marked a monumental moment in history for both the healthcare industry and the United States. After years of heated debate regarding healthcare reform, the House of Representatives narrowly passed the “Affordable Healthcare for America Act” or H.R. 3962 with only eight seconds left in the voting period. The bill passed with a vote of 220-215, and the body of Representatives who signed the bill into existence included only one Republican [1], marking one of the most partisan pieces of legislation ever passed in either house. It also represents the largest surge in healthcare coverage since the creation of Medicare in 1965.
The narrow passage of the bill speaks to the controversy surrounding HR 3692. Representative Jim Cooper (D-Tenn) called his vote for the bill “one of the best votes I ever cast.” However, this was not because of what the bill was but because of what the bill represented. Rep. Cooper said:
“The key is to keep the reform process alive. There are many things in the House bill I disagree with. But the Senate bill is the more likely final product due to the difficulty of getting 60 votes over there. If we had dropped the baton at this stage, it wouldn’t have given the Senate a chance to improve the bill. It would have given the House what amounted to a one-chamber veto. The Senate could have powered through, but those folks are not noted for their courage. The House had to perform here. And I am thankful that in the nick of time the leadership realized how short they were on votes [2].”On the other hand, Representative Paul Ryan (R- WI) stated that “This is perhaps the worst bill I have seen come to the floor in my 11 years in Congress” and Republic leader John Boehner echoed Ryan’s sentiments when he stated that the requirement that individuals purchase insurance is "the most unconstitutional thing I've seen in my life [3]."
This bill has a tough road ahead and Representative Cooper made reference to this in his remarks. It will not be law until several steps, which many people see as impossible, happen. The Senate must pass its own version of the bill, while some key Senators are already referring to it as “dead on arrival.” Essentially, the bill needs the support of every independent and democratic Senator, including moderates, in order to pass. The chances of that happening seem slim due to one of the most hotly debated provisions in the bill - the creation of a government run health insurance program. At this point, the Senate hasn’t even scheduled time for floor debate [4]. If the Senate is able to eventually pass a version of the bill, then a Committee will merge the two proposals into a consensus version that requires final approval from the House, Senate and President Obama.
With all of the speculation on the process and its possible implications, how is the healthcare industry responding to the bill? The Blue Cross and Blue Shield Corporation released a statement, which stated:
“Instead of using this once-in-a-generation opportunity to expand coverage, rein in costs, and improve healthcare quality, the bill creates a new government-run plan that jeopardizes affordability and access to coverage for the 160million people who receive their benefits through their employers today; makes health coverage much more expensive, particularly for individuals and small employers; and represents a massive federal takeover of state regulatory functions [5].”
However, among those pleased with the new legislation are healthcare provider groups. The American Medical Association (AMA) released a statement proclaiming that the bill will “empower patient and physician decision making," as well as “kick off substantial insurance market restructuring, prevention and wellness initiatives and liability reforms.” The Medical Group Management Association (MGMA) says that the bill addresses four of its six core healthcare reform principles, which include: fixing the Medicare physician payment system, simplifying administrative transactions, enacting meaningful medical liability reform, expanding coverage, improving quality and safety, and finally, promoting the adoption of health information technology [6].
Regardless of the varying opinions swirling around this debate, everyone can agree on one thing; despite decades of failed reform efforts in the U.S., the passage of HR 3692 is historic because it has seen some success. One may cite the current downtrodden economic and political climate as a reason for why this bill was different. Perhaps it’s the momentum that President Obama brought into the office following his election. In any event, with the recession, war, a new political regime and a generation of baby boomers approaching Medicare eligibility, people are experiencing a perfect storm of events that may be impacting their perception.
The U.S. healthcare system must evolve to meet its population’s growing needs. Whether you are in favor of the proposed healthcare reforms or not, most people acknowledge that inaction is not an option. For all of the “hoopla” surrounding the events of last Saturday, let’s step back and note that whatever legislation emerges from this process, it will probably not take effect until 2013. We could even have another President in office by then. So for the time being, the responsible thing to do is to keep from making rash decisions based on “proposals” and to wait for direct guidance from the Federal Government, whenever that time comes.
Sources:
[1] http://www.cnn.com/2009/POLITICS/11/09/health.care/index.html
[2] http://voices.washingtonpost.com/ezra-klein/2009/11/rep_jim_cooper_house_health_ca.html
[3] http://www.politico.com/news/stories/1109/29282.html
[4] http://news.yahoo.com/s/ap/20091108/ap_on_bi_ge/us_health_care_overhaul
[5] http://www.fiercehealthcare.com/press-releases/house-bill-fails-deliver-affordable-healthcare-reform?utm_medium=nl&utm_source=internal
[6] http://www.fiercehealthcare.com/story/passage-health-reform-bill-house-dems-cheered-jeered/2009-11-09?utm_medium=nl&utm_source=internal
The Battle Against AIDS
By Craig Kubicek, CIS Compliance Associate
craigkubicek@cis-partners.com
Although HIV/AIDS is not as newsworthy nowadays as it was when it was first discovered in the 1980s, it affects 33.2 million world-wide and is a major concern for world leaders. [1] The world has been battling this disease for years and has recently been able to treat the symptoms of AIDS, as well as suppress the disease; however, no cure has been created by any governments, companies, or universities to this day. Due to the number of AIDS inflicted individuals throughout the world, there is a continual push for a cure.
Some drug companies have devoted entire sectors of their business to AIDS. As a matter of fact, Bristol-Myers Squibb has a new HIV/AIDS drug going through FDA approval as you read this.[2] To really strengthen the race to find a cure, two large pharmaceutical companies have combined their power to focus on the disease. [3] GlaxoSmithKline (GSK) and Pfizer are putting their heads together and have created a spinoff company called ViiV Healthcare. Dr. Dominique Limet, the Chief Executive Officer of ViiV Healthcare, explained, “Rising infection rates and increasingly complex treatment issues have created a challenging landscape in the treatment of HIV and the need for innovative research and better patient resources.” [4] GSK holds a majority share in ViiV Healthcare, but hopes to cooperatively work with Pfizer to find a solution to the ongoing AIDS pandemic.
ViiV healthcare currently sells 10 HIV/AIDS treatments and medicines. The sales of these products and services will provide the company with revenue to support its operations. According to GSK’s press release, “The company also has a pipeline of seven innovative and targeted medicines, including five compounds in phase II development. Altogether, ViiV Healthcare has 17 molecules in its portfolio to develop as potential new HIV treatments.”[5]
Bringing companies together to tackle illnesses is a great approach to solving many of humanity’s problems. Sometimes, one company alone does not have the knowledge or resources to meet the world’s needs. As time progresses, I hope to see more companies do the same. I am all for businesses and competition, but sometimes there is more to life than profits and revenue. If these endeavors are successful, cooperation may prove to be key to conquering HIV/AIDS.
[1] http://data.unaids.org/pub/EPISlides/2007/2007_epiupdate_en.pdf
[2] http://www.rttnews.com/Content/BreakingNews.aspx?Node=B1&Id=1120611%20&Category=Breaking%20News
[3] http://www.nytimes.com/2009/11/10/health/10glob.html
[4] http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10123.htm
[5] http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10123.htm
craigkubicek@cis-partners.com
Although HIV/AIDS is not as newsworthy nowadays as it was when it was first discovered in the 1980s, it affects 33.2 million world-wide and is a major concern for world leaders. [1] The world has been battling this disease for years and has recently been able to treat the symptoms of AIDS, as well as suppress the disease; however, no cure has been created by any governments, companies, or universities to this day. Due to the number of AIDS inflicted individuals throughout the world, there is a continual push for a cure.
Some drug companies have devoted entire sectors of their business to AIDS. As a matter of fact, Bristol-Myers Squibb has a new HIV/AIDS drug going through FDA approval as you read this.[2] To really strengthen the race to find a cure, two large pharmaceutical companies have combined their power to focus on the disease. [3] GlaxoSmithKline (GSK) and Pfizer are putting their heads together and have created a spinoff company called ViiV Healthcare. Dr. Dominique Limet, the Chief Executive Officer of ViiV Healthcare, explained, “Rising infection rates and increasingly complex treatment issues have created a challenging landscape in the treatment of HIV and the need for innovative research and better patient resources.” [4] GSK holds a majority share in ViiV Healthcare, but hopes to cooperatively work with Pfizer to find a solution to the ongoing AIDS pandemic.
ViiV healthcare currently sells 10 HIV/AIDS treatments and medicines. The sales of these products and services will provide the company with revenue to support its operations. According to GSK’s press release, “The company also has a pipeline of seven innovative and targeted medicines, including five compounds in phase II development. Altogether, ViiV Healthcare has 17 molecules in its portfolio to develop as potential new HIV treatments.”[5]
Bringing companies together to tackle illnesses is a great approach to solving many of humanity’s problems. Sometimes, one company alone does not have the knowledge or resources to meet the world’s needs. As time progresses, I hope to see more companies do the same. I am all for businesses and competition, but sometimes there is more to life than profits and revenue. If these endeavors are successful, cooperation may prove to be key to conquering HIV/AIDS.
[1] http://data.unaids.org/pub/EPISlides/2007/2007_epiupdate_en.pdf
[2] http://www.rttnews.com/Content/BreakingNews.aspx?Node=B1&Id=1120611%20&Category=Breaking%20News
[3] http://www.nytimes.com/2009/11/10/health/10glob.html
[4] http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10123.htm
[5] http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10123.htm
Friday, November 13, 2009
Articles of the Week!
Courtesy of: Gary Miller, CIS Senior Compliance Associate
garymiller@cis-partners.com
1) Google Unveils New Pharma Ads
http://blog.pharmexec.com/2009/11/12/google-unveils-new-pharma-ads/
2) Pharma’s Fourth Hurdle – Market Access
http://www.medicalnewstoday.com/articles/170769.php
3) Researchers Make Recommendations For Minimizing Harm And Maximizing Benefits of Drug Ads
http://www.medicalnewstoday.com/articles/170764.php
4) PhRMA Statement About Accessing Online Health Information
http://www.drugs.com/news/phrma-statement-accessing-online-health-information-20823.html
5) New Survey: More Than Half Of Americans Do Not Take Prescription Medicines As Instructed, Pointing To Growing Public Health Problem
http://www.medicalnewstoday.com/articles/170776.php
garymiller@cis-partners.com
1) Google Unveils New Pharma Ads
http://blog.pharmexec.com/2009/11/12/google-unveils-new-pharma-ads/
2) Pharma’s Fourth Hurdle – Market Access
http://www.medicalnewstoday.com/articles/170769.php
3) Researchers Make Recommendations For Minimizing Harm And Maximizing Benefits of Drug Ads
http://www.medicalnewstoday.com/articles/170764.php
4) PhRMA Statement About Accessing Online Health Information
http://www.drugs.com/news/phrma-statement-accessing-online-health-information-20823.html
5) New Survey: More Than Half Of Americans Do Not Take Prescription Medicines As Instructed, Pointing To Growing Public Health Problem
http://www.medicalnewstoday.com/articles/170776.php
Thursday, November 12, 2009
CIS to Speak and Exhibit at CBI
CIS will be speaking and exhibiting at CBI’s VA, DoD, PHS Federal Pricing and Contracts for Bio/Pharmaceutical Companies
When: Thursday, November 18th – Friday, November 19th
Where: Loews Hotel, Philadelphia, PA
Dave Rice, CIS Director of Federal Contracting, will be holding a half day Workshop entitled DoD, TRICARE and Uniform Formulary Refund Process Workshop, during which he will address the following important issues:
We hope to see you there!
*
When: Thursday, November 18th – Friday, November 19th
Where: Loews Hotel, Philadelphia, PA
Dave Rice, CIS Director of Federal Contracting, will be holding a half day Workshop entitled DoD, TRICARE and Uniform Formulary Refund Process Workshop, during which he will address the following important issues:
- TRRx Time line
- Uniform Formulary Tier 3 Review
- Status of Compromise Requests
- Status of Coalition Litigation
- How well defined is the refund process?
- How can one prevent errors in data handling and reporting?
- How can one ensure that data is accurate and verifiable?
- How does the DoD define retail class of trade?
We hope to see you there!
*
Wednesday, November 11, 2009
Proposed Rule for Post-marketing Safety Reporting of Combination Products
By: Annette Horner, CIS Senior Director, Clinical Consulting Services
annettehorner@cis-partners.com
If you or someone you know uses a combination product to treat an illness or medical condition, you can sleep better tonight. But, if your company markets a combination product in the United States, you may want to read on. The reporting of safety issues related to these products is going to become more thorough and clear-cut.
The FDA plans to plug a very large hole in the regulation of combination products – those that govern products formed from any combination of drugs, devices, or biological products. Current combination product rules fail to describe clear and concrete standards and timeframes for reporting post-marketing safety issues to the FDA.
The Proposed Rule, “Postmarketing Safety Reporting for Combination Products” will create 21 CFR Part 4, Subpart B.[1] The proposed rule is important because the safety reporting process for a combination product is governed by one of three sets of reporting provisions: 21 CFR Parts 310 and 314 for drugs; Parts 600 and 606 for biological products; and Part 803 for medical devices.
Currently, manufacturers of combination products must report safety issues to the FDA by following the regulations for the product component, under which the product was approved for marketing. For example, if a combination product was approved and marketed under an NDA, safety reporting follows the requirements of 21 CFR Part 314. However, this safety reporting method does not accommodate the unique safety reporting provisions for all product components, and could lead to a loss of information needed by the FDA to protect public health.
The proposed rule will remedy this potential loss of valuable safety information by requiring that reporters of postmarketing safety issues continue “. . . to comply with the requirements associated with the application used to approve or clear the combination product, as long as there is compliance, as appropriate, with the five unique provisions.”[2]
In the “Description of the Proposed Rule” the five unique provisions are clearly explained, and examples are provided (see the Proposed Rule for detail).[3] Once the proposed rule becomes effective (comments are due by December 30, 2009), combination product manufacturers will be required to provide more consistent and complete safety reports, and the FDA will have more information on combination products, upon which to make sound regulatory decisions about product safety and public health. In this era of rapidly developing medical technologies, this long-anticipated rule is making progress.
Sources:
[1] Federal Register/Vol. 74, No. 189/Thursday, October 1, 2009/Proposed Rules, pp. 50744-50758.
[2] Federal Register/Vol. 74, No. 189/Thursday, October 1, 2009/Proposed Rules, pp. 50750.
[3] http://edocket.access.gpo.gov/2009/pdf/E9-23519.pdf
annettehorner@cis-partners.com
If you or someone you know uses a combination product to treat an illness or medical condition, you can sleep better tonight. But, if your company markets a combination product in the United States, you may want to read on. The reporting of safety issues related to these products is going to become more thorough and clear-cut.
The FDA plans to plug a very large hole in the regulation of combination products – those that govern products formed from any combination of drugs, devices, or biological products. Current combination product rules fail to describe clear and concrete standards and timeframes for reporting post-marketing safety issues to the FDA.
The Proposed Rule, “Postmarketing Safety Reporting for Combination Products” will create 21 CFR Part 4, Subpart B.[1] The proposed rule is important because the safety reporting process for a combination product is governed by one of three sets of reporting provisions: 21 CFR Parts 310 and 314 for drugs; Parts 600 and 606 for biological products; and Part 803 for medical devices.
Currently, manufacturers of combination products must report safety issues to the FDA by following the regulations for the product component, under which the product was approved for marketing. For example, if a combination product was approved and marketed under an NDA, safety reporting follows the requirements of 21 CFR Part 314. However, this safety reporting method does not accommodate the unique safety reporting provisions for all product components, and could lead to a loss of information needed by the FDA to protect public health.
The proposed rule will remedy this potential loss of valuable safety information by requiring that reporters of postmarketing safety issues continue “. . . to comply with the requirements associated with the application used to approve or clear the combination product, as long as there is compliance, as appropriate, with the five unique provisions.”[2]
In the “Description of the Proposed Rule” the five unique provisions are clearly explained, and examples are provided (see the Proposed Rule for detail).[3] Once the proposed rule becomes effective (comments are due by December 30, 2009), combination product manufacturers will be required to provide more consistent and complete safety reports, and the FDA will have more information on combination products, upon which to make sound regulatory decisions about product safety and public health. In this era of rapidly developing medical technologies, this long-anticipated rule is making progress.
Sources:
[1] Federal Register/Vol. 74, No. 189/Thursday, October 1, 2009/Proposed Rules, pp. 50744-50758.
[2] Federal Register/Vol. 74, No. 189/Thursday, October 1, 2009/Proposed Rules, pp. 50750.
[3] http://edocket.access.gpo.gov/2009/pdf/E9-23519.pdf
Tuesday, November 10, 2009
Does the Federal Trade Commission want you to be Boring?
By: Jordan Mummau, CIS Compliance Associate
jordanmummau@cis-partners.com
Advertisement: Tired of being boring? Do you dread going to work on Mondays because you can’t ever answer the question ‘what did you do this weekend’ without revealing that your weekends consist of repainting action figures and building replica airplanes? Well worry no more, because we have a product for you; it’s called BOR-NO-MOR.
Testimonial: “I used to be so boring. Now with BOR-NO-MOR, I’m not only the coolest Cat in the office on Mondays, but Tuesday through Friday as well. I even crack jokes! Thanks BOR-NO-MOR!”
Disclaimer: “Results Not Typical.”
The Federal Trade Commission (FTC) has released its final revisions to the guidance it gives advertisers. These revisions detail how advertisers can keep their endorsements and testimonial advertisements within the confines of the FTC Act. According to the FTC’s website, the FTC “works for the consumer to prevent fraudulent, deceptive, and unfair business practices in the marketplace and to provide information to help consumers spot, stop, and avoid them.”[1]
With the new guidelines in place, advertisers who decide to run an advertisement or testimonial that features a consumer experience are now expected to clearly disclose the results that consumers typically expect from using the product being advertised. Taking this into consideration, the healthcare industry might no longer see advertisements and testimonials like the example of ‘BOR-NO-MOR’ illustrated above. The FTC is very specific in announcing that the advertiser and the person/entity endorsing the product must fully disclose their relationship. Material connections between these two parties must be exposed to the general consumer, including connections that consumers may not expect, such as offering someone money or free products to endorse your product.[2]
The guidelines specifically address celebrity endorsers. It is important to note that the guidelines implicitly state that “both advertisers and endorsers may be liable for false or unsubstantiated claims made in an endorsement – or for failure to disclose material connections between the advertiser and endorsers.”[3] The revised guidelines also outline regulations the FTC is trying to impose on “new-media” outlets, such as the internet; more specifically the FTC is targeting websites, bloggers, and social networking sites such as Facebook.[4]
Richard Cleland, Assistant Director of the Division of Advertising Practices at the FTC, said, “We were looking and seeing the significance of social media marketing in the 21st century and we thought it was time to explain the principles of transparency and truth in advertising and apply them to social media marketing.”[5]
For those of us who are interested in blogging, social networking sites, or having high-profile celebs endorse our products, the FTC may have just changed how viral marketing works forever, and our days of seeing advertisements, like the one for fictional “BOR-NO-MOR” may be numbered. The FTC is concerned about consumers and has implemented these guidelines in order to help them make better decisions about the products they use. Whether or not you agree with these new guidelines, it is difficult to criticize their intended purpose.
Sources:
[1] http://www.ftc.gov/bcp/edu/pubs/consumer/general/gen03.shtm
[2] http://www.ftc.gov/opa/2009/10/endortest.shtm
[3] http://www.ftc.gov/opa/2009/10/endortest.shtm
[4] http://news.cnet.com/8301-13577_3-10368064-36.html
[5] http://www.nytimes.com/2009/10/06/business/media/06adco.html
jordanmummau@cis-partners.com
Advertisement: Tired of being boring? Do you dread going to work on Mondays because you can’t ever answer the question ‘what did you do this weekend’ without revealing that your weekends consist of repainting action figures and building replica airplanes? Well worry no more, because we have a product for you; it’s called BOR-NO-MOR.
Testimonial: “I used to be so boring. Now with BOR-NO-MOR, I’m not only the coolest Cat in the office on Mondays, but Tuesday through Friday as well. I even crack jokes! Thanks BOR-NO-MOR!”
Disclaimer: “Results Not Typical.”
The Federal Trade Commission (FTC) has released its final revisions to the guidance it gives advertisers. These revisions detail how advertisers can keep their endorsements and testimonial advertisements within the confines of the FTC Act. According to the FTC’s website, the FTC “works for the consumer to prevent fraudulent, deceptive, and unfair business practices in the marketplace and to provide information to help consumers spot, stop, and avoid them.”[1]
With the new guidelines in place, advertisers who decide to run an advertisement or testimonial that features a consumer experience are now expected to clearly disclose the results that consumers typically expect from using the product being advertised. Taking this into consideration, the healthcare industry might no longer see advertisements and testimonials like the example of ‘BOR-NO-MOR’ illustrated above. The FTC is very specific in announcing that the advertiser and the person/entity endorsing the product must fully disclose their relationship. Material connections between these two parties must be exposed to the general consumer, including connections that consumers may not expect, such as offering someone money or free products to endorse your product.[2]
The guidelines specifically address celebrity endorsers. It is important to note that the guidelines implicitly state that “both advertisers and endorsers may be liable for false or unsubstantiated claims made in an endorsement – or for failure to disclose material connections between the advertiser and endorsers.”[3] The revised guidelines also outline regulations the FTC is trying to impose on “new-media” outlets, such as the internet; more specifically the FTC is targeting websites, bloggers, and social networking sites such as Facebook.[4]
Richard Cleland, Assistant Director of the Division of Advertising Practices at the FTC, said, “We were looking and seeing the significance of social media marketing in the 21st century and we thought it was time to explain the principles of transparency and truth in advertising and apply them to social media marketing.”[5]
For those of us who are interested in blogging, social networking sites, or having high-profile celebs endorse our products, the FTC may have just changed how viral marketing works forever, and our days of seeing advertisements, like the one for fictional “BOR-NO-MOR” may be numbered. The FTC is concerned about consumers and has implemented these guidelines in order to help them make better decisions about the products they use. Whether or not you agree with these new guidelines, it is difficult to criticize their intended purpose.
Sources:
[1] http://www.ftc.gov/bcp/edu/pubs/consumer/general/gen03.shtm
[2] http://www.ftc.gov/opa/2009/10/endortest.shtm
[3] http://www.ftc.gov/opa/2009/10/endortest.shtm
[4] http://news.cnet.com/8301-13577_3-10368064-36.html
[5] http://www.nytimes.com/2009/10/06/business/media/06adco.html
Monday, November 9, 2009
One Step Closer to Healthcare Reform
By: Katie Lapins, CIS Director of Small and Mid-Market Pharma
katielapins@cis-partners.com
The House of Representatives passed its version of healthcare reform on Saturday, November 7, 2009. As described, the purpose of H.R. 3962 is, “To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes.” With almost 2,000 pages, I think they covered “other purposes” pretty well.
If you have been following the various legislative proposals that have been presented, you’re probably wondering how H.R. 3962 differs from the original proposal, H.R. 3200. These changes are highlighted below in red.
* Note: The court injunction currently prohibits the publishing of AMP, and this legislation will not overrule the injunction.
Implementing these changes in as few as eight weeks may create an operational challenge for manufacturers, but based on my experience, the majority will figure it out. However, the changes will also pose a challenge for federal and state government agencies. Manufacturers usually only have one, maybe two systems to update, but the systems used by the various government agencies are different, as evidenced by the various formats of the Medicaid rebates required.
The next few steps we would anticipate in this process are for the Senate to vote, for the two bills to be “harmonized” and consolidated into one, and then for the bill to be presented to President Obama for approval. Depending on the timing of these activities, it appears that changes could be imminent for manufacturers.
CIS will continue to monitor all of the activities and will continue to post updates as they become available. To see the full version of H.R. 3962 click here.
katielapins@cis-partners.com
The House of Representatives passed its version of healthcare reform on Saturday, November 7, 2009. As described, the purpose of H.R. 3962 is, “To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes.” With almost 2,000 pages, I think they covered “other purposes” pretty well.
If you have been following the various legislative proposals that have been presented, you’re probably wondering how H.R. 3962 differs from the original proposal, H.R. 3200. These changes are highlighted below in red.
* Note: The court injunction currently prohibits the publishing of AMP, and this legislation will not overrule the injunction.Implementing these changes in as few as eight weeks may create an operational challenge for manufacturers, but based on my experience, the majority will figure it out. However, the changes will also pose a challenge for federal and state government agencies. Manufacturers usually only have one, maybe two systems to update, but the systems used by the various government agencies are different, as evidenced by the various formats of the Medicaid rebates required.
The next few steps we would anticipate in this process are for the Senate to vote, for the two bills to be “harmonized” and consolidated into one, and then for the bill to be presented to President Obama for approval. Depending on the timing of these activities, it appears that changes could be imminent for manufacturers.
CIS will continue to monitor all of the activities and will continue to post updates as they become available. To see the full version of H.R. 3962 click here.
Friday, November 6, 2009
Articles of the Week!
Courtesy of: Amanda Zanetti, CIS Compliance Associate
amandazanetti@cis-partners.com
1. Sweeping Health Care Plan Passes House
http://www.nytimes.com/2009/11/08/health/policy/08health.html?scp=2&sq=November+8+2009&st=nyt
2. House, Senate differ sharply on health care reform
http://www.cnn.com/2009/POLITICS/11/09/health.care.congress/index.html
3. Bill Clinton Presses Senators to Pass Health Bill
http://online.wsj.com/article/SB125786406778841165.html
4. Reid Considers Payroll Tax Hike for Health Care
http://www.foxnews.com/politics/2009/11/12/reid-eyes-payroll-tax-hike-health-care/
5. Health reform bill could boost drug companies
http://milwaukee.bizjournals.com/milwaukee/stories/2009/11/09/daily50.html
amandazanetti@cis-partners.com
1. Sweeping Health Care Plan Passes House
http://www.nytimes.com/2009/11/08/health/policy/08health.html?scp=2&sq=November+8+2009&st=nyt
2. House, Senate differ sharply on health care reform
http://www.cnn.com/2009/POLITICS/11/09/health.care.congress/index.html
3. Bill Clinton Presses Senators to Pass Health Bill
http://online.wsj.com/article/SB125786406778841165.html
4. Reid Considers Payroll Tax Hike for Health Care
http://www.foxnews.com/politics/2009/11/12/reid-eyes-payroll-tax-hike-health-care/
5. Health reform bill could boost drug companies
http://milwaukee.bizjournals.com/milwaukee/stories/2009/11/09/daily50.html
Thursday, November 5, 2009
Texas Medicaid Reporting Requirements
By: Jessica Ebert, CIS Compliance Associate
jessicaebert@cis-partners.com
Have you received a request from the Texas Vendor Drug Program (VDP) that looks something like this?
If you have products listed in the Texas Drug Code Index (TDCI) for Medicaid, chances are you’ve seen this before. You are responsible for keeping the Texas VDP notified of any price changes, NDC changes, and terminated products within 15 days of the change. As you know, it’s important that you report information that accurately reflects the market prices paid within the class of trade for which pricing information is requested. For products that are already listed in the TDCI, Average Manufacturer Price (AMP) reporting is required every quarter, and can be sent by either a text email or on a disk to Jerry.Rodriguez@hhsc.state.tx.us.
If you want to add a new or reformulated product to the TDCI, you must apply for the addition by completing the questionnaire provided by the Texas Health and Human Services Commission. The questionnaire is only to be used for new and reformulated products. If you have a valid rebate agreement under the Social Security Act §1927 you can apply for the addition of a drug that is not currently listed in the Texas Drug Code Index (TDCI). The form must be completed in full and requests the following:
If an NDC number for a product has changed without a reformulation, you do not need to complete a new questionnaire. However, you must submit the information on your company’s letterhead with the old NDC number (with last lot expiration date listed), the new NDC number (when available in the marketplace) and the current net pricing for that product. This also applies to terminated products; you must submit the NDC number and the last lot expiration date on your company letterhead.
Questionnaires should be sent to:
HHSC
Attn: VDP/Formulary H630
11209 Metric Blvd, Bldg H
Austin, TX 78758
After the questionnaire has been submitted, it will be reviewed and evaluated by the Commission. The Commission determines if there is a need for the product on the TDCI, as well as a need for appropriate restrictions.
Some of the key factors that the Commission looks at when reviewing applications are the:
All inquiries regarding the questionnaire and revisions are to be directed to:
Vendor Drug Program-FormularyMC: H630
Health & Human Services Commission
PO Box 85200
Austin, Texas 78708-5200
Vendor Drug Program-Formulary MC: H630
Health & Human Services Commission
11209 Metric Blvd, Bldg H
Austin, Texas 78758
Sources:
Health and Human Services Commission, Chapter 35. Pharmacy Services, Subchapter H. Texas Drug Code Index – Addition, Retention, and Deletion of Drugs
http://www.hhsc.state.tx.us/hcf/vdp/RULES042408.pdf
Texas Health and Human Services Commission Questionnaire
http://www.hhsc.state.tx.us/contract/52904324/RFPDocs/AppK.pdf
jessicaebert@cis-partners.com
Have you received a request from the Texas Vendor Drug Program (VDP) that looks something like this?
“Please send us current net pricing after all charge backs, discounts and
rebates to wholesalers/distributors or pharmacies are applied, other than
commercially reasonable prompt pay discounts for this product, and any other
products under your label that may have had a recent price change. If possible,
please attach to an e-mail, with reply to all.”
If you have products listed in the Texas Drug Code Index (TDCI) for Medicaid, chances are you’ve seen this before. You are responsible for keeping the Texas VDP notified of any price changes, NDC changes, and terminated products within 15 days of the change. As you know, it’s important that you report information that accurately reflects the market prices paid within the class of trade for which pricing information is requested. For products that are already listed in the TDCI, Average Manufacturer Price (AMP) reporting is required every quarter, and can be sent by either a text email or on a disk to Jerry.Rodriguez@hhsc.state.tx.us.
If you want to add a new or reformulated product to the TDCI, you must apply for the addition by completing the questionnaire provided by the Texas Health and Human Services Commission. The questionnaire is only to be used for new and reformulated products. If you have a valid rebate agreement under the Social Security Act §1927 you can apply for the addition of a drug that is not currently listed in the Texas Drug Code Index (TDCI). The form must be completed in full and requests the following:
- Full drug description, including dosage form, maximum and recommended daily dose, ingredients, shelf life, estimated average and maximum duration of therapy, orange book rating, etc.
- Specific pricing information, including Average Wholesale Price to pharmacy (AWP), AMP, price to wholesaler and/or distributor, direct price to pharmacy, central purchase price to chain (such as warehouse price), and institutional or other contract price. You may also provide a range of prices if you do not sell at a single price and wish to disclose only the lowest and highest prices. Be sure that you do not leave any pricing areas blank, as this will be interpreted that you DO NOT sell the product to entities in that category.
- Companies to whom pricing information is reported (e.g., Red Book, Medi-Span)
- Attach a listing of distributors, re-packagers, or re-labelers, other than full-service drug wholesalers, that you sell your product to who in turn sell your product to retail trade under your NDC number.
- Attach a copy of your Vendor Liability Insurance, unless you have previously submitted it.
- List the date that your drug is available through wholesalers.
- The name and address of the firm, manufacturer, and government affairs persons covering the Texas area (if applicable).
- Submit a copy of the FDA letter of approval of the NDA or ANDA for your product. If not applicable, submit a copy of the FDA letter for approval for marketing.
- Indicate the DESI classification of the product.
If an NDC number for a product has changed without a reformulation, you do not need to complete a new questionnaire. However, you must submit the information on your company’s letterhead with the old NDC number (with last lot expiration date listed), the new NDC number (when available in the marketplace) and the current net pricing for that product. This also applies to terminated products; you must submit the NDC number and the last lot expiration date on your company letterhead.
Questionnaires should be sent to:
HHSC
Attn: VDP/Formulary H630
11209 Metric Blvd, Bldg H
Austin, TX 78758
After the questionnaire has been submitted, it will be reviewed and evaluated by the Commission. The Commission determines if there is a need for the product on the TDCI, as well as a need for appropriate restrictions.
Some of the key factors that the Commission looks at when reviewing applications are the:
- “Expansion of the prescriber’s armamentarium by a new drug or an additional multisource drug
- Predominant use of the drug in an outpatient setting
- Cost of the drug to pharmacies compared to the wholesale estimated acquisition cost (WEAC), or direct estimated acquisition costs (DEAC) listed in Redbook”, the AMP, or other generically equivalent products
All inquiries regarding the questionnaire and revisions are to be directed to:
Vendor Drug Program-FormularyMC: H630
Health & Human Services Commission
PO Box 85200
Austin, Texas 78708-5200
Vendor Drug Program-Formulary MC: H630
Health & Human Services Commission
11209 Metric Blvd, Bldg H
Austin, Texas 78758
Sources:
Health and Human Services Commission, Chapter 35. Pharmacy Services, Subchapter H. Texas Drug Code Index – Addition, Retention, and Deletion of Drugs
http://www.hhsc.state.tx.us/hcf/vdp/RULES042408.pdf
Texas Health and Human Services Commission Questionnaire
http://www.hhsc.state.tx.us/contract/52904324/RFPDocs/AppK.pdf
Wednesday, November 4, 2009
Upcoming PCF Conference
CIS will be exhibiting at PCF’s Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum Conference!
http://www.pharmacongress.com/
When: Wednesday, November 11th - Friday, November 13th
Where: JW Marriott, Washington D.C.
Stop by our booth: #202!
Please click here for conference information.
Below are some past blog articles relevant to Commercial Compliance:
Assessments versus Audits
By: Judy Fox
Paper Compliance Just Isn’t Enough
By: Meredith Taylor
SOPs: Periodic Review and Process Improvement
By: Suma Kallurkar
*
http://www.pharmacongress.com/
When: Wednesday, November 11th - Friday, November 13th
Where: JW Marriott, Washington D.C.
Stop by our booth: #202!
Please click here for conference information.
Below are some past blog articles relevant to Commercial Compliance:
Assessments versus Audits
By: Judy Fox
Paper Compliance Just Isn’t Enough
By: Meredith Taylor
SOPs: Periodic Review and Process Improvement
By: Suma Kallurkar
*
Monday, November 2, 2009
A Quick Look at the 340B Program Improvement and Integrity Act of 2009
By Matt Hotz, CIS Senior Associate
matthotz@cis-partners.com
The 340B Program Improvement and Integrity Act of 2009, known as S.1239 [1] in the Senate, would bring some significant changes to the 340B program if enacted. Sponsored [2] by Sen. Jeff Bingaman [D, NM], the bill has been referred to the Senate Committee on Health, Labor, Education, and Pensions for review.
To familiarize our clients and blog readers with the bill and the changes it could bring, CIS has prepared a summary of the proposed changes and what these changes could mean to you.
Key changes in the bill include:
- More Covered Entities – Several new types of facilities, including children’s hospitals, rural referral centers, and critical access hospitals, would be eligible to participate as covered entities in the program.
- Broader Coverage – Discounts would be expanded to cover drugs prescribed in both inpatient and outpatient settings. Currently, the 340B program only covers drugs prescribed in an outpatient setting.
- Integrity and Program Management Improvements – More administrative structure will be implemented on the management of the program, including heightened scrutiny and oversight on manufacturers as well as guidance regarding calculations and restatements.
Key components to improve the management and integrity of the program include:
- Pricing data submitted by manufacturers will be more closely scrutinized.
- Recalculations and resubmissions may be required of manufacturers in cases when covered entities are overcharged.
- The Office of Pharmacy Affairs (OPA) will be authorized to establish standard methodologies for calculating prices and to develop a process for handling recalculations and resubmissions.
- Selective proactive audits of manufacturers and wholesalers may be conducted.
- Sanctions will be imposed on manufacturers and wholesalers in cases of knowing and intentional overcharging.
- Sanctions will be imposed on covered entities in cases of knowing and intentional fraud, including the possibility of removal from the 340B program.
Potential impact for manufacturers could include:
- Manufacturers may have to revise their PHS policies and procedures to match the standardized methodologies that could be established by the bill, potentially increasing their administrative costs.
- Manufacturers may also need to calculate two Average Manufacturer Prices (AMPs), one for Medicaid and one for the PHS program. This is one of the biggest areas of uncertainty – there are pending legislative changes regarding AMP calculation on the Medicaid side as well.
- Administrative costs may increase in cases where recalculations and/or resubmissions are required.
- Audit risk may increase with more oversight and selective proactive audits.
- Financial exposure may increase with the establishment of sanctions for fraud.
- Revenues may decrease as discounts are expanded to include drugs prescribed in both inpatient and outpatient settings.
A slightly different version of this bill (HR444) is circulating in the House of Representatives [3], but the two bills are very similar in both content and their implications for the industry. The main points of both bills are covered in this primer.
CIS continues to monitor and analyze both the House and Senate bills and related proposed legislation. If you want to know more about this issue, what it could mean to pharmaceutical manufacturers, and what you can do during this interim phase, please contact CIS.
Sources:
[1] S. 1239: http://thomas.loc.gov/home/gpoxmlc111/s1239_is.xml
[2] Press Release from the Office of Sen. Jeff Bingaman regarding S. 1239: http://bingaman.senate.gov/news/20090611-02.cfm
[3] H.R. 444: http://thomas.loc.gov/home/gpoxmlc111/h444_ih.xml
Friday, October 30, 2009
Articles of the Week!
Courtesy of: Jordan Mummau, CIS Compliance Associate
jordanmummau@cis-partners.com
1) When FDA Fails to Follow-Up on Rapid Drug
http://blogs.wsj.com/health/2009/10/26/when-fda-fails-to-follow-up-on-rapid-drug-approvals/
2) Industry Years Behind on Testing Approved Drugs
http://www.nytimes.com/2009/10/27/health/policy/27fda.html?_r=1&ref=health
3) Kids on Psych Drugs Have Alarming Weight Gain.
http://www.msnbc.msn.com/id/33494879/ns/health-mental_health/
4) US Swine Flu Vaccine Outlook Improving, CDC Says
http://news.yahoo.com/s/ap/20091028/ap_on_he_me/us_med_swine_flu
5) House Democrats Prepare to Unveil Health Bill http://news.yahoo.com/s/ap/20091028/ap_on_bi_ge/us_health_care_overhaul;_ylt=AhZoRmwe3EwJkqPVZdQAeyTVJRIF;_ylu=X3oDMTJvM2JuYmtrBGFzc2V0A2FwLzIwMDkxMDI4L3VzX2hlYWx0aF9jYXJlX292ZXJoYXVsBGNwb3MDMQRwb3MDMgRzZWMDeW5fdG9wX3N0b3J5BHNsawNob3VzZWRlbW9jcmE-
jordanmummau@cis-partners.com
1) When FDA Fails to Follow-Up on Rapid Drug
http://blogs.wsj.com/health/2009/10/26/when-fda-fails-to-follow-up-on-rapid-drug-approvals/
2) Industry Years Behind on Testing Approved Drugs
http://www.nytimes.com/2009/10/27/health/policy/27fda.html?_r=1&ref=health
3) Kids on Psych Drugs Have Alarming Weight Gain.
http://www.msnbc.msn.com/id/33494879/ns/health-mental_health/
4) US Swine Flu Vaccine Outlook Improving, CDC Says
http://news.yahoo.com/s/ap/20091028/ap_on_he_me/us_med_swine_flu
5) House Democrats Prepare to Unveil Health Bill http://news.yahoo.com/s/ap/20091028/ap_on_bi_ge/us_health_care_overhaul;_ylt=AhZoRmwe3EwJkqPVZdQAeyTVJRIF;_ylu=X3oDMTJvM2JuYmtrBGFzc2V0A2FwLzIwMDkxMDI4L3VzX2hlYWx0aF9jYXJlX292ZXJoYXVsBGNwb3MDMQRwb3MDMgRzZWMDeW5fdG9wX3N0b3J5BHNsawNob3VzZWRlbW9jcmE-
Thursday, October 29, 2009
Department of Veterans Affairs Dear Manufacturer Letter - October 16, 2009
By: Dave Rice, CIS Director of Federal Contracting – daverice@cis-partners.com,
and John Avicolli, CIS Project Manager – johnavicolli@cis-partners.com
Dear Colleagues and Friends,
As you know, the Department of Veterans Affairs issued a Dear Manufacturer letter on October 16, 2009, and the “GP Geeks” at CIS would like to share our thoughts, opinions and analysis on the implications of this letter, as it relates to Non-FAMP reporting in accordance with Section 603 of Public Law 102-585 (Veteran’s Health Care Act of 1992; 38 U.S.C. 8126), as well as provide some key take-away points.
The U.S. Bureau of Labor Statistics indicates the percent change to the Consumer Price Index for All Urban Consumers (CPI-U) is -1.28%. As such, a zero (0) will be used as the CPI-U for the Federal Ceiling Price (FCP) calculations due on November 16, 2009.
The permanent FSS contract price for dual priced manufacturers is the September 30, 2009 price charged to other, non-“Big Four,” government agencies.
The lower of the 2009 annual Non-FAMP calculation and the 2010 FSS Price Cap will become the 2010 FCP.
Manufacturers must back out TRICARE sales/units that went to wholesalers/merchant middlemen at Wholesale Acquisition Cost (WAC). Direct sales to retail chains/retail pharmacies are not included in the calculation as they are not part of the merchant middleman transaction.
The periods in play for the application of backing out TRICARE sales/units are as follows: 2nd quarter 2008, 3rd quarter 2008, 4th quarter 2008, and 1st quarter 2009. Tricare Retail Pharmacy (TRRx) utilization is captured based on the due date (not the paid date). As the due date for payments is 70 days after the invoice date, this creates a two quarter lag.[1]
Sub-ceiling contract transactions that are executed through the 340B Prime Vendor are accordingly considered 340B transactions and are excludable from Non-FAMP calculations.
Sales of specific inpatient covered drugs to disproportionate share hospitals at Sec. 602 prices may be excluded from Non-FAMP if manufacturers have obtained a “hold harmless” letter from the VA.
It should be noted that manufacturers DO NOT have to re-perform Non-FAMP calculations to reflect TRICARE usage for prior periods. The Secretary of the VA has issued a re-filing waiver that is applicable to every manufacturer regardless of when or whether the manufacturer actually paid DoD refunds/rebates for TRICARE script purchases during this timeframe.
We recommend that all manufacturers submit their calculations electronically to Pharmacy Benefits Management (PBM) at the following email address: NonFamp@va.gov.
The PBM will review Non-FAMP submissions and calculate changes in Non-FAMP, additional discounts, and 2010 FCP. Upon conclusion, the PBM will electronically send its calculations back to the manufacturers.
We highly recommend that all manufacturers review the returned files from the PBM for accuracy and completeness. If there are any discrepancies with the PBM’s calculations, manufacturers must contact the PBM (preferably by email) within five working days. If the manufacturer does not question the consistency of the calculations, this will constitute acceptance of the VA’s FCP calculations.
You can find a copy of the VA's October 16, 2009 Dear Manufacturer Letter on the GP PCX (http://gp.cis-pcx.com/) under "Hot Topics." To register for a 30 day free trial of the GP PCX, please click here: http://gp.cis-pcx.com/register/
Additional source:
[1] Process and Procedures Guide – Retail Utilization Refunds and Voluntary Agreements for Uniform Formulary Placement: http://www.tricare.mil/pharm_mfg/downloads/PROCESS%20AND%20PROCEDURES%20GUIDE_040209.pdf
and John Avicolli, CIS Project Manager – johnavicolli@cis-partners.com
Dear Colleagues and Friends,
As you know, the Department of Veterans Affairs issued a Dear Manufacturer letter on October 16, 2009, and the “GP Geeks” at CIS would like to share our thoughts, opinions and analysis on the implications of this letter, as it relates to Non-FAMP reporting in accordance with Section 603 of Public Law 102-585 (Veteran’s Health Care Act of 1992; 38 U.S.C. 8126), as well as provide some key take-away points.
The U.S. Bureau of Labor Statistics indicates the percent change to the Consumer Price Index for All Urban Consumers (CPI-U) is -1.28%. As such, a zero (0) will be used as the CPI-U for the Federal Ceiling Price (FCP) calculations due on November 16, 2009.
The permanent FSS contract price for dual priced manufacturers is the September 30, 2009 price charged to other, non-“Big Four,” government agencies.
The lower of the 2009 annual Non-FAMP calculation and the 2010 FSS Price Cap will become the 2010 FCP.
Manufacturers must back out TRICARE sales/units that went to wholesalers/merchant middlemen at Wholesale Acquisition Cost (WAC). Direct sales to retail chains/retail pharmacies are not included in the calculation as they are not part of the merchant middleman transaction.
The periods in play for the application of backing out TRICARE sales/units are as follows: 2nd quarter 2008, 3rd quarter 2008, 4th quarter 2008, and 1st quarter 2009. Tricare Retail Pharmacy (TRRx) utilization is captured based on the due date (not the paid date). As the due date for payments is 70 days after the invoice date, this creates a two quarter lag.[1]
Sub-ceiling contract transactions that are executed through the 340B Prime Vendor are accordingly considered 340B transactions and are excludable from Non-FAMP calculations.
Sales of specific inpatient covered drugs to disproportionate share hospitals at Sec. 602 prices may be excluded from Non-FAMP if manufacturers have obtained a “hold harmless” letter from the VA.
It should be noted that manufacturers DO NOT have to re-perform Non-FAMP calculations to reflect TRICARE usage for prior periods. The Secretary of the VA has issued a re-filing waiver that is applicable to every manufacturer regardless of when or whether the manufacturer actually paid DoD refunds/rebates for TRICARE script purchases during this timeframe.
We recommend that all manufacturers submit their calculations electronically to Pharmacy Benefits Management (PBM) at the following email address: NonFamp@va.gov.
The PBM will review Non-FAMP submissions and calculate changes in Non-FAMP, additional discounts, and 2010 FCP. Upon conclusion, the PBM will electronically send its calculations back to the manufacturers.
We highly recommend that all manufacturers review the returned files from the PBM for accuracy and completeness. If there are any discrepancies with the PBM’s calculations, manufacturers must contact the PBM (preferably by email) within five working days. If the manufacturer does not question the consistency of the calculations, this will constitute acceptance of the VA’s FCP calculations.
You can find a copy of the VA's October 16, 2009 Dear Manufacturer Letter on the GP PCX (http://gp.cis-pcx.com/) under "Hot Topics." To register for a 30 day free trial of the GP PCX, please click here: http://gp.cis-pcx.com/register/
Additional source:
[1] Process and Procedures Guide – Retail Utilization Refunds and Voluntary Agreements for Uniform Formulary Placement: http://www.tricare.mil/pharm_mfg/downloads/PROCESS%20AND%20PROCEDURES%20GUIDE_040209.pdf
Wednesday, October 28, 2009
Could This Be The Future Of Smoking?
By: Aimee Hummel, CIS Compliance Manager
aimeehummel@cis-partners.com
I was driving into work the other day when I heard a commercial for electronic cigarettes. The thought of an electronic cigarette sounded ridiculous, but as I listened, they caught my interest. They claim that they are a safer alternative to regular cigarettes. The commercial made them seem like a no brainer for those trying to quit smoking. They do not smoke like traditional cigarettes so you can use them in public places, they do not smell bad, and they say they are not as harmful. And in this case, they were offering a free trial. It just seemed too good to be true, and it might be…
The FDA released a warning on July 22, 2009 regarding the health risks associated with electronic cigarettes. There are many concerns about the use of these new “e-Cigarettes,” mostly due to the fact that they are not FDA-regulated. Currently, FDA scientists are testing the product to determine the potential health risks.
E-Cigarettes offer smokers nicotine without the tobacco or smoke. The e-Cigarette is a small cylinder that looks like a regular, or “analog,” cigarette. It has a battery operated heating element that vaporizes the liquid in the mouthpiece cartridge which contains nicotine. Users exhale a vapor that looks like smoke but without cancer causing tar and carbon monoxide, or so they say. E-Cigarettes are offered in varying levels of nicotine just like regular cigarettes, for example, light and ultra light. The whole idea is that they simulate real smoking, unlike other quitting devices such as patches or gum. This new technology is appealing to smokers who are trying to quit because it allows them to “smoke” indoors, around friends, and even in bars and restaurants. There is no need for ash trays and there is no smell; therefore, some business owners actually support it as an unobtrusive way to help smokers quit.
Since the e-Cigarettes are not FDA-regulated, it is not known if there are any harmful effects, or if they are in fact safer than regular cigarettes. So far the FDA has taken the following measures to protect the public: it has been fighting in court, seizing shipments into the US, and conducting testing to analyze the safety of e-Cigarettes. The FDA has found that e-Cigarettes generate cancer causing chemicals and other impurities, including low levels of diethylene glycol, a toxic component of antifreeze. The FDA believes that e-Cigarettes should be regulated as a new drug product, just like other nicotine products, such as patches and inhalers, which are only available by prescription. In order for e-Cigarettes to be regulated they will need to undergo clinical trials to show that they do indeed help people quit. Apparently, the suppliers are in the process of doing this, so only time will tell. In the meantime, healthcare professionals are advised to report serious adverse events or product quality problems associated with the use of e-Cigarettes to the FDA through the MedWatch Program.
In addition to health and efficacy concerns, it is also feared that since there are no age restrictions on electronic cigarettes, and they are distributed online and in malls, that teens will start to use them. They are offered in a variety of flavors such as chocolate, strawberry, and mint, which were recently banned in regular cigarettes because they were believed to increase tobacco use in young people.
Those who support e-Cigarettes, including some doctors, believe that this is the future of smoking. They believe that e-Cigarettes could help save the 400,000 Americans who die each year from tobacco, as well as the 48,000 who die each year from second hand smoke, and the 700 people who die in fires caused by smoking.
As you can see, there are both good and bad claims regarding e-Cigarettes, and until they are regulated we will not know if they are safer or better than traditional cigarettes. If indeed they are proven to be safe, this will be a huge development against cancer and other smoking related illnesses.
Sources:
1) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173222.htm
2) http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm173401.htm
3) http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm
4) http://www.dailyherald.com/story/?id=327689
aimeehummel@cis-partners.com
I was driving into work the other day when I heard a commercial for electronic cigarettes. The thought of an electronic cigarette sounded ridiculous, but as I listened, they caught my interest. They claim that they are a safer alternative to regular cigarettes. The commercial made them seem like a no brainer for those trying to quit smoking. They do not smoke like traditional cigarettes so you can use them in public places, they do not smell bad, and they say they are not as harmful. And in this case, they were offering a free trial. It just seemed too good to be true, and it might be…
The FDA released a warning on July 22, 2009 regarding the health risks associated with electronic cigarettes. There are many concerns about the use of these new “e-Cigarettes,” mostly due to the fact that they are not FDA-regulated. Currently, FDA scientists are testing the product to determine the potential health risks.
E-Cigarettes offer smokers nicotine without the tobacco or smoke. The e-Cigarette is a small cylinder that looks like a regular, or “analog,” cigarette. It has a battery operated heating element that vaporizes the liquid in the mouthpiece cartridge which contains nicotine. Users exhale a vapor that looks like smoke but without cancer causing tar and carbon monoxide, or so they say. E-Cigarettes are offered in varying levels of nicotine just like regular cigarettes, for example, light and ultra light. The whole idea is that they simulate real smoking, unlike other quitting devices such as patches or gum. This new technology is appealing to smokers who are trying to quit because it allows them to “smoke” indoors, around friends, and even in bars and restaurants. There is no need for ash trays and there is no smell; therefore, some business owners actually support it as an unobtrusive way to help smokers quit.
Since the e-Cigarettes are not FDA-regulated, it is not known if there are any harmful effects, or if they are in fact safer than regular cigarettes. So far the FDA has taken the following measures to protect the public: it has been fighting in court, seizing shipments into the US, and conducting testing to analyze the safety of e-Cigarettes. The FDA has found that e-Cigarettes generate cancer causing chemicals and other impurities, including low levels of diethylene glycol, a toxic component of antifreeze. The FDA believes that e-Cigarettes should be regulated as a new drug product, just like other nicotine products, such as patches and inhalers, which are only available by prescription. In order for e-Cigarettes to be regulated they will need to undergo clinical trials to show that they do indeed help people quit. Apparently, the suppliers are in the process of doing this, so only time will tell. In the meantime, healthcare professionals are advised to report serious adverse events or product quality problems associated with the use of e-Cigarettes to the FDA through the MedWatch Program.
In addition to health and efficacy concerns, it is also feared that since there are no age restrictions on electronic cigarettes, and they are distributed online and in malls, that teens will start to use them. They are offered in a variety of flavors such as chocolate, strawberry, and mint, which were recently banned in regular cigarettes because they were believed to increase tobacco use in young people.
Those who support e-Cigarettes, including some doctors, believe that this is the future of smoking. They believe that e-Cigarettes could help save the 400,000 Americans who die each year from tobacco, as well as the 48,000 who die each year from second hand smoke, and the 700 people who die in fires caused by smoking.
As you can see, there are both good and bad claims regarding e-Cigarettes, and until they are regulated we will not know if they are safer or better than traditional cigarettes. If indeed they are proven to be safe, this will be a huge development against cancer and other smoking related illnesses.
Sources:
1) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173222.htm
2) http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm173401.htm
3) http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm
4) http://www.dailyherald.com/story/?id=327689
Monday, October 26, 2009
Who’s Watching the Doc?
By: Jon Dellaquila, CIS Compliance Manager
jondellaquila@cis-partners.com
Sponsor companies, the company supporting a clinical trial, within the pharmaceutical industry are constantly under the watchful eyes of government agencies responsible for the safety and well-being of the general public. These companies are expected to adhere to the highest ethical standards and have various procedures in place to support their activities. However, when a company is inspected by a government agency and found to have violated a specific regulation or law, the information is made public and garners significant media attention.
When companies are cited during an inspection and receive a warning letter (such as a 483), it is in their best interest to reply in a timely manner. In the event that a timeline for resolving compliance issues mandated by the FDA is not met by the sponsor company, the FDA has the right to enforce daily monetary fines against the company. [1] Sponsor companies are in complete control of their manufacturing and drug development processes, making them solely responsible for the products they produce. However, once clinical trials begin, an additional variable, the role of the investigator, becomes significant. Although companies have procedures in place to ensure they work with doctors who have no previous criminal activity, it is imperative that companies also have procedures in place to provide the proper oversight regarding investigator behavior.
An October 22 article published in the Wall Street Journal titled ‘FDA Slow to Debar Doctors Who Commit Crimes, Report Says’ should raise some eyebrows in the pharmaceutical community. In the report, it states that the FDA took 11 years to debar a physician who had been convicted of 53 counts of criminal offense, including concealing the attempted suicide of a clinical-trial patient and prescribing a drug without a license.[2] The government watchdog report also stated it takes the FDA on average, four years to debar a physician. Although the FDA does its best to oversee doctors, it is ultimately the responsibility of the sponsor company supporting the trial. Since the FDA debarment process is four years on average, it is imperative the sponsor companies ensure their clinical trial sites are being adequately monitored. The FDA does not have the resources to monitor every doctor on a day-to-day basis. Sponsor companies must do their part to ensure trials are not compromised and avoid any unnecessary issues or monetary penalties.
The FDA is working diligently to create positions to provide physician oversight. However, they are limited in their abilities to debar physicians. In fact, physicians who are barred from participating in a drug trial still have the ability to participate in a medical device trial and vice versa. [2] This further emphasizes the need for sponsor companies to ensure that their monitoring activities are adequate and any identifiable issues are being resolved. For instance, if a sponsor company lacked site oversight and a particular physician was found to have acted unethically and was debarred, the data gathered from that site for a trial would not be valid. This could significantly impact trial endpoints resulting in severe financial losses.
Time and time again it has become evident that it is in the best interest of the sponsor companies to do their due diligence and ensure they have the correct procedures and preventative measures in place to minimize compliance risks. Besides the obvious financial savings, it would also eliminate a lot of unnecessary headaches among employees. One could say, it literally pays to be inspection ready.
Sources:
[1] http://findarticles.com/p/articles/mi_qa5351/is_200006/ai_n21457185/
[2] http://online.wsj.com/article/SB125622345164801405.html
jondellaquila@cis-partners.com
Sponsor companies, the company supporting a clinical trial, within the pharmaceutical industry are constantly under the watchful eyes of government agencies responsible for the safety and well-being of the general public. These companies are expected to adhere to the highest ethical standards and have various procedures in place to support their activities. However, when a company is inspected by a government agency and found to have violated a specific regulation or law, the information is made public and garners significant media attention.
When companies are cited during an inspection and receive a warning letter (such as a 483), it is in their best interest to reply in a timely manner. In the event that a timeline for resolving compliance issues mandated by the FDA is not met by the sponsor company, the FDA has the right to enforce daily monetary fines against the company. [1] Sponsor companies are in complete control of their manufacturing and drug development processes, making them solely responsible for the products they produce. However, once clinical trials begin, an additional variable, the role of the investigator, becomes significant. Although companies have procedures in place to ensure they work with doctors who have no previous criminal activity, it is imperative that companies also have procedures in place to provide the proper oversight regarding investigator behavior.
An October 22 article published in the Wall Street Journal titled ‘FDA Slow to Debar Doctors Who Commit Crimes, Report Says’ should raise some eyebrows in the pharmaceutical community. In the report, it states that the FDA took 11 years to debar a physician who had been convicted of 53 counts of criminal offense, including concealing the attempted suicide of a clinical-trial patient and prescribing a drug without a license.[2] The government watchdog report also stated it takes the FDA on average, four years to debar a physician. Although the FDA does its best to oversee doctors, it is ultimately the responsibility of the sponsor company supporting the trial. Since the FDA debarment process is four years on average, it is imperative the sponsor companies ensure their clinical trial sites are being adequately monitored. The FDA does not have the resources to monitor every doctor on a day-to-day basis. Sponsor companies must do their part to ensure trials are not compromised and avoid any unnecessary issues or monetary penalties.
The FDA is working diligently to create positions to provide physician oversight. However, they are limited in their abilities to debar physicians. In fact, physicians who are barred from participating in a drug trial still have the ability to participate in a medical device trial and vice versa. [2] This further emphasizes the need for sponsor companies to ensure that their monitoring activities are adequate and any identifiable issues are being resolved. For instance, if a sponsor company lacked site oversight and a particular physician was found to have acted unethically and was debarred, the data gathered from that site for a trial would not be valid. This could significantly impact trial endpoints resulting in severe financial losses.
Time and time again it has become evident that it is in the best interest of the sponsor companies to do their due diligence and ensure they have the correct procedures and preventative measures in place to minimize compliance risks. Besides the obvious financial savings, it would also eliminate a lot of unnecessary headaches among employees. One could say, it literally pays to be inspection ready.
Sources:
[1] http://findarticles.com/p/articles/mi_qa5351/is_200006/ai_n21457185/
[2] http://online.wsj.com/article/SB125622345164801405.html
Friday, October 23, 2009
Articles of the Week!
Courtesy of: Debbe Saez, CIS Senior Compliance Manager
debbesaez@cis-partners.com
1) Vote on Medicare Payment Cuts Divides Democrats
http://online.wsj.com/article/SB125613897074399103.html
2) Key senators may rebuff Obama on health care
http://news.yahoo.com/s/ap/20091022/ap_on_go_co/us_health_care_obama_s_challenge
3) F.D.A. Lags in Banning Researchers After Fraud
http://www.nytimes.com/2009/10/22/health/policy/22fda.html?_r=1&ref=health
4) RNAi-Boom or Bust?
http://www.pharmalive.com/magazines/randd/view.cfm?articleID=8247
5) Medical marijuana policy move sparks cautious optimism
http://www.cnn.com/2009/HEALTH/10/21/medical.marijuana.policy/index.html
*
debbesaez@cis-partners.com
1) Vote on Medicare Payment Cuts Divides Democrats
http://online.wsj.com/article/SB125613897074399103.html
2) Key senators may rebuff Obama on health care
http://news.yahoo.com/s/ap/20091022/ap_on_go_co/us_health_care_obama_s_challenge
3) F.D.A. Lags in Banning Researchers After Fraud
http://www.nytimes.com/2009/10/22/health/policy/22fda.html?_r=1&ref=health
4) RNAi-Boom or Bust?
http://www.pharmalive.com/magazines/randd/view.cfm?articleID=8247
5) Medical marijuana policy move sparks cautious optimism
http://www.cnn.com/2009/HEALTH/10/21/medical.marijuana.policy/index.html
*
Thursday, October 22, 2009
SURPRISE! : How’s a Manufacturer to Accrue for Unpredictable Medicaid Invoicing Practices?
By Karen Agama, CIS Compliance Consultant
karenagama@cis-partners.com
One quarter, a state bills for a little over $3,500.00. The next, over $40,000.00!! All the summary level variance tests look fine, and wondering how this can possibly be, you ask the state for claims level detail. Not seeing anything amiss with the numbers, you call your state contact for an explanation of the 1,000+% increase. Your end of the conversation sounds something like, “Oh, I see…the state withholds reimbursement to its providers when it runs out of budget money at its fiscal year end, then catches up when the coffers are replenished in the new budget year. The state has withheld reimbursement for six months? Oh, yes. I do see service dates in the detailed data that correspond with that period. Thank you for the explanation.” Now, you have to prepare your message to the higher ups in your company to help them understand how this can happen when dealing with Medicaid programs and why the accrual projections did not set aside nearly enough of your company’s budget money for the payment that’s about to hit the books.
How can this happen? Is this practice allowed? If this scenario can occur, what else could pop up? Can manufacturers ever know if a shock like this is lurking around the proverbial bend?
Since the Medicaid Drug Rebate Program (MDRP) was instituted with the Omnibus Budget Reconciliation Act of 1990 (OBRA ’90), no restriction on the amount of time for which the states could seek retroactive rebates has ever been imposed. A manufacturer could therefore expect to potentially be invoiced for claims, or receive adjustments to prior claims invoiced, going all the way back to 1991. Fortunately, the states are generally more current in their submissions, but it is possible and allowable for states to present manufacturers with the scenario described above, and with smatterings of “found” claims from prior periods in the current period’s invoice totals. It works the other way, too, with states reversing claims from prior periods that have been found to be ineligible for the MDRP.
A second scenario relates to the submission of congested J-Code (HCPCS) claims. Since January 2008, states have been required to submit utilization data for all single-source, and at least the top 20 multiple-source, physician-administered drugs, but identifying which multiple-source product’s NDC is associated with an HCPCS claim has historically been problematic. To facilitate state submission of these claims, an NDC to HCPCS crosswalk table was established (see https://www.dmepdac.com/crosswalk/index.html), and physicians are required to report the NDCs of the products used in each procedure. With these resources in place, the Deficit Reduction Act of 2005 (DRA) prohibits the states from receiving federal participation related to physician-administered drugs unless they submit claims as required.
State governments are not always adequately funded or resourced to move quickly on these types of mandates, and may either outsource the work to a qualified vendor or update their internal systems and processes. In either case, creating multiple-source crosswalks can be slow and laborious, and for process-specific reasons, the result can be multiple quarters submitted within a single invoice processing cycle.
Are manufacturers then allowed to rebate at the rate that was in effect at the time of the original claims service? In the J-Code scenario, each quarter’s claims are typically invoiced separately, even though they are all sent at one time, so the rebate is calculated at the period-specific rate. Where the budget causes the backlog, there is no provision in the law for making any such adjustment, and as a practical matter, doing so would cause extra work for the manufacturer and the state, as the adjustments may require manual calculations outside of your GP system. Consider too, that the states could opt to take their budget considerations a step further and instruct their providers to stop approving claims and buying your products when the money runs dry.
In the end, it looks like surprises are to be expected now and then. Can manufacturers accrue for them so they hurt less? The budget shortfall scenario can be considered a case study for the wisdom of getting to know the states and how they operate. Those processing Medicaid invoices may be able to help their Accounting counterparts by sharing insights about such state-to-state nuances so that the historical data trend used to establish accruals is expanded to capture more quarters for a more predictable pattern. The J-Code solution seems more elusive. I know of no centralized effort currently underway (or planned) designed to compile a report in which states are able to process all of their required J-Code claims or how much of a backlog exists. Short of doing that, it looks like we can all look forward to more surprises in the future.
If you have questions about processing your state Medicaid claims, please contact me at karenagama@cis-partners.com!
karenagama@cis-partners.com
One quarter, a state bills for a little over $3,500.00. The next, over $40,000.00!! All the summary level variance tests look fine, and wondering how this can possibly be, you ask the state for claims level detail. Not seeing anything amiss with the numbers, you call your state contact for an explanation of the 1,000+% increase. Your end of the conversation sounds something like, “Oh, I see…the state withholds reimbursement to its providers when it runs out of budget money at its fiscal year end, then catches up when the coffers are replenished in the new budget year. The state has withheld reimbursement for six months? Oh, yes. I do see service dates in the detailed data that correspond with that period. Thank you for the explanation.” Now, you have to prepare your message to the higher ups in your company to help them understand how this can happen when dealing with Medicaid programs and why the accrual projections did not set aside nearly enough of your company’s budget money for the payment that’s about to hit the books.
How can this happen? Is this practice allowed? If this scenario can occur, what else could pop up? Can manufacturers ever know if a shock like this is lurking around the proverbial bend?
Since the Medicaid Drug Rebate Program (MDRP) was instituted with the Omnibus Budget Reconciliation Act of 1990 (OBRA ’90), no restriction on the amount of time for which the states could seek retroactive rebates has ever been imposed. A manufacturer could therefore expect to potentially be invoiced for claims, or receive adjustments to prior claims invoiced, going all the way back to 1991. Fortunately, the states are generally more current in their submissions, but it is possible and allowable for states to present manufacturers with the scenario described above, and with smatterings of “found” claims from prior periods in the current period’s invoice totals. It works the other way, too, with states reversing claims from prior periods that have been found to be ineligible for the MDRP.
A second scenario relates to the submission of congested J-Code (HCPCS) claims. Since January 2008, states have been required to submit utilization data for all single-source, and at least the top 20 multiple-source, physician-administered drugs, but identifying which multiple-source product’s NDC is associated with an HCPCS claim has historically been problematic. To facilitate state submission of these claims, an NDC to HCPCS crosswalk table was established (see https://www.dmepdac.com/crosswalk/index.html), and physicians are required to report the NDCs of the products used in each procedure. With these resources in place, the Deficit Reduction Act of 2005 (DRA) prohibits the states from receiving federal participation related to physician-administered drugs unless they submit claims as required.
State governments are not always adequately funded or resourced to move quickly on these types of mandates, and may either outsource the work to a qualified vendor or update their internal systems and processes. In either case, creating multiple-source crosswalks can be slow and laborious, and for process-specific reasons, the result can be multiple quarters submitted within a single invoice processing cycle.
Are manufacturers then allowed to rebate at the rate that was in effect at the time of the original claims service? In the J-Code scenario, each quarter’s claims are typically invoiced separately, even though they are all sent at one time, so the rebate is calculated at the period-specific rate. Where the budget causes the backlog, there is no provision in the law for making any such adjustment, and as a practical matter, doing so would cause extra work for the manufacturer and the state, as the adjustments may require manual calculations outside of your GP system. Consider too, that the states could opt to take their budget considerations a step further and instruct their providers to stop approving claims and buying your products when the money runs dry.
In the end, it looks like surprises are to be expected now and then. Can manufacturers accrue for them so they hurt less? The budget shortfall scenario can be considered a case study for the wisdom of getting to know the states and how they operate. Those processing Medicaid invoices may be able to help their Accounting counterparts by sharing insights about such state-to-state nuances so that the historical data trend used to establish accruals is expanded to capture more quarters for a more predictable pattern. The J-Code solution seems more elusive. I know of no centralized effort currently underway (or planned) designed to compile a report in which states are able to process all of their required J-Code claims or how much of a backlog exists. Short of doing that, it looks like we can all look forward to more surprises in the future.
If you have questions about processing your state Medicaid claims, please contact me at karenagama@cis-partners.com!
Wednesday, October 21, 2009
Busted! : Emerging Drug Anti-Counterfeiting Technologies
By: Jess Ebert, CIS Compliance Associate
jessicaebert@cis-partners.com
Over the years, pharmaceutical companies have sunk millions of dollars into anti-counterfeiting efforts, and yet counterfeit drugs still remain a prevalent (and growing) public health concern. Not only are consumers receiving medication that they believe is safe and effective, but harm can befall the manufacturers as well. Irreparable damage can be done to a company’s reputation due to a loss of brand integrity, leading to a significant loss of profits. An influx of costly returns and recalls can also be expected, further damaging company image and possibly resulting in consumer litigation. The World Health Organization (WHO) estimates that the black market for fraudulent drugs will be worth $75 billion by 2010. It is also estimated that 10% of drugs that enter the global supply chain are counterfeit (this figure rises to more than 25% in developing countries) [1]. Considering the effects that fraudulent medication can have on consumers and manufacturers alike, the question is, what anti-counterfeiting efforts does your company have in place, and how effective are they?
The statistics above are evidence enough to show that counterfeiters are able to get around many of the roadblocks the industry is throwing at them. With every new control, we see an increase in the sophistication and technical capabilities of counterfeiters. To give you a background on the types of problems counterfeits can cause, here are six categories into which fraudulent drugs can be placed:
Serialization
Packaging serialization is gaining a lot of momentum lately due to its effectiveness in preventing counterfeiting, as well as allowing traceability of products from the point of manufacturing to the pharmacy. Serialization refers to a unique code that is printed on the primary package or on the unit-dose tablet or capsule. The codes are “written” onto a radio-frequency identification (RFID) tag for tracking. The codes are then uploaded into a repository database that can be accessed by pharmacists, regulatory agencies, and even the consumer. It also serves as a resource for ensuring that returned product is legitimate, and for conducting recalls more efficiently [2].
It’s always wise to stay ahead of regulatory requirements and many agencies are requiring use of serialized bar codes for products, beginning in Turkey in 2010 and in France in 2011. California has instituted a similar requirement called the ePedigree law, which takes effect in January 2015, and requires that a unique mark be placed on each product’s package [2].
Surface Analysis Techniques
Surface analysis techniques have been become invaluable to the pharmaceutical industry, because not only can they identify counterfeit product, but they can also identify whether the product was manufactured using a licensed or unlicensed process. The following are two of the techniques that have been developed:
Physical Chemical Identifiers (PCIDs)
In July 2009, the Food and Drug Administration (FDA) issued a draft guidance titled “Draft Guidance for Industry: Incorporation of Physical Chemical Identifiers into Solid Oral Dosage Form Products for Anticounterfeiting.” The document provides guidance to manufacturers on the addition of inks, pigments, flavors, and other identifiers to medications in order to make them more difficult to duplicate by counterfeiters.
According to the guidance, a PCID “is a substance or combination of substances possessing a unique physical or chemical property that unequivocally identifies and authenticates a drug product or dosage form.”
In addition to inks, pigments and flavors, which are easily detectable by wholesalers, pharmacists and patients, manufacturers can also add molecular taggants. Taggants can be physical or chemical markers added to materials to allow for specific testing and identification of the marked product. In these cases, specialized instruments and techniques are needed to detect the PCIDs (e.g., photolithography, laser scanning devices) [3].
The FDA anticipates that most of the chemical identifiers will be food additives that are currently in use and have established safety profiles. Safe as they may be, the FDA is still recommending that the lowest detectable level of PCIDs be used to minimize side effects in drug products [3].
Space Age Technology (literally)
In early September, a team of scientists from Perpetuity Research and Consultancy International (PRCI) and the University of Leicester’s Space Research Centre, revealed that they discovered a way to quickly identify counterfeit drugs [5]. The technology, which can detect the differences in the characteristics of light reflecting from printed packaging of drug products, was developed from a spectrograph originally designed for the Space Research Centre.[4].
“The unique light source incorporated within the systems and the selection of the critical points in the packaging at which the tests are conducted provides a degree of randomness that is not known to the counterfeiter and restricts the ability to be replicated.” Trials so far have produced a 100% success rate of detecting differences in printed packaging that the naked eye could not detect [4].
Counterfeiters have proven that they have the knowledge and resources to keep up with the obstacles that the industry throws at them. In order to protect consumers and company reputation, manufacturers must always strive to be one step ahead, and must constantly assess their anti-counterfeiting programs and their effectiveness. The above mentioned techniques are a good place to start!
[1]- http://www.pharmaquality.com/ME2/Audiences/dirmod.asp?sid=325598564E8C4B3EB736C7159241312D&nm=&type=Publishing&mod=Publications%3A%3AArticle&mid=D3E3C719D8D44216836DCA4F4144BEC4&tier=4&id=42EFE4778B8B431A96B18708EA8262ED&AudID=
[2]- http://www.verifybrand.com/brand-protection-news/pdfs/How-serialization-can-reduce-pharma-counterfeiting.pdf
[3]-http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM171575.pdf
[4]- http://www.medicalnewstoday.com/printerfriendlynews.php?newsid=163257
jessicaebert@cis-partners.com
Over the years, pharmaceutical companies have sunk millions of dollars into anti-counterfeiting efforts, and yet counterfeit drugs still remain a prevalent (and growing) public health concern. Not only are consumers receiving medication that they believe is safe and effective, but harm can befall the manufacturers as well. Irreparable damage can be done to a company’s reputation due to a loss of brand integrity, leading to a significant loss of profits. An influx of costly returns and recalls can also be expected, further damaging company image and possibly resulting in consumer litigation. The World Health Organization (WHO) estimates that the black market for fraudulent drugs will be worth $75 billion by 2010. It is also estimated that 10% of drugs that enter the global supply chain are counterfeit (this figure rises to more than 25% in developing countries) [1]. Considering the effects that fraudulent medication can have on consumers and manufacturers alike, the question is, what anti-counterfeiting efforts does your company have in place, and how effective are they?
The statistics above are evidence enough to show that counterfeiters are able to get around many of the roadblocks the industry is throwing at them. With every new control, we see an increase in the sophistication and technical capabilities of counterfeiters. To give you a background on the types of problems counterfeits can cause, here are six categories into which fraudulent drugs can be placed:
- Products without active pharmaceutical ingredients (APIs)
- Products with incorrect quantities of APIs
- Products with the wrong ingredients
- Products with the correct quantities of APIs but with fake packaging
- Products with high levels of impurities and contaminants
- Copies of the original product made using unlicensed manufacturing processes
Serialization
Packaging serialization is gaining a lot of momentum lately due to its effectiveness in preventing counterfeiting, as well as allowing traceability of products from the point of manufacturing to the pharmacy. Serialization refers to a unique code that is printed on the primary package or on the unit-dose tablet or capsule. The codes are “written” onto a radio-frequency identification (RFID) tag for tracking. The codes are then uploaded into a repository database that can be accessed by pharmacists, regulatory agencies, and even the consumer. It also serves as a resource for ensuring that returned product is legitimate, and for conducting recalls more efficiently [2].
It’s always wise to stay ahead of regulatory requirements and many agencies are requiring use of serialized bar codes for products, beginning in Turkey in 2010 and in France in 2011. California has instituted a similar requirement called the ePedigree law, which takes effect in January 2015, and requires that a unique mark be placed on each product’s package [2].
Surface Analysis Techniques
Surface analysis techniques have been become invaluable to the pharmaceutical industry, because not only can they identify counterfeit product, but they can also identify whether the product was manufactured using a licensed or unlicensed process. The following are two of the techniques that have been developed:
- X-ray Photoelectron Spectroscopy (XPS) is a technique that provides detailed information through analysis of surface material. The information includes composition and empirical formula of a drug, and detects contaminants that are present on the surface.
- Secondary Ion Mass Spectroscopy (SIMS) is a depth profiling technique that analyzes the surface, as well as sub-surface, of a material. Information about the chemical composition is revealed by analyzing ions produced from the material [1].
Physical Chemical Identifiers (PCIDs)
In July 2009, the Food and Drug Administration (FDA) issued a draft guidance titled “Draft Guidance for Industry: Incorporation of Physical Chemical Identifiers into Solid Oral Dosage Form Products for Anticounterfeiting.” The document provides guidance to manufacturers on the addition of inks, pigments, flavors, and other identifiers to medications in order to make them more difficult to duplicate by counterfeiters.
According to the guidance, a PCID “is a substance or combination of substances possessing a unique physical or chemical property that unequivocally identifies and authenticates a drug product or dosage form.”
In addition to inks, pigments and flavors, which are easily detectable by wholesalers, pharmacists and patients, manufacturers can also add molecular taggants. Taggants can be physical or chemical markers added to materials to allow for specific testing and identification of the marked product. In these cases, specialized instruments and techniques are needed to detect the PCIDs (e.g., photolithography, laser scanning devices) [3].
The FDA anticipates that most of the chemical identifiers will be food additives that are currently in use and have established safety profiles. Safe as they may be, the FDA is still recommending that the lowest detectable level of PCIDs be used to minimize side effects in drug products [3].
Space Age Technology (literally)
In early September, a team of scientists from Perpetuity Research and Consultancy International (PRCI) and the University of Leicester’s Space Research Centre, revealed that they discovered a way to quickly identify counterfeit drugs [5]. The technology, which can detect the differences in the characteristics of light reflecting from printed packaging of drug products, was developed from a spectrograph originally designed for the Space Research Centre.[4].
“The unique light source incorporated within the systems and the selection of the critical points in the packaging at which the tests are conducted provides a degree of randomness that is not known to the counterfeiter and restricts the ability to be replicated.” Trials so far have produced a 100% success rate of detecting differences in printed packaging that the naked eye could not detect [4].
Counterfeiters have proven that they have the knowledge and resources to keep up with the obstacles that the industry throws at them. In order to protect consumers and company reputation, manufacturers must always strive to be one step ahead, and must constantly assess their anti-counterfeiting programs and their effectiveness. The above mentioned techniques are a good place to start!
[1]- http://www.pharmaquality.com/ME2/Audiences/dirmod.asp?sid=325598564E8C4B3EB736C7159241312D&nm=&type=Publishing&mod=Publications%3A%3AArticle&mid=D3E3C719D8D44216836DCA4F4144BEC4&tier=4&id=42EFE4778B8B431A96B18708EA8262ED&AudID=
[2]- http://www.verifybrand.com/brand-protection-news/pdfs/How-serialization-can-reduce-pharma-counterfeiting.pdf
[3]-http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM171575.pdf
[4]- http://www.medicalnewstoday.com/printerfriendlynews.php?newsid=163257
Friday, October 16, 2009
Articles of the Week!
Courtesy of: Clarissa Crain, CIS Compliance Director
clarissacrain@cis-partners.com
This week in the industry healthcare reform continues to be on the radar screen as legislation continues to be drafted and bipartisan support continues to be sought.
Health bill clears hurdle with support from Snowe
http://news.yahoo.com/s/ap/20091013/ap_on_go_co/us_health_care_overhaul
Senate Panel Passes Bill Limiting Generic Drug Deals
http://online.wsj.com/article/BT-CO-20091015-712619.html
On October 16, 2009 Pfizer announced that it was combining operations with Wyeth. While questions remain with respects to the impact to both companies, initial announcements have been made.
Pfizer And Wyeth Become One: Working Together For A Healthier World™
http://www.pfizer.com/news/press_releases/pfizer_press_releases.jsp?rssUrl=http://mediaroom.pfizer.com/portal/site/pfizer/index.jsp?ndmViewId=news_view&ndmConfigId=1016273&newsId=20091015006478&newsLang=en
Pfizer Closes Wyeth Sites in New Jersey, Pennsylvania
http://www.bloomberg.com/apps/news?pid=20601103&sid=ajmYujiT2rFQ
Articles of the Week! is back by popular demand. Look for it every Friday on the PCB. Have a great weekend, bloggers!
For Your Space,
Dana Zelig and Jess Ebert, PCB Editors
clarissacrain@cis-partners.com
This week in the industry healthcare reform continues to be on the radar screen as legislation continues to be drafted and bipartisan support continues to be sought.
Health bill clears hurdle with support from Snowe
http://news.yahoo.com/s/ap/20091013/ap_on_go_co/us_health_care_overhaul
Senate Panel Passes Bill Limiting Generic Drug Deals
http://online.wsj.com/article/BT-CO-20091015-712619.html
On October 16, 2009 Pfizer announced that it was combining operations with Wyeth. While questions remain with respects to the impact to both companies, initial announcements have been made.
Pfizer And Wyeth Become One: Working Together For A Healthier World™
http://www.pfizer.com/news/press_releases/pfizer_press_releases.jsp?rssUrl=http://mediaroom.pfizer.com/portal/site/pfizer/index.jsp?ndmViewId=news_view&ndmConfigId=1016273&newsId=20091015006478&newsLang=en
Pfizer Closes Wyeth Sites in New Jersey, Pennsylvania
http://www.bloomberg.com/apps/news?pid=20601103&sid=ajmYujiT2rFQ
Articles of the Week! is back by popular demand. Look for it every Friday on the PCB. Have a great weekend, bloggers!
For Your Space,
Dana Zelig and Jess Ebert, PCB Editors
Thursday, October 15, 2009
What Do We Know About Compounding Pharmacies?
By: Amy VanDeCar, CIS Compliance Manager
amyvandecar@cis-partners.com
On a recent trip to New Jersey and Pennsylvania, I was struck by a series of ads on satellite radio for “quick dissolve” versions of some very popular prescription medicines. Having previously worked for branded and generic manufacturers, I have some knowledge of the time, expense and effort involved in securing approval for a new drug. In listening to the ads, however, I realized that I don’t know what the rules are for compounding pharmacies. Do they have an approval process similar to what generic manufacturers go through in submitting an ANDA? Are they exempt from this process because they are simply modifying an approved, branded product? Or, am I correct to question the legitimacy of the products being advertised?
To find out, I began by performing an internet search for “compounding pharmacies.” The first site that came up was the very official-looking “IACP – International Academy of Compounding Pharmacists” site.[i] According to the site, IACP’s mission is ‘to promote and advance personalized medical solutions’ for people whose healthcare needs cannot be met by off-the-shelf medications. The site explains that “trained, licensed pharmacists… work with physicians, nurse practitioners and veterinarians to create customized medication solutions.” That sounds good, but doesn’t tell me much about the rules under which the compounding pharmacies operate.
Continuing my search, I found a site for the Pharmacy Compounding Accreditation Board.[ii] This site provided more information about the legal basis and boundaries for compounding pharmacies. Apparently, compounding activities fall under the regulation and oversight of state boards of pharmacy. Compounding may be conducted for use in physician offices or in anticipation of routine prescription orders. Quantities, in the later case, are limited to “reasonable quantities,” though that is not defined on the PCAB site. Compounding activities may not duplicate commercially available products, but may modify existing products by changing the strength, delivery mechanism or dosage form, or by removing dyes. While this provided some general guidelines, it did not answer the question of the regulatory basis for compounding activities.
Next, I turned to the US Pharmacopeia (USP) site, where I found a white paper[iii] describing “non-governmental and governmental approaches to provide compounding standards and conformity assessment to these standards.” From this, I learned that the question of whether compounded drug products constitute “new drugs,” subject to all of the corresponding regulations, remains unanswered, as does the legality of advertising compounded drugs, though the most recent rulings on the matter leave the door open for advertising these products. The site confirms that the practice of compounding is regulated by state boards of pharmacy. USP notes that while this has translated into considerable variance in regulations, NABP has provided template language for use in developing rules.
Turning finally to the FDA website, I confirmed that the FDA typically defers to states in the regulation of compounding activities. However, the FDA retains the authority to proceed without the states. The FDA has identified factors triggering federal enforcement as “instances where pharmacists are:
Sources:
[i] http://www.iacprx.org/site/PageServer?pagename=home_page
[ii] http://www.pcab.info/
[iii] http://www.usp.org/pdf/EN/members/goodMedicine.pdf
[iv]http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107836.htm, see “Red Flags”
amyvandecar@cis-partners.com
On a recent trip to New Jersey and Pennsylvania, I was struck by a series of ads on satellite radio for “quick dissolve” versions of some very popular prescription medicines. Having previously worked for branded and generic manufacturers, I have some knowledge of the time, expense and effort involved in securing approval for a new drug. In listening to the ads, however, I realized that I don’t know what the rules are for compounding pharmacies. Do they have an approval process similar to what generic manufacturers go through in submitting an ANDA? Are they exempt from this process because they are simply modifying an approved, branded product? Or, am I correct to question the legitimacy of the products being advertised?
To find out, I began by performing an internet search for “compounding pharmacies.” The first site that came up was the very official-looking “IACP – International Academy of Compounding Pharmacists” site.[i] According to the site, IACP’s mission is ‘to promote and advance personalized medical solutions’ for people whose healthcare needs cannot be met by off-the-shelf medications. The site explains that “trained, licensed pharmacists… work with physicians, nurse practitioners and veterinarians to create customized medication solutions.” That sounds good, but doesn’t tell me much about the rules under which the compounding pharmacies operate.
Continuing my search, I found a site for the Pharmacy Compounding Accreditation Board.[ii] This site provided more information about the legal basis and boundaries for compounding pharmacies. Apparently, compounding activities fall under the regulation and oversight of state boards of pharmacy. Compounding may be conducted for use in physician offices or in anticipation of routine prescription orders. Quantities, in the later case, are limited to “reasonable quantities,” though that is not defined on the PCAB site. Compounding activities may not duplicate commercially available products, but may modify existing products by changing the strength, delivery mechanism or dosage form, or by removing dyes. While this provided some general guidelines, it did not answer the question of the regulatory basis for compounding activities.
Next, I turned to the US Pharmacopeia (USP) site, where I found a white paper[iii] describing “non-governmental and governmental approaches to provide compounding standards and conformity assessment to these standards.” From this, I learned that the question of whether compounded drug products constitute “new drugs,” subject to all of the corresponding regulations, remains unanswered, as does the legality of advertising compounded drugs, though the most recent rulings on the matter leave the door open for advertising these products. The site confirms that the practice of compounding is regulated by state boards of pharmacy. USP notes that while this has translated into considerable variance in regulations, NABP has provided template language for use in developing rules.
Turning finally to the FDA website, I confirmed that the FDA typically defers to states in the regulation of compounding activities. However, the FDA retains the authority to proceed without the states. The FDA has identified factors triggering federal enforcement as “instances where pharmacists are:
- Compounding drug products that have been pulled from the market because they were found to be unsafe or ineffective.
- Compounding drugs that are essentially copies of a commercially available drug product.
- Compounding drugs in advance of receiving prescriptions, except in very limited quantities relating to the amounts of drugs previously compounded based on valid prescriptions.
- Compounding finished drugs from bulk active ingredients that aren't components of FDA-approved drugs, without an FDA-sanctioned, investigational new-drug application.
- Receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot of the drug substance has been made in an FDA-registered facility.
- Failing to conform to applicable state law regulating the practice of pharmacy.”[iv]
Sources:
[i] http://www.iacprx.org/site/PageServer?pagename=home_page
[ii] http://www.pcab.info/
[iii] http://www.usp.org/pdf/EN/members/goodMedicine.pdf
[iv]http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107836.htm, see “Red Flags”
Wednesday, October 14, 2009
FDA Raises Debar
By Aimee Hummel, CIS Compliance Manager
aimeehummel@cis-partners.com
On August 8, 2009, the FDA announced that they are revamping their disbarment and disqualification procedures. This decision was made after the FDA’s internal review concluded that it needed to act quicker to ensure the safety of clinical trial participants. Their procedures are also being enhanced to ensure the safety and effectiveness of the medical products marketed to the American public.
Before this, members of Congress had claimed that the FDA has been slow to remove individuals from the drug development process and have not adequately used its debarment and disqualification authorities, which caused major concern. The changes made include increased staffing and centralized organization. They also have designated an administrative law judge as a presiding officer and have assigned the good clinical practice program to oversee the disqualification process. The FDA believes these changes will result in more rapid, transparent and consistent actions. [3]
For those not familiar with this process, the FDA has the authority to disqualify researchers from conducting clinical testing on new drugs and devices when they have repeatedly or deliberately broken the rules. These rules are intended to protect study participants and the general public. Under the FDA’s statutory debarment authority, they may also ban, or “debar” individuals and companies convicted of certain felonies or misdemeanors related to drug products. “Once individuals have been subjected to “debarment,” they may no longer work for anyone with an approved or pending drug product application at FDA. Debarred companies may no longer submit abbreviated drug applications.” [2]
FDA began disqualifying clinical investigators in the early 1960’s and have since disqualified approximately 190 clinical investigations. From 2006 to present, FDA initiated 21 disqualification actions. Since FDA received its debarment authority in 1992, it has debarred 75 individuals convicted of crimes related to drug products. Until this year, the agency had averaged two or three debarment proceedings per year, over the past decade. Since October 2008, however, FDA has formally initiated debarment proceedings against five individuals, and debarred two others.[2]
Since the new changes have been made, the number of debarment actions has risen considerably, and the time taken to resolve both disqualification and debarment actions has reduced significantly. Among the improvements, FDA has also made sure that all participants in testing and development have access to the necessary debarment and disqualification information. Thia information will also ensure that sponsors of clinical studies do not use individuals who may have been disqualified or debarred. Disqualification and Debarment information is available on the FDA website, where you can view all pending and completed disqualification proceedings and all completed debarment proceedings; they are working on doing the same for pending debarment proceedings.
By increasing transparency and enhancing their systems, the FDA will continue to increase the level of protection of the public health. [1]
Information on pending and completed disqualifications can be found at: www.fda.gov/ICECI/EnforcementActions/DisqualifiedRestrictedAssuranceList/ucm131681.htm
Information on completed debarment action can be found at: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090279.htm
Sources:
1 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176040.htm
2 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176043.htm
3 http://www.outsourcing-pharma.com/content/view/print/255930
aimeehummel@cis-partners.com
On August 8, 2009, the FDA announced that they are revamping their disbarment and disqualification procedures. This decision was made after the FDA’s internal review concluded that it needed to act quicker to ensure the safety of clinical trial participants. Their procedures are also being enhanced to ensure the safety and effectiveness of the medical products marketed to the American public.
Before this, members of Congress had claimed that the FDA has been slow to remove individuals from the drug development process and have not adequately used its debarment and disqualification authorities, which caused major concern. The changes made include increased staffing and centralized organization. They also have designated an administrative law judge as a presiding officer and have assigned the good clinical practice program to oversee the disqualification process. The FDA believes these changes will result in more rapid, transparent and consistent actions. [3]
For those not familiar with this process, the FDA has the authority to disqualify researchers from conducting clinical testing on new drugs and devices when they have repeatedly or deliberately broken the rules. These rules are intended to protect study participants and the general public. Under the FDA’s statutory debarment authority, they may also ban, or “debar” individuals and companies convicted of certain felonies or misdemeanors related to drug products. “Once individuals have been subjected to “debarment,” they may no longer work for anyone with an approved or pending drug product application at FDA. Debarred companies may no longer submit abbreviated drug applications.” [2]
FDA began disqualifying clinical investigators in the early 1960’s and have since disqualified approximately 190 clinical investigations. From 2006 to present, FDA initiated 21 disqualification actions. Since FDA received its debarment authority in 1992, it has debarred 75 individuals convicted of crimes related to drug products. Until this year, the agency had averaged two or three debarment proceedings per year, over the past decade. Since October 2008, however, FDA has formally initiated debarment proceedings against five individuals, and debarred two others.[2]
Since the new changes have been made, the number of debarment actions has risen considerably, and the time taken to resolve both disqualification and debarment actions has reduced significantly. Among the improvements, FDA has also made sure that all participants in testing and development have access to the necessary debarment and disqualification information. Thia information will also ensure that sponsors of clinical studies do not use individuals who may have been disqualified or debarred. Disqualification and Debarment information is available on the FDA website, where you can view all pending and completed disqualification proceedings and all completed debarment proceedings; they are working on doing the same for pending debarment proceedings.
By increasing transparency and enhancing their systems, the FDA will continue to increase the level of protection of the public health. [1]
Information on pending and completed disqualifications can be found at: www.fda.gov/ICECI/EnforcementActions/DisqualifiedRestrictedAssuranceList/ucm131681.htm
Information on completed debarment action can be found at: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090279.htm
Sources:
1 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176040.htm
2 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176043.htm
3 http://www.outsourcing-pharma.com/content/view/print/255930
Monday, October 12, 2009
Is Vermont Trying to get Manufacturers to Just Stop Detailing and Sampling Altogether?
By Judy Fox, CIS Senior Compliance Manager
judyfox@cis-partners.com
Notice of Public Hearing on Advisability of Requiring Disclosure of Free Samples
of Prescribed Products given to Vermont Health Care Providers
The goals of the hearing are to gather information about the current system of distribution of free samples of pharmaceuticals, biologics and medical devices to Vermont prescribers, and to hear the opinion of those in the health care system as to the advisability of requiring disclosure.
The Attorney General is encouraging those who testify to address the following questions:
The industry as a whole recognizes the regulations of the Prescription Drug Marketing Act (PDMA), and documents the distribution of drugs to practitioners. The intent of the law is to protect the public from adulterated, contaminated and diverted drugs. The only problem is that all of the storage and documentation requirements end once the drug is left with the practitioner. At the very least, storage requirements should be enforced until the public receives the samples. It is probably a whole other argument, but if the idea is to protect the public from the cost of prescription products, there should be some concern for the safety of the product as well.
The Vermont Attorney General would do well to listen carefully to the industry at these public hearing and carefully explore the pros and cons of any additional regulations. Even though there are only a handful of other states that have similar requirements, the industry is beyond frustrated by regulations passed by those that don’t fully understand our business. Vermont may not have to worry about any manufacturers if they aren’t careful.
With regard to the hearings:
Interested persons are encouraged to participate in the public hearing noticed above. Those wishing to testify in person or by phone must send an email to: prescribedproducts@atg.state.vt.us by October 23, 2009. A preliminary witness list with approximate times of testimony will be posted on the Attorney General’s website, http://www.atg.state.vt.us/ by October 26. Those who do not sign up in advance will be able to testify if time permits. Those who wish to submit proprietary information on a confidential basis may do so by mailing such information, marked “Confidential,” to: Wendy Morgan, Office of the Attorney General, 109 State St., Montpelier VT 05609, no later than November 6, 2009.
The hearing will be taped and posted on the Attorney General’s website. Questions in advance of the hearing should be directed to: prescribedproducts@atg.state.vt.us.
Source:
http://www.atg.state.vt.us/assets/files/Free%20Samples%20Public%20Hearing.pdf
judyfox@cis-partners.com
Notice of Public Hearing on Advisability of Requiring Disclosure of Free Samples
of Prescribed Products given to Vermont Health Care Providers
- Date of hearing: October 27, 2009 ‐‐ 9:30am to 11:30am
- Location: Pavilion Office Building, Third Floor, 109 State St., Montpelier VT
- Sponsored by the Vermont Attorney General and the Commission on Health Care Reform
The goals of the hearing are to gather information about the current system of distribution of free samples of pharmaceuticals, biologics and medical devices to Vermont prescribers, and to hear the opinion of those in the health care system as to the advisability of requiring disclosure.
The Attorney General is encouraging those who testify to address the following questions:
1. How are free samples distributed to Vermont prescribers now? By office visits or mail and upon request only, or through scheduled or unscheduled visits?While the intent and goals of the hearing are understood, and the answers to the questions during the testimony may prove to be helpful, the Attorney General should spend some time investigating at least two additional areas:
2. What records do the manufacturers keep of the distribution of free samples? What records do the recipients keep? If any of those records are reported to a governmental agency, what is reported to which agency on what timeframe?
3. What is the approximate volume and value of free samples being distributed in Vermont?
4. Would disclosure of the distribution of free samples have a significant impact on the willingness of providers to accept those samples? Would it make a difference if
disclosure were only to the Attorney General, and not to the public?
5. What is your opinion on whether the distribution of free samples should be disclosed to the Attorney General’s Office? What is your opinion on whether such disclosures should be released to the public?
1. The number of manufacturers who have chosen to eliminate Vermont prescribers from their detailing targets.Many pharmaceutical manufacturers have chosen to eliminate Vermont territories after weighing the requirements and determining that the effort to comply was not worth the reward. The State may very well be doing its prescribers and citizens a disservice if they make it even more difficult to market prescription products to health care providers. Marketing prescription products has gotten a bad rap over the years and is often perceived as sales representatives running around dumping samples and pushing the provider to prescribe their product. In fact, both medical device and drug representatives can help a practitioner stay informed of new studies, products, and better treatments through detailing and sampling. Manufacturers may just find it harder to justify in Vermont.
2. The method health providers use to track drug samples once they take possession of them.
The industry as a whole recognizes the regulations of the Prescription Drug Marketing Act (PDMA), and documents the distribution of drugs to practitioners. The intent of the law is to protect the public from adulterated, contaminated and diverted drugs. The only problem is that all of the storage and documentation requirements end once the drug is left with the practitioner. At the very least, storage requirements should be enforced until the public receives the samples. It is probably a whole other argument, but if the idea is to protect the public from the cost of prescription products, there should be some concern for the safety of the product as well.
The Vermont Attorney General would do well to listen carefully to the industry at these public hearing and carefully explore the pros and cons of any additional regulations. Even though there are only a handful of other states that have similar requirements, the industry is beyond frustrated by regulations passed by those that don’t fully understand our business. Vermont may not have to worry about any manufacturers if they aren’t careful.
With regard to the hearings:
Interested persons are encouraged to participate in the public hearing noticed above. Those wishing to testify in person or by phone must send an email to: prescribedproducts@atg.state.vt.us by October 23, 2009. A preliminary witness list with approximate times of testimony will be posted on the Attorney General’s website, http://www.atg.state.vt.us/ by October 26. Those who do not sign up in advance will be able to testify if time permits. Those who wish to submit proprietary information on a confidential basis may do so by mailing such information, marked “Confidential,” to: Wendy Morgan, Office of the Attorney General, 109 State St., Montpelier VT 05609, no later than November 6, 2009.
The hearing will be taped and posted on the Attorney General’s website. Questions in advance of the hearing should be directed to: prescribedproducts@atg.state.vt.us.
Source:
http://www.atg.state.vt.us/assets/files/Free%20Samples%20Public%20Hearing.pdf
Thursday, October 8, 2009
Mergers, Acquisitions and Compliance, Oh My!
By: Sabrina Skari, CIS Business Development Manager
sabrinaskari@cis-partners.com
You can look anywhere in the media to find news reports about the numerous buyouts occurring in the pharmaceutical industry. There is the mega-merger between Pfizer, Inc. and Wyeth Pharmaceuticals (Pfizer purchased Wyeth for $68.103 billion, this is the 3rd largest deal in pharmaceutical industry history [1]), the acquisition of Schering-Plough by Merck, Ltd and the fact that Roche purchased Genentech… just to name a few. The leadership teams of these buying entities have a specific goal in mind: to create broad, diversified product portfolios that appeal to as many markets as possible. However, where red tape and bureaucracy are involved, matters are bound to get complicated. So while everyone in pharma questions what these mergers mean for the industry in the long-term, it is also important to ask what these mergers mean for compliance risk!
There is a phrase that defines the need to examine these types of issues: “compliance due diligence.” This refers to the process by which an organization aims to ensure it is aware of any compliance related issues it may inherit in the acquisition of a product or of another company [2]. A company should perform an appropriate level of due diligence, and identified issues that could result in compliance or financial risks can be integrated into the agreement between the companies, including the accountabilities and costs associated with addressing identified issues.
A few key areas to pay attention to include:
In some cases, just showing that you are working on the creation of a unified compliance strategy may minimize the risk of fines. This is helpful because the process may be a time-consuming one. There are various areas that need to be examined when two companies become one. If each entity has a sales force, there is a need for one comprehensive field guide and sales and marketing policy. Any changes to this type of documentation would also require updated training for all sales personnel, which in some cases could mean tens of thousands of people. The customer master codes would need to be reviewed to check for consistent integration and assignment between the two respective organizations. Finally, every single policy and procedure would need to be reviewed and consolidated.
With all of this said, this type of integration among companies is a “worst case scenario” for the amount of work that may need to be done. According to Jim Edwards on the BNET blog, it is possible that these mergers could result in companies that “look a bit like Johnson and Johnson: a collection of relatively small units working autonomously [3].” This doesn’t necessarily mean that there is a right or wrong way to operate. It just implies that an increased level of autonomy among divisions provides a basis for fewer required changes.
Until these mergers are finalized no one can know what the end result will be. Only one thing is for sure- compliance risks affect everyone, big and small. Regardless of how well established a company may or may not be, everyone needs to be cognizant of their respective compliance risks and do everything in their power to mitigate these threats.
SOURCES:
[1] Pharmaceutical Executive, March 2009
[2] http://hcca-info.org/content/navigationmenu/aboutHCCA/PressReleases/duedil.pdf
[3] http://industry.bnet.com/pharma/1000996/post-merger-pfizer-wyeth-might-be-structured-like-jj/?tag=content;col1
sabrinaskari@cis-partners.com
You can look anywhere in the media to find news reports about the numerous buyouts occurring in the pharmaceutical industry. There is the mega-merger between Pfizer, Inc. and Wyeth Pharmaceuticals (Pfizer purchased Wyeth for $68.103 billion, this is the 3rd largest deal in pharmaceutical industry history [1]), the acquisition of Schering-Plough by Merck, Ltd and the fact that Roche purchased Genentech… just to name a few. The leadership teams of these buying entities have a specific goal in mind: to create broad, diversified product portfolios that appeal to as many markets as possible. However, where red tape and bureaucracy are involved, matters are bound to get complicated. So while everyone in pharma questions what these mergers mean for the industry in the long-term, it is also important to ask what these mergers mean for compliance risk!
There is a phrase that defines the need to examine these types of issues: “compliance due diligence.” This refers to the process by which an organization aims to ensure it is aware of any compliance related issues it may inherit in the acquisition of a product or of another company [2]. A company should perform an appropriate level of due diligence, and identified issues that could result in compliance or financial risks can be integrated into the agreement between the companies, including the accountabilities and costs associated with addressing identified issues.
A few key areas to pay attention to include:
- Government program compliance, and integrity of statutory pricing calculations
- Accuracy in Class of Trade Assignment
- BaseAMP impact (where an acquiring company inherits the Base AMP of a product, and any future CPIU Penalties
- Systems used for Medicaid Claims processing, and ability to integrate in historical claims
- Commercial Compliance, such as Grant Activity and Sampling, and assumptions on Bona Fide Fees for Service
In some cases, just showing that you are working on the creation of a unified compliance strategy may minimize the risk of fines. This is helpful because the process may be a time-consuming one. There are various areas that need to be examined when two companies become one. If each entity has a sales force, there is a need for one comprehensive field guide and sales and marketing policy. Any changes to this type of documentation would also require updated training for all sales personnel, which in some cases could mean tens of thousands of people. The customer master codes would need to be reviewed to check for consistent integration and assignment between the two respective organizations. Finally, every single policy and procedure would need to be reviewed and consolidated.
With all of this said, this type of integration among companies is a “worst case scenario” for the amount of work that may need to be done. According to Jim Edwards on the BNET blog, it is possible that these mergers could result in companies that “look a bit like Johnson and Johnson: a collection of relatively small units working autonomously [3].” This doesn’t necessarily mean that there is a right or wrong way to operate. It just implies that an increased level of autonomy among divisions provides a basis for fewer required changes.
Until these mergers are finalized no one can know what the end result will be. Only one thing is for sure- compliance risks affect everyone, big and small. Regardless of how well established a company may or may not be, everyone needs to be cognizant of their respective compliance risks and do everything in their power to mitigate these threats.
SOURCES:
[1] Pharmaceutical Executive, March 2009
[2] http://hcca-info.org/content/navigationmenu/aboutHCCA/PressReleases/duedil.pdf
[3] http://industry.bnet.com/pharma/1000996/post-merger-pfizer-wyeth-might-be-structured-like-jj/?tag=content;col1
Wednesday, October 7, 2009
The Year of the Pig Flu
Jordan Mummau, CIS Compliance Associate
jordanmummau@cis-partners.com
Hello, my name is Jordan and I am a hypochondriac. When the first case of Swine Flu (H1N1) was announced I was sure I had it too. I began involuntarily coughing every time I heard about another incident. As I sit here writing this blog with an 8 oz bottle of waterless hand sanitizer by my side, I remain free from Swine Flu, yet still take every precaution. I was initially unaware of what Swine Flu really was when it first started to spread. Everyone has one of those friends who is commonly known as the “over exaggerator.” You know, the guy that tells the most ridiculous and ludicrous stories, which don’t hold the slightest bit of truth to them, but he explains the stories in such a way as to make them believable (if you do not have a friend like this, chances are, you are this person). Unfortunately, this was the source I received my initial information from regarding the Swine Flu. Long story short, I was under the impression that the virus was spreading through meat, animals, humans, parents, in-laws (which I figured already), etc. I was told that the virus was immediately fatal and I was strongly recommended to stay away from livestock. I was also told that it was in my best interest not to finish the rest of my pulled pork sandwich which I was eating during this conversation (fiction- added for dramatic effect). If you surround yourself with friends like this, you can see how you may become a hypochondriac too (give me a call to hear the anthrax story).
Since the virus is still spreading, it is important for people to know what the H1N1 virus actually is, and what the FDA is doing to help prevent and treat it. “Pandemic Influenza A,” “H1N1 flu,” or “Swine Flu,” is a virus that was originally known only to infect pigs. However, the current outbreak of Swine Flu has mutated in such a way that has allowed the virus to be hosted by humans[i] . The only way to get the virus is from other humans, not from pigs (the animals). The symptoms correlate with the seasonal flu; cough, sore throat, chills, etc. While the H1N1 virus may not be as bad as I originally anticipated, the World Health Organization still considers it a “Global Emergency.”
Similar to the seasonal flu virus, the severity of hospitalizations caused by the H1N1 virus varies greatly from mild cases to fatalities[ii]. The FDA said it initiated the emergency-use authorizations in response to requests from the U.S. Centers for Disease Control and Prevention for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test[iii]. It appears that the virus is being found mostly within teens and young adults; however it is most severe in young children, seniors, and those with prior respiratory complications.
The epidemic may not mean lightning-quick spontaneous internal combustion. It may not spread through your pets, or through your favorite midnight snack (bacon). However, the virus has proven to be problematic and, although I’m trying to keep this blog ‘light’ to keep your attention, it is no laughing matter; the Massachusetts Department of Public Health alone announced over 20,000 reported cases of Swine Flu since the virus first appeared five months ago[iv]. It is unnecessary to be a hypochondriac but it is necessary to take precautionary steps to prevent the disease from spreading. The best way to prevent the disease is to wash your hands and to refrain from touching your face and mouth.
Sources:
[i] "Swine Flu." WebMd.com. Web. 1 Oct. 2009. http://www.webmd.com/cold-and-flu/flu-guide/swine-flu-faq-1?page=7
[ii] "Swine Flu." WebMd.com. Web. 1 Oct. 2009. http://www.webmd.com/cold-and-flu/flu-guide/swine-flu-faq-1?page=7
[iii] "FDA Issues Emergency Swine Flu Orders." UPI.com. Science News, 28 Apr. 2009. Web. 1 Oct. 2009. http://www.upi.com/Science_News/2009/04/28/FDA-issues-emergency-swine-flu-orders/UPI-80371240925627/
[iv] Smith, Stephen. "Swine Flu has infected 20,000 in Mass., More Cases Expected." Boston.com. WhiteCoatNotes, 30 Sept. 2009. Web. 1 Oct. 2009. http://www.boston.com/news/health/blog/2009/09/swine_flu_has_i.html
jordanmummau@cis-partners.com
Hello, my name is Jordan and I am a hypochondriac. When the first case of Swine Flu (H1N1) was announced I was sure I had it too. I began involuntarily coughing every time I heard about another incident. As I sit here writing this blog with an 8 oz bottle of waterless hand sanitizer by my side, I remain free from Swine Flu, yet still take every precaution. I was initially unaware of what Swine Flu really was when it first started to spread. Everyone has one of those friends who is commonly known as the “over exaggerator.” You know, the guy that tells the most ridiculous and ludicrous stories, which don’t hold the slightest bit of truth to them, but he explains the stories in such a way as to make them believable (if you do not have a friend like this, chances are, you are this person). Unfortunately, this was the source I received my initial information from regarding the Swine Flu. Long story short, I was under the impression that the virus was spreading through meat, animals, humans, parents, in-laws (which I figured already), etc. I was told that the virus was immediately fatal and I was strongly recommended to stay away from livestock. I was also told that it was in my best interest not to finish the rest of my pulled pork sandwich which I was eating during this conversation (fiction- added for dramatic effect). If you surround yourself with friends like this, you can see how you may become a hypochondriac too (give me a call to hear the anthrax story).
Since the virus is still spreading, it is important for people to know what the H1N1 virus actually is, and what the FDA is doing to help prevent and treat it. “Pandemic Influenza A,” “H1N1 flu,” or “Swine Flu,” is a virus that was originally known only to infect pigs. However, the current outbreak of Swine Flu has mutated in such a way that has allowed the virus to be hosted by humans[i] . The only way to get the virus is from other humans, not from pigs (the animals). The symptoms correlate with the seasonal flu; cough, sore throat, chills, etc. While the H1N1 virus may not be as bad as I originally anticipated, the World Health Organization still considers it a “Global Emergency.”
Similar to the seasonal flu virus, the severity of hospitalizations caused by the H1N1 virus varies greatly from mild cases to fatalities[ii]. The FDA said it initiated the emergency-use authorizations in response to requests from the U.S. Centers for Disease Control and Prevention for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test[iii]. It appears that the virus is being found mostly within teens and young adults; however it is most severe in young children, seniors, and those with prior respiratory complications.
The epidemic may not mean lightning-quick spontaneous internal combustion. It may not spread through your pets, or through your favorite midnight snack (bacon). However, the virus has proven to be problematic and, although I’m trying to keep this blog ‘light’ to keep your attention, it is no laughing matter; the Massachusetts Department of Public Health alone announced over 20,000 reported cases of Swine Flu since the virus first appeared five months ago[iv]. It is unnecessary to be a hypochondriac but it is necessary to take precautionary steps to prevent the disease from spreading. The best way to prevent the disease is to wash your hands and to refrain from touching your face and mouth.
Sources:
[i] "Swine Flu." WebMd.com. Web. 1 Oct. 2009. http://www.webmd.com/cold-and-flu/flu-guide/swine-flu-faq-1?page=7
[ii] "Swine Flu." WebMd.com. Web. 1 Oct. 2009. http://www.webmd.com/cold-and-flu/flu-guide/swine-flu-faq-1?page=7
[iii] "FDA Issues Emergency Swine Flu Orders." UPI.com. Science News, 28 Apr. 2009. Web. 1 Oct. 2009. http://www.upi.com/Science_News/2009/04/28/FDA-issues-emergency-swine-flu-orders/UPI-80371240925627/
[iv] Smith, Stephen. "Swine Flu has infected 20,000 in Mass., More Cases Expected." Boston.com. WhiteCoatNotes, 30 Sept. 2009. Web. 1 Oct. 2009. http://www.boston.com/news/health/blog/2009/09/swine_flu_has_i.html
Tuesday, October 6, 2009
The Recession and The Biotechnology Industry: Where Do We Go From Here?
By: Jon Dellaquila, CIS Compliance Manager
jondellaquila@cis-partners.com
During the Federal Reserves’ August meeting, the organization indicated that economic activity in the United States is beginning to level out; signifying what they believe may be the beginning of the end of the economic recession in the United States.[1] As the country exits from the greatest financial crisis since the Great Depression, many industries will be faced with significant economic challenges. In particular, the Biotechnology industry finds itself in a unique situation. During the booming markets of the 90’s when Biotechnology was identified as the next great provider of blockbuster therapeutics, financing from capital markets was readily available. During a seven-year stretch from 1991-1998, equity markets invested approximately $34 billion in the Biotechnology industry.[2] The Dow Jones Industrial Average (DJIA) nearly tripled during this time and many were reaping the benefits of their investments. The DJIA peaked on October 9, 2007 at 14,164 only to see it close at 7,062 on February 27, 2009 – just one and half years later.[3] As the dust settles from this dramatic event, the Biotechnology industry is now evaluating creative solutions in order to ensure they can continue to provide innovative therapeutics.
On average, one out of every five-thousand potential drug candidates makes it to the market. Based on a 2005 evaluation, companies spend approximately $1.2-1.3 billion and 10-15 years throughout the development of a single drug.2 Although this industry has the potential to be very profitable, this result does not come without significant financial investments. Since the recession, the number of potential investors has decreased and loans have become harder to obtain. Without this funding, companies with promising therapeutics do not have the means to further develop their drugs. Facing the prospect of dwindling financial resources, smaller companies are being forced to shut their doors or hope that Big Pharma may come to the rescue. As this situation has created some uneasiness amongst the Biotechnology industry, it has also presented some of the most lucrative opportunities for companies sitting on large sums of cash. It is fair to assume that in the coming months as the country begins to pull itself up from the doldrums of the recession, large companies such as Pfizer, Johnson & Johnson and Merck will begin to acquire smaller biotech companies in order to further diversify and support their pipelines.
In the early to mid 90’s it appeared as though the Biotechnology industry had the potential to rival the size of the pharmaceutical industry. After all, some of the most promising advances in therapeutics over the last 20 years have been discovered by Biotechnology companies. The global recession has suddenly turned the once promising rival to Big Pharma into potentially its next great asset. Due to the high costs associated with the production of biologics compared to pharmaceutical compounds, this may turn out to be a blessing in disguise. Most Biotechnology companies struggle to deliver products to market because they are cash strapped. By teaming up with the cash rich pharmaceutical industry, one can only hope that many promising therapeutics in the early stages of development finally get the funding they need to be developed into life changing therapeutics.
Sources:
[1] Andrews EL. Fed Views Recession as Near an End. New York Times. August 12, 2009.
http://www.nytimes.com/2009/08/13/business/economy/13fed.html. Accessed on 11 Sep 2009.
[2] Guertin PA. The Biotechnology Industry: What’s next?. Biotech J. 2009, 4; 1124-1131.
[3] http://www.the-privateer.com/chart/dow-long.html. Accessed on 11 Sep 2009
jondellaquila@cis-partners.com
During the Federal Reserves’ August meeting, the organization indicated that economic activity in the United States is beginning to level out; signifying what they believe may be the beginning of the end of the economic recession in the United States.[1] As the country exits from the greatest financial crisis since the Great Depression, many industries will be faced with significant economic challenges. In particular, the Biotechnology industry finds itself in a unique situation. During the booming markets of the 90’s when Biotechnology was identified as the next great provider of blockbuster therapeutics, financing from capital markets was readily available. During a seven-year stretch from 1991-1998, equity markets invested approximately $34 billion in the Biotechnology industry.[2] The Dow Jones Industrial Average (DJIA) nearly tripled during this time and many were reaping the benefits of their investments. The DJIA peaked on October 9, 2007 at 14,164 only to see it close at 7,062 on February 27, 2009 – just one and half years later.[3] As the dust settles from this dramatic event, the Biotechnology industry is now evaluating creative solutions in order to ensure they can continue to provide innovative therapeutics.
On average, one out of every five-thousand potential drug candidates makes it to the market. Based on a 2005 evaluation, companies spend approximately $1.2-1.3 billion and 10-15 years throughout the development of a single drug.2 Although this industry has the potential to be very profitable, this result does not come without significant financial investments. Since the recession, the number of potential investors has decreased and loans have become harder to obtain. Without this funding, companies with promising therapeutics do not have the means to further develop their drugs. Facing the prospect of dwindling financial resources, smaller companies are being forced to shut their doors or hope that Big Pharma may come to the rescue. As this situation has created some uneasiness amongst the Biotechnology industry, it has also presented some of the most lucrative opportunities for companies sitting on large sums of cash. It is fair to assume that in the coming months as the country begins to pull itself up from the doldrums of the recession, large companies such as Pfizer, Johnson & Johnson and Merck will begin to acquire smaller biotech companies in order to further diversify and support their pipelines.
In the early to mid 90’s it appeared as though the Biotechnology industry had the potential to rival the size of the pharmaceutical industry. After all, some of the most promising advances in therapeutics over the last 20 years have been discovered by Biotechnology companies. The global recession has suddenly turned the once promising rival to Big Pharma into potentially its next great asset. Due to the high costs associated with the production of biologics compared to pharmaceutical compounds, this may turn out to be a blessing in disguise. Most Biotechnology companies struggle to deliver products to market because they are cash strapped. By teaming up with the cash rich pharmaceutical industry, one can only hope that many promising therapeutics in the early stages of development finally get the funding they need to be developed into life changing therapeutics.
Sources:
[1] Andrews EL. Fed Views Recession as Near an End. New York Times. August 12, 2009.
http://www.nytimes.com/2009/08/13/business/economy/13fed.html. Accessed on 11 Sep 2009.
[2] Guertin PA. The Biotechnology Industry: What’s next?. Biotech J. 2009, 4; 1124-1131.
[3] http://www.the-privateer.com/chart/dow-long.html. Accessed on 11 Sep 2009
Monday, October 5, 2009
Pharmaceutical Market Expected to Get a Little Smaller
By: John Jordan, CIS Compliance Associate
johnjordan@cis-partners.com
With the market rebounding in many areas what is in store for the pharmaceutical industry?
Researchers from Business Monitoring International are predicting a contraction within the pharmaceutical market. The drop will supposedly be around -0.35 percent within the time frame of 2008 – 2013 (1). According to the report, “The contraction is small as we believe that the healthcare reform will allow wider access to medical services due to mandatory insurance cover.”(1)A reason behind this drop would be what researchers are calling the “patent cliff”, in the year 2011. A patent cliff is when a pharmaceutical patent is set to expire (1).
This year alone, over 100 products are set to expire; luckily most are not substantial. All of the products dropping from patent protection will open up the brand drugs to the generic drug market (2). Another problem seems to be that manufacturers are launching fewer products, and are therefore not making up for the patents are expiring.
Another reason behind the drop in the pharmaceutical market is due to in large part the additional growth of cheaper generic drugs. This will cause the generic drug market should expect a growth in sales, as well as, the new healthcare reform.
The contraction of the market is expected to yield a value of $302 billion (1).
Sources:
1. http://www.fiercepharma.com/story/what-we-talk-about-when-we-talk-patent-cliff/2009-01-22
2. http://www.marketresearch.com/product/display.asp?productid=2404162
3. http://www.marketresearch.com/product/display.asp?productid=2404162
johnjordan@cis-partners.com
With the market rebounding in many areas what is in store for the pharmaceutical industry?
Researchers from Business Monitoring International are predicting a contraction within the pharmaceutical market. The drop will supposedly be around -0.35 percent within the time frame of 2008 – 2013 (1). According to the report, “The contraction is small as we believe that the healthcare reform will allow wider access to medical services due to mandatory insurance cover.”(1)A reason behind this drop would be what researchers are calling the “patent cliff”, in the year 2011. A patent cliff is when a pharmaceutical patent is set to expire (1).
This year alone, over 100 products are set to expire; luckily most are not substantial. All of the products dropping from patent protection will open up the brand drugs to the generic drug market (2). Another problem seems to be that manufacturers are launching fewer products, and are therefore not making up for the patents are expiring.
Another reason behind the drop in the pharmaceutical market is due to in large part the additional growth of cheaper generic drugs. This will cause the generic drug market should expect a growth in sales, as well as, the new healthcare reform.
The contraction of the market is expected to yield a value of $302 billion (1).
Sources:
1. http://www.fiercepharma.com/story/what-we-talk-about-when-we-talk-patent-cliff/2009-01-22
2. http://www.marketresearch.com/product/display.asp?productid=2404162
3. http://www.marketresearch.com/product/display.asp?productid=2404162
Thursday, October 1, 2009
Chocolate Smokes?!?!?
By: Beth Kline, CIS Project Manager
bethkline@cis-partners.com
As of September 22, 2009, it is now illegal to sell many candy and fruit flavored tobacco products anywhere in the United States.
I have never smoked a cigarette in my life, except when my Dad forced me to smoke an entire one right in front of him at the age of 12. What a smart man! I have never touched another cigarette again nor have I had any desire to. Since I don’t smoke and pay no attention to cigarette commercials or marketing, it was surprising to me to hear that flavored cigarettes exist and are being marketed with a bent toward kids. WHAT?!? Flavors such as vanilla, orange, chocolate and cherry – definite kid favorites – are incorporated into tobacco products, making these products that much more appealing to children.
This is really ingenious of the tobacco industry – if they can hide the DISGUSTING flavor of the tobacco and get kids hooked on its addictive properties – this is potential guaranteed revenue over many lifetimes. In 2004, 17-year-old smokers were more than three times as likely as those over the age of 25 to smoke flavored cigarettes, and they viewed flavored cigarettes as safer. (1)
Smoking is the leading cause of preventable death in the United States. An important way to reduce the death and disease caused by smoking is to prevent children and adolescents from starting to smoke. (2) Fortunately, the FDA now has the new authority to take a stand against these products in the U.S. HOORAY! This is great news and hopefully will save many young people from a lifetime of battling not only a terrible habit, but potential healthcare issues that could lead to a much shorter life.
Sources:
(1) http://www.nytimes.com/2009/09/23/health/policy/23fda.html
(2) http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/FlavoredTobacco/ucm183199.htm
(3) http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/FlavoredTobacco/default.htm
bethkline@cis-partners.com
As of September 22, 2009, it is now illegal to sell many candy and fruit flavored tobacco products anywhere in the United States.
I have never smoked a cigarette in my life, except when my Dad forced me to smoke an entire one right in front of him at the age of 12. What a smart man! I have never touched another cigarette again nor have I had any desire to. Since I don’t smoke and pay no attention to cigarette commercials or marketing, it was surprising to me to hear that flavored cigarettes exist and are being marketed with a bent toward kids. WHAT?!? Flavors such as vanilla, orange, chocolate and cherry – definite kid favorites – are incorporated into tobacco products, making these products that much more appealing to children.
This is really ingenious of the tobacco industry – if they can hide the DISGUSTING flavor of the tobacco and get kids hooked on its addictive properties – this is potential guaranteed revenue over many lifetimes. In 2004, 17-year-old smokers were more than three times as likely as those over the age of 25 to smoke flavored cigarettes, and they viewed flavored cigarettes as safer. (1)
Smoking is the leading cause of preventable death in the United States. An important way to reduce the death and disease caused by smoking is to prevent children and adolescents from starting to smoke. (2) Fortunately, the FDA now has the new authority to take a stand against these products in the U.S. HOORAY! This is great news and hopefully will save many young people from a lifetime of battling not only a terrible habit, but potential healthcare issues that could lead to a much shorter life.
Sources:
(1) http://www.nytimes.com/2009/09/23/health/policy/23fda.html
(2) http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/FlavoredTobacco/ucm183199.htm
(3) http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/FlavoredTobacco/default.htm
Tuesday, September 29, 2009
Crossing Over: A Sales Representative’s Breakthrough into the World of Government Programs
By: Sabrina Skari, CIS Business Development Manager
sabrinaskari@cis-partners.com
As one of the most recent additions to the CIS team, my perspective on the healthcare industry is different from many of my new peers. I spent the last three years as a Sales Representative calling on family practitioners and internists, and attempting to use my artillery of clinical studies and efficacy measures to sway their prescribing habits. During this time my knowledge of Government Programs was based on the paradigm governing prescribers; I understood these programs as a valuable means to disseminate medicine – often the only means for certain patients to acquire treatment for their ailments.
As I have transitioned into my role as a Business Development Manager at CIS, the paradigm has changed. I can see now that although patients are the ones who directly benefit from the healthcare industry’s breakthroughs, it is the federal and state governments who are often the “customer” that manufacturers must aim to please. This breakthrough, which has been a steady progression over the last month, culminated with my attendance at IIR’s Medicaid Drug Rebate Program Conference in Chicago last week. The conference was overwhelming to say the least. Just a quick peek at the schedule for the three day summit was like taking a peek at a map of a foreign country; a country with an unfamiliar landscape and where the inhabitants spoke another language; however, as time passed I made significant progress.
First, and this was key, I realized that I was not the only person there who wasn’t fluent in “GP.” The session speakers, moderators and chairs exhibited an extreme knowledge and passion for their respective topics, but many spent time sitting in on the other discussions. Furthermore, I learned that many of the manufacturer representatives were sent as ambassadors and not necessarily experts; in fact, many people had backgrounds similar to mine. These attendees came from other functional areas, and as the need for compliance expertise evolved with changes in the healthcare system, their careers evolved as well.
I spent three days absorbed in sessions. During “Best Practices and Considerations to Complement your GP Solution” led by CIS’ own Chris Cobourn and Chrissy Spicer, I learned that the phrase “best practices” is actually passé (use “industry standard” instead). I also learned that the key to maintaining a compliant systems environment is to make like a Boy Scout and “always be prepared” for an internal or external audit. During “Evaluating the Current GP Environment,” led by CIS gurus Chris Cobourn and Katie Lapins, it was made apparent that while not all GP complexities are created equal; they do apply to manufacturers of all shapes and sizes.
It was the speech made by Senator Tom Daschle, “Solving the Healthcare Crisis from the Architect of Obama’s Healthcare Reform,” that helped to bridge my past life in sales with my new responsibilities in GP compliance. Senator Daschle provided perspective when he spoke of transformative moments in history, including the Civil Rights Movement of the 1960’s and the events of September 11th. Regardless of their causes, these events shaped our current perspective of our country, and the healthcare evolution will probably do the same.
It doesn’t matter what side of the fence you’re on in the healthcare industry, politically OR functionally. The fact of the matter is that the healthcare industry accounted for 16.5% of the US Gross Domestic Product in 2008, and is trending to reach 20% by 2016. This is a higher percentage of health care spending than in any other industrialized nation and, as a direct result, the US government is heavily involved in our industry [1]. As government programs aim to improve the welfare of citizens, and manufacturers aim to improve the science of welfare, everyone will be intrinsically connected and GP compliance will provide a basis for fair play.
The difference is that I am now aware that regardless of your position in the industry, the end goal is always the same- to improve health care in our country. I will look back on my attendance at my first IIR MDRP conference as a transformative moment in my GP career. As Senator Daschle commented, “everything is impossible until it is done;” so while it might seem farfetched now that this sales person will ever present at a GP conference, I encourage you to look for me in the coming years.
Source:
[1] http://www.plunkettresearch.com/Industries/HealthCare/HealthCareTrends/tabid/294/Default.aspx
sabrinaskari@cis-partners.com
As one of the most recent additions to the CIS team, my perspective on the healthcare industry is different from many of my new peers. I spent the last three years as a Sales Representative calling on family practitioners and internists, and attempting to use my artillery of clinical studies and efficacy measures to sway their prescribing habits. During this time my knowledge of Government Programs was based on the paradigm governing prescribers; I understood these programs as a valuable means to disseminate medicine – often the only means for certain patients to acquire treatment for their ailments.
As I have transitioned into my role as a Business Development Manager at CIS, the paradigm has changed. I can see now that although patients are the ones who directly benefit from the healthcare industry’s breakthroughs, it is the federal and state governments who are often the “customer” that manufacturers must aim to please. This breakthrough, which has been a steady progression over the last month, culminated with my attendance at IIR’s Medicaid Drug Rebate Program Conference in Chicago last week. The conference was overwhelming to say the least. Just a quick peek at the schedule for the three day summit was like taking a peek at a map of a foreign country; a country with an unfamiliar landscape and where the inhabitants spoke another language; however, as time passed I made significant progress.
First, and this was key, I realized that I was not the only person there who wasn’t fluent in “GP.” The session speakers, moderators and chairs exhibited an extreme knowledge and passion for their respective topics, but many spent time sitting in on the other discussions. Furthermore, I learned that many of the manufacturer representatives were sent as ambassadors and not necessarily experts; in fact, many people had backgrounds similar to mine. These attendees came from other functional areas, and as the need for compliance expertise evolved with changes in the healthcare system, their careers evolved as well.
I spent three days absorbed in sessions. During “Best Practices and Considerations to Complement your GP Solution” led by CIS’ own Chris Cobourn and Chrissy Spicer, I learned that the phrase “best practices” is actually passé (use “industry standard” instead). I also learned that the key to maintaining a compliant systems environment is to make like a Boy Scout and “always be prepared” for an internal or external audit. During “Evaluating the Current GP Environment,” led by CIS gurus Chris Cobourn and Katie Lapins, it was made apparent that while not all GP complexities are created equal; they do apply to manufacturers of all shapes and sizes.
It was the speech made by Senator Tom Daschle, “Solving the Healthcare Crisis from the Architect of Obama’s Healthcare Reform,” that helped to bridge my past life in sales with my new responsibilities in GP compliance. Senator Daschle provided perspective when he spoke of transformative moments in history, including the Civil Rights Movement of the 1960’s and the events of September 11th. Regardless of their causes, these events shaped our current perspective of our country, and the healthcare evolution will probably do the same.
It doesn’t matter what side of the fence you’re on in the healthcare industry, politically OR functionally. The fact of the matter is that the healthcare industry accounted for 16.5% of the US Gross Domestic Product in 2008, and is trending to reach 20% by 2016. This is a higher percentage of health care spending than in any other industrialized nation and, as a direct result, the US government is heavily involved in our industry [1]. As government programs aim to improve the welfare of citizens, and manufacturers aim to improve the science of welfare, everyone will be intrinsically connected and GP compliance will provide a basis for fair play.
The difference is that I am now aware that regardless of your position in the industry, the end goal is always the same- to improve health care in our country. I will look back on my attendance at my first IIR MDRP conference as a transformative moment in my GP career. As Senator Daschle commented, “everything is impossible until it is done;” so while it might seem farfetched now that this sales person will ever present at a GP conference, I encourage you to look for me in the coming years.
Source:
[1] http://www.plunkettresearch.com/Industries/HealthCare/HealthCareTrends/tabid/294/Default.aspx
Thursday, September 24, 2009
My IIR MDRP 2009 Recap: “30 is the new 74…”
By: Steven Moore, CIS Director of Business Development
stevenmoore@cis-partners.com
Sunday, 1:46PM: Headed to the airport with my wife driving and realizing that leaving on a Sunday during football time on a 75 degree sunny day is the equivalent of a root canal with no Novocain.
Sunday, 2:09PM: Go through security; get virtually naked, some ladies scream, blah, blah, blah. This travel thing does get old sometimes…
Sunday, 2:13PM: I spot Clarissa Crain and realize that my feelings about leaving on a Sunday are bettered by her feelings. The look on her face made me certain that only allowing butter knives on the other side of security is, in fact, a good thing for more than just the obvious reasons.
Sunday, 3:20PM: “Because I’m leavin’ on a jet plane…”
Sunday, 4:17PM: Arrive in Chicago and text and call my wife, check all the football scores and my fantasy team (which stinks), prove the Pythagorean Theorem and look up some good restaurants in Chicago --- all before we get to the gate. Say what you will, technology is amazing.
Sunday, 4:46PM: Pass Soldier Field and can see that it’s packed for the Bears – Steelers game. I realize that my aforementioned root canal continues as it is one heck of a game shaping up. I’m in Chicago --- so Go Bears! Oh wait, my boss is a Steelers fan.
Go Bears!
Sunday, 5:21PM: Unpack as fast as I’ve ever unpacked and sprint to the bar to watch the end of a great football game (of course after reviewing my emails and studying the new HR 3200 bill). The GP Homecoming begins and I enjoy some football with some good friends. The drill is out of the dentist’s hands…
Sunday, 10:00PM: After dinner diet sodas with some clients...
Sunday, 11:20PM: Some clients/competitors go out and I decide that 30 is the new 74 and call it an early night. I am subsequently mocked --- and then receive multiple text messages that question my manhood. I would much prefer to watch the end of the Giants – Cowboys game with GP Practice Lead Chris Cobourn in our room.
I applaud CIS for room sharing, but I’m not sure about the lone King Bed.
Monday, 1:00PM: (Yes, nothing really happened before that). Booth set up. Insert {expletive} here.
Monday, 6:00PM: Dinner with a big group. I proceed to explain the ‘waves’ to our table and realize that, at age 30 and after last night’s performance, that I might be slowly be becoming a 2nd waiver (this doesn’t last --- trust me).
Monday, 7:54PM: I finish my steak and then help finish one of my favorite client’s and my ‘twin’s’ steak. “CIS: we’ll even eat your leftovers.”
Monday, 9:34PM: Watching my favorite team, the Miami Dolphins, play the Indianapolis Colts on Monday Night Football --- with friends from Indianapolis.
Monday, 11:11PM (make a wish): One of my friends from Indianapolis quietly leaves the table, returns with a Peyton Manning jersey and the Dolphins proceed to blow the game.
Monday 11:12PM: I cry for the first time since watching “Ghost.” (Shout out to Patrick Swayze.) Hootie’s line, “I’m such a baby, yeah, the Dolphin’s make me cry” encapsulates me. Okay, for the record, I just really wanted to show up and use the word ‘encapsulate’ in a sentence. For those of you who don’t know who Hootie is or what I’m talking about, you haven’t lived.
Tuesday, 8:15AM: Tom Daschle, keynote speaker for the conference is on. I have a client call.
Tuesday, 9:30AM: Alice Valder Curran from Hogan & Hartson speaks. I have a client call.
For those of you outside the industry and our space, let me make a comparison of what just happened to me in a couple of ways:
Missing Tom & Alice speak is like missing Phil Mickelson and Tiger Woods tee off in succession.
…or missing Mickey and Minnie at Disney World.
Tuesday, 10:15AM (Networking Break): “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.”
Tuesday, 12:15PM: Lunch and it’s not ‘Conference Chicken’. For those of you unfamiliar with ‘Conference Chicken’, consider yourselves lucky. It’s not chicken, it’s flavored polyethylene.
Tuesday, 5:00PM: The Cocktail Hour begins. It might just be me, but it seems the wine is really flowing for a couple of folks…
Tuesday, 6:30PM: Dinner at Volare --- and it’s dang good! By the end, our table is playing ‘stack the wine corks’ and Chris Cobourn breaks the record with a total of 5 stacked one upon the other. I know what you’re thinking and you’re wrong. Much like the waiting room of a Pediatrician’s office, Chris asked for something to play with as we waited in between appetizers, dinner, desserts, etc. and they supplied us with 6 or so wine corks.
If you believe this, I have some air to sell you…
Tuesday, 8:45PM – 1:30AM: Drinks at the hotel bar followed by the 3rd waivers conspiring to go out. I gladly oblige and head to the rest room as I am told, “We’ll wait for you by the cab.” I return to the lobby and nobody I was leaving with is inside or outside, so I take the cab out to the agreed upon destination. I get to said destination and nobody I know is there. I finally reach CIS’ Chrissy Spicer via phone and nobody ever left the hotel. Sweet.
Tuesday, 12:21AM: During my cab ride, I learn that my driver is from Afghanistan and can’t stop talking about how much he loves America even though he lost 4 family members in a bombing prior to coming here. Let’s take a moment and think about our brave troops and what they’re doing and trying to preserve --- and, no matter how you slice it, how awesome our country and freedom truly are.
(Seriousness ‘off’)
Wednesday, 12:40PM: Clarissa Crain, Chrissy Spicer and I survive the most amazing cab ride to Midway as the cab driver drove over the curb TWICE to get us there and during the second time screamed, “Yeah Baby” while honking his horn. Upon arrival at the terminal he seriously (God as my witness) almost took out a TSA agent…and continued laughing as if we were on Space Mountain in Disney World. I turn to Clarissa and Chrissy and say, “Do you think that my wife will believe the reason I look so tired and worn out was actually the cab ride and not nights out dancing and drinking diet soda?”
Wednesday, 12:41PM: I clean out my shorts.
Wednesday, 1:01PM: I get two gigantic slices of Chicago style pizza to fulfill this aching need to eat grease. I’m only able to finish 1 and a half and realize that it might not have been the smartest move with 2 and half our plane ride ahead.
Wednesday, 2:15PM: Our Southwest Flight Attendant says, during his pre-takeoff gig (paraphrased):
Smoking is not allowed on the plane at any time, but should you choose to do so, I can guarantee the following three things:
1. I will be forced to use the “F” word, as in “Felony”.
2. The FBI will come on the plane and drag you out while we all point and laugh.
3. You will be sent to prison in an orange jumpsuit and put in a cell with a man named Bubba who will definitely think you’re pretty.
Wednesday, 2:17PM: Southwest gets a second nod here as the Flight Attendant says: “Please start by affixing your mask first followed by the child whom you believe has the best chance of putting you in a good retirement home. I know someone who didn’t pick the right child once and they ended up in Jersey.”
Wednesday, 2:17PM: And a 3rd nod as he comes on and says, “We’re currently in a holding pattern for about 20 minutes or so, which shouldn’t be too bad considering once we land in Philadelphia, it should take about 6-8 days to taxi to the gate.” Not sure which reputation is worse: Philadelphia’s Eagle fans or her Airport?
Wednesday, 5:43PM: I see my wife and all in my world is right.
To all my friends new and old, thank you for another great conference!
For Your Space,
Steven
stevenmoore@cis-partners.com
Sunday, 1:46PM: Headed to the airport with my wife driving and realizing that leaving on a Sunday during football time on a 75 degree sunny day is the equivalent of a root canal with no Novocain.
Sunday, 2:09PM: Go through security; get virtually naked, some ladies scream, blah, blah, blah. This travel thing does get old sometimes…
Sunday, 2:13PM: I spot Clarissa Crain and realize that my feelings about leaving on a Sunday are bettered by her feelings. The look on her face made me certain that only allowing butter knives on the other side of security is, in fact, a good thing for more than just the obvious reasons.
Sunday, 3:20PM: “Because I’m leavin’ on a jet plane…”
Sunday, 4:17PM: Arrive in Chicago and text and call my wife, check all the football scores and my fantasy team (which stinks), prove the Pythagorean Theorem and look up some good restaurants in Chicago --- all before we get to the gate. Say what you will, technology is amazing.
Sunday, 4:46PM: Pass Soldier Field and can see that it’s packed for the Bears – Steelers game. I realize that my aforementioned root canal continues as it is one heck of a game shaping up. I’m in Chicago --- so Go Bears! Oh wait, my boss is a Steelers fan.
Go Bears!
Sunday, 5:21PM: Unpack as fast as I’ve ever unpacked and sprint to the bar to watch the end of a great football game (of course after reviewing my emails and studying the new HR 3200 bill). The GP Homecoming begins and I enjoy some football with some good friends. The drill is out of the dentist’s hands…
Sunday, 10:00PM: After dinner diet sodas with some clients...
Sunday, 11:20PM: Some clients/competitors go out and I decide that 30 is the new 74 and call it an early night. I am subsequently mocked --- and then receive multiple text messages that question my manhood. I would much prefer to watch the end of the Giants – Cowboys game with GP Practice Lead Chris Cobourn in our room.
I applaud CIS for room sharing, but I’m not sure about the lone King Bed.
Monday, 1:00PM: (Yes, nothing really happened before that). Booth set up. Insert {expletive} here.
Monday, 6:00PM: Dinner with a big group. I proceed to explain the ‘waves’ to our table and realize that, at age 30 and after last night’s performance, that I might be slowly be becoming a 2nd waiver (this doesn’t last --- trust me).
Monday, 7:54PM: I finish my steak and then help finish one of my favorite client’s and my ‘twin’s’ steak. “CIS: we’ll even eat your leftovers.”
Monday, 9:34PM: Watching my favorite team, the Miami Dolphins, play the Indianapolis Colts on Monday Night Football --- with friends from Indianapolis.
Monday, 11:11PM (make a wish): One of my friends from Indianapolis quietly leaves the table, returns with a Peyton Manning jersey and the Dolphins proceed to blow the game.
Monday 11:12PM: I cry for the first time since watching “Ghost.” (Shout out to Patrick Swayze.) Hootie’s line, “I’m such a baby, yeah, the Dolphin’s make me cry” encapsulates me. Okay, for the record, I just really wanted to show up and use the word ‘encapsulate’ in a sentence. For those of you who don’t know who Hootie is or what I’m talking about, you haven’t lived.
Tuesday, 8:15AM: Tom Daschle, keynote speaker for the conference is on. I have a client call.
Tuesday, 9:30AM: Alice Valder Curran from Hogan & Hartson speaks. I have a client call.
For those of you outside the industry and our space, let me make a comparison of what just happened to me in a couple of ways:
Missing Tom & Alice speak is like missing Phil Mickelson and Tiger Woods tee off in succession.
…or missing Mickey and Minnie at Disney World.
Tuesday, 10:15AM (Networking Break): “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.”
Tuesday, 12:15PM: Lunch and it’s not ‘Conference Chicken’. For those of you unfamiliar with ‘Conference Chicken’, consider yourselves lucky. It’s not chicken, it’s flavored polyethylene.
Tuesday, 5:00PM: The Cocktail Hour begins. It might just be me, but it seems the wine is really flowing for a couple of folks…
Tuesday, 6:30PM: Dinner at Volare --- and it’s dang good! By the end, our table is playing ‘stack the wine corks’ and Chris Cobourn breaks the record with a total of 5 stacked one upon the other. I know what you’re thinking and you’re wrong. Much like the waiting room of a Pediatrician’s office, Chris asked for something to play with as we waited in between appetizers, dinner, desserts, etc. and they supplied us with 6 or so wine corks.
If you believe this, I have some air to sell you…
Tuesday, 8:45PM – 1:30AM: Drinks at the hotel bar followed by the 3rd waivers conspiring to go out. I gladly oblige and head to the rest room as I am told, “We’ll wait for you by the cab.” I return to the lobby and nobody I was leaving with is inside or outside, so I take the cab out to the agreed upon destination. I get to said destination and nobody I know is there. I finally reach CIS’ Chrissy Spicer via phone and nobody ever left the hotel. Sweet.
Tuesday, 12:21AM: During my cab ride, I learn that my driver is from Afghanistan and can’t stop talking about how much he loves America even though he lost 4 family members in a bombing prior to coming here. Let’s take a moment and think about our brave troops and what they’re doing and trying to preserve --- and, no matter how you slice it, how awesome our country and freedom truly are.
(Seriousness ‘off’)
Wednesday, 12:40PM: Clarissa Crain, Chrissy Spicer and I survive the most amazing cab ride to Midway as the cab driver drove over the curb TWICE to get us there and during the second time screamed, “Yeah Baby” while honking his horn. Upon arrival at the terminal he seriously (God as my witness) almost took out a TSA agent…and continued laughing as if we were on Space Mountain in Disney World. I turn to Clarissa and Chrissy and say, “Do you think that my wife will believe the reason I look so tired and worn out was actually the cab ride and not nights out dancing and drinking diet soda?”
Wednesday, 12:41PM: I clean out my shorts.
Wednesday, 1:01PM: I get two gigantic slices of Chicago style pizza to fulfill this aching need to eat grease. I’m only able to finish 1 and a half and realize that it might not have been the smartest move with 2 and half our plane ride ahead.
Wednesday, 2:15PM: Our Southwest Flight Attendant says, during his pre-takeoff gig (paraphrased):
Smoking is not allowed on the plane at any time, but should you choose to do so, I can guarantee the following three things:
1. I will be forced to use the “F” word, as in “Felony”.
2. The FBI will come on the plane and drag you out while we all point and laugh.
3. You will be sent to prison in an orange jumpsuit and put in a cell with a man named Bubba who will definitely think you’re pretty.
Wednesday, 2:17PM: Southwest gets a second nod here as the Flight Attendant says: “Please start by affixing your mask first followed by the child whom you believe has the best chance of putting you in a good retirement home. I know someone who didn’t pick the right child once and they ended up in Jersey.”
Wednesday, 2:17PM: And a 3rd nod as he comes on and says, “We’re currently in a holding pattern for about 20 minutes or so, which shouldn’t be too bad considering once we land in Philadelphia, it should take about 6-8 days to taxi to the gate.” Not sure which reputation is worse: Philadelphia’s Eagle fans or her Airport?
Wednesday, 5:43PM: I see my wife and all in my world is right.
To all my friends new and old, thank you for another great conference!
For Your Space,
Steven
Wednesday, September 23, 2009
Public Hearing on Promotion via the Internet
Christian Didizian, CIS Compliance Manager
chrisdidizian@cis-partners.com
Back on June 4th I posted a blog article entitled New Draft Guidance on Presentation of Risk Information, highlighting the FDA draft guidance Presenting Risk Information in Prescription Drug and Medical Device Promotion. To summarize that entry, I acknowledge that while the guidance was long overdue, it neglected to address issues surrounding promotion through the internet. On September 21st, the FDA announced that these issues would be discussed in a public hearing regarding the promotion of regulated products through the Internet and other methods of DTC advertising/promotion. The hearing will be held on November 12th and 13th from 8 AM to 5 PM. Registration for this hearing is due by October 9, 2009.
This meeting will aid the FDA in forming policy on promoting these products to ensure that all concerns and issues are addressed. The Agency is particularly interested in how “Web 2.0” can be used to promote products in a truthful, non-misleading, and balanced manner to both consumers and health care professionals (Federal Register 74:181). Web 2.0 includes new web development and design that facilitates interactive information sharing. Additionally, the FDA is particularly interested in “emerging technologies such as blogs, microblogs, podcasts, social networks and online communities, video sharing, widgets, and wikis” (Federal Register 74:181). I encourage anyone interested in this hearing to read the full announcement by clicking here.
chrisdidizian@cis-partners.com
Back on June 4th I posted a blog article entitled New Draft Guidance on Presentation of Risk Information, highlighting the FDA draft guidance Presenting Risk Information in Prescription Drug and Medical Device Promotion. To summarize that entry, I acknowledge that while the guidance was long overdue, it neglected to address issues surrounding promotion through the internet. On September 21st, the FDA announced that these issues would be discussed in a public hearing regarding the promotion of regulated products through the Internet and other methods of DTC advertising/promotion. The hearing will be held on November 12th and 13th from 8 AM to 5 PM. Registration for this hearing is due by October 9, 2009.
This meeting will aid the FDA in forming policy on promoting these products to ensure that all concerns and issues are addressed. The Agency is particularly interested in how “Web 2.0” can be used to promote products in a truthful, non-misleading, and balanced manner to both consumers and health care professionals (Federal Register 74:181). Web 2.0 includes new web development and design that facilitates interactive information sharing. Additionally, the FDA is particularly interested in “emerging technologies such as blogs, microblogs, podcasts, social networks and online communities, video sharing, widgets, and wikis” (Federal Register 74:181). I encourage anyone interested in this hearing to read the full announcement by clicking here.
Tuesday, September 22, 2009
The Risks of Showering
By: Suma Kallurkar, CIS Senior Compliance Manager
sumakallurkar@cis-partners.com
Heavy concerns about swine flu this season have led to increased germophobia world-wide. I have never been a germophobe myself, but I undoubtedly have greater concerns now that I am a new mom with an infant in daycare. As if the current fears around the spread of swine flu were not enough, we heard news earlier this week that our showerheads and shower-sprayed water contain significant amounts of bacteria. This news, of course, is disconcerting for anyone. After all, we take showers daily for the purpose of cleansing ourselves, and it is so ironic that quite the opposite could be occurring.
It is really difficult for many to not stress out about the fact that millions of bacteria are hitting your body and face as you shower, and being inhaled into your lungs. But how much of a threat are these shower germs? Scientists at the University of Colorado who conducted this specific study of showerhead microbes found that a variety of complex microbes exist in showerheads that are potentially pathogenic (i.e. can lead to disease). However, the scientists concluded that the actual health risks posed by these organisms requires further investigation, especially in individuals whose immune function is compromised.
So it appears that there is no need to stress too much about the bacteria in our showers. For those who are more concerned, you may be able to minimize the bacteria that come in contact with you by running the shower for 30 seconds prior to getting in, as the amount of bacteria appears to be highest when the shower is first turned on. Additionally, metal showerheads appear to house fewer bacteria than plastic showerheads.
We also need to remind ourselves that millions of microorganisms exist on practically all surfaces and environments that we come in contact with on a daily basis. Obviously, a majority of these germs are harmless, otherwise we would constantly be sick. Swine flu is a legitimate major concern that we do need to pay attention to and take action to prevent the spread of the virus. However, when it comes to showerhead germs, people should relax and continue enjoying their daily showers!
Sources:
http://www.pnas.org/content/early/2009/09/11/0908446106.abstract
http://blogs.forbes.com/sciencebizblog/2009/09/dont-be-afraid-of-the-germs-in-your-shower/
http://www.nytimes.com/2009/09/15/health/15shower.html?_r=2
sumakallurkar@cis-partners.com
Heavy concerns about swine flu this season have led to increased germophobia world-wide. I have never been a germophobe myself, but I undoubtedly have greater concerns now that I am a new mom with an infant in daycare. As if the current fears around the spread of swine flu were not enough, we heard news earlier this week that our showerheads and shower-sprayed water contain significant amounts of bacteria. This news, of course, is disconcerting for anyone. After all, we take showers daily for the purpose of cleansing ourselves, and it is so ironic that quite the opposite could be occurring.
It is really difficult for many to not stress out about the fact that millions of bacteria are hitting your body and face as you shower, and being inhaled into your lungs. But how much of a threat are these shower germs? Scientists at the University of Colorado who conducted this specific study of showerhead microbes found that a variety of complex microbes exist in showerheads that are potentially pathogenic (i.e. can lead to disease). However, the scientists concluded that the actual health risks posed by these organisms requires further investigation, especially in individuals whose immune function is compromised.
So it appears that there is no need to stress too much about the bacteria in our showers. For those who are more concerned, you may be able to minimize the bacteria that come in contact with you by running the shower for 30 seconds prior to getting in, as the amount of bacteria appears to be highest when the shower is first turned on. Additionally, metal showerheads appear to house fewer bacteria than plastic showerheads.
We also need to remind ourselves that millions of microorganisms exist on practically all surfaces and environments that we come in contact with on a daily basis. Obviously, a majority of these germs are harmless, otherwise we would constantly be sick. Swine flu is a legitimate major concern that we do need to pay attention to and take action to prevent the spread of the virus. However, when it comes to showerhead germs, people should relax and continue enjoying their daily showers!
Sources:
http://www.pnas.org/content/early/2009/09/11/0908446106.abstract
http://blogs.forbes.com/sciencebizblog/2009/09/dont-be-afraid-of-the-germs-in-your-shower/
http://www.nytimes.com/2009/09/15/health/15shower.html?_r=2
Thursday, September 17, 2009
IIR's Medicaid Drug Rebate Program Conference
Dear Colleagues and Friends,
CIS will be exhibiting and presenting at IIR’s Medicaid Drug Rebate Program Conference next week, from September 21st – 23rd in Chicago, IL.
CIS’ subject matter experts will be presenting on the following topics:
Best Practices and Considerations to Complement Your GP Solution
Chris Cobourn, VP, Regulatory Compliance
Chrissy Spicer, CIS Senior Compliance Manager
Topics Include:
• Discussing the fundamental elements of establishing a compliant foundation
• Identifying key stakeholders, roles and responsibilities
• Understanding the operational challenges related to source systems and data
• Best practices for aligning your supporting documentation to your GP Solution
• Developing a holistic approach to support the integrity and accuracy of your GP calculations
• Prevailing practices for a sustainable GP Solution
Evaluating the Current GP Environment
Chris Cobourn, VP, Regulatory Compliance
Katie Lapins, CIS Director, Small and Mid-Market Manufacturers
Panelists:
Catrina Hirschauer, Xanodyne Pharmaceuticals
Todd LeDuc, Solvay Pharmaceuticals
Randy Colvin, Allos Therapeutics
All manufacturers, large and small, face similar requirements and challenges in performing their GP Calculations:
• Staying current on regulations, statutes, and guidance
• Ensuring your systems and tools to reflect current methodology
• Ensuring the accuracy of statutory pricing calculations, and having confidence in your certifications
• Making sure that systems and procedures are auditable and meet the requirements of the 10-Year rule
Manufacturers have various options in today’s environment, including performing calculations internally using spreadsheets and databases, outsourcing them to a third party, or implementing a commercial GP system. In this session, we discuss basic requirements of GP systems and tools, and considerations for companies that may be evaluating their options, or want to know how to evaluate the accuracy and overall compliance of their current toolsets. The presentation will include industry case-studies on various approaches to system evaluation.
Track A: Medicaid Payment Process Improvement – Avoid Pitfalls and Duplicate Discounts
Bill Baxter, CIS Strategic Advisor, Government Affairs (Moderator)
Learn to identify and handle these major pitfalls:
• Medicaid as secondary insurance
• Unit of Measure
• Generic substitution
• Incorrect NDC reporting
• Units vs. reimbursed $
• Double dipping
• Adjustments to prior quarter(s)
Hear the fundamentals of Medicaid payment processing and learn to overcome common challenges facing manufacturers today.
Track A: Vigilant Auditing and Monitoring Practices and Procedures
Clarissa Crain (Moderator), CIS Compliance Director
Panelists:
Lisa Kiniklis, Biogen IDEC
Brian McCartney, Ortho-McNeil Janssen
Lorraine Moccio, Johnson & Johnson Health Care Systems
Improve your current procedures to ensure complete auditing & monitoring of your operational areas. Overcome the difficulty of bringing your company’s Internal Audit group up to speed on current MDRP issues. Take part in this session to discuss current DRA auditing practices, and the internal controls necessary to create sufficient analytical and compliance tools.
Track D: A Strategic and Operational View of the Government as a Customer
Chris Cobourn, VP, Regulatory Compliance
In this session we evaluate the current regulatory environment, as well as new and potential changes to Federal and State programs in 2009 and 2010. We discuss how companies can develop a broader view of managing the government as a customer, evaluating potential shifts in publically funded programs, and key components for a manufacturer to consider, such as managing the government customer from a business perspective, operational considerations, and compliance.
Please click here for more conference information!
CIS will be exhibiting and presenting at IIR’s Medicaid Drug Rebate Program Conference next week, from September 21st – 23rd in Chicago, IL.
CIS’ subject matter experts will be presenting on the following topics:
Best Practices and Considerations to Complement Your GP Solution
Chris Cobourn, VP, Regulatory Compliance
Chrissy Spicer, CIS Senior Compliance Manager
Topics Include:
• Discussing the fundamental elements of establishing a compliant foundation
• Identifying key stakeholders, roles and responsibilities
• Understanding the operational challenges related to source systems and data
• Best practices for aligning your supporting documentation to your GP Solution
• Developing a holistic approach to support the integrity and accuracy of your GP calculations
• Prevailing practices for a sustainable GP Solution
Evaluating the Current GP Environment
Chris Cobourn, VP, Regulatory Compliance
Katie Lapins, CIS Director, Small and Mid-Market Manufacturers
Panelists:
Catrina Hirschauer, Xanodyne Pharmaceuticals
Todd LeDuc, Solvay Pharmaceuticals
Randy Colvin, Allos Therapeutics
All manufacturers, large and small, face similar requirements and challenges in performing their GP Calculations:
• Staying current on regulations, statutes, and guidance
• Ensuring your systems and tools to reflect current methodology
• Ensuring the accuracy of statutory pricing calculations, and having confidence in your certifications
• Making sure that systems and procedures are auditable and meet the requirements of the 10-Year rule
Manufacturers have various options in today’s environment, including performing calculations internally using spreadsheets and databases, outsourcing them to a third party, or implementing a commercial GP system. In this session, we discuss basic requirements of GP systems and tools, and considerations for companies that may be evaluating their options, or want to know how to evaluate the accuracy and overall compliance of their current toolsets. The presentation will include industry case-studies on various approaches to system evaluation.
Track A: Medicaid Payment Process Improvement – Avoid Pitfalls and Duplicate Discounts
Bill Baxter, CIS Strategic Advisor, Government Affairs (Moderator)
Learn to identify and handle these major pitfalls:
• Medicaid as secondary insurance
• Unit of Measure
• Generic substitution
• Incorrect NDC reporting
• Units vs. reimbursed $
• Double dipping
• Adjustments to prior quarter(s)
Hear the fundamentals of Medicaid payment processing and learn to overcome common challenges facing manufacturers today.
Track A: Vigilant Auditing and Monitoring Practices and Procedures
Clarissa Crain (Moderator), CIS Compliance Director
Panelists:
Lisa Kiniklis, Biogen IDEC
Brian McCartney, Ortho-McNeil Janssen
Lorraine Moccio, Johnson & Johnson Health Care Systems
Improve your current procedures to ensure complete auditing & monitoring of your operational areas. Overcome the difficulty of bringing your company’s Internal Audit group up to speed on current MDRP issues. Take part in this session to discuss current DRA auditing practices, and the internal controls necessary to create sufficient analytical and compliance tools.
Track D: A Strategic and Operational View of the Government as a Customer
Chris Cobourn, VP, Regulatory Compliance
In this session we evaluate the current regulatory environment, as well as new and potential changes to Federal and State programs in 2009 and 2010. We discuss how companies can develop a broader view of managing the government as a customer, evaluating potential shifts in publically funded programs, and key components for a manufacturer to consider, such as managing the government customer from a business perspective, operational considerations, and compliance.
Please click here for more conference information!
Initial Thought on Committee “Chairman’s Mark”
By: Clarissa Crain, CIS Compliance Director
clarissacrain@cis-partners.com
On Wednesday, September 16th Senator Baucus, Chairman of the Senate Finance Committee, issued his Chairman’s Mark on America’s Health Future Act of 2009. The document outlines the Chairman’s proposals for reform. The plan is estimated to extend coverage to approximately 29 million uninsured Americans over a 10 year period, and cost approximately $856 billion. While the price tag is high, a factor in the lack of Republican support for the outlined reform, it is estimated to trim deficits by $49 million.[i]
The Chairman’s Mark is yet another piece in the ever evolving debate of healthcare reform. While Chairman Baucus and the Senate Finance Committee sought to present a unified, bipartisan position, support for the proposals is lacking. On Wednesday Baucus stood alone presenting the proposals, while Republican members of the Senate Finance Committee opposed the ‘costly and intrusive’ nature of reform, Democrats argued the proposals did not go far enough in ensuring access to affordable healthcare.
For those specifically interested in the impact of the proposals on Government pharmaceutical access programs, “Section V: Medicaid Prescription Drug Coverage,” presents proposals for reform to the Medicaid Drug Rebate Program (MDRP). Section V outlines the following proposals:
Sources:
Werner, Erica. Deep divisions over long-awaited health care plan. http://news.yahoo.com/s/ap/20090917/ap_on_go_co/us_health_care_overhaul. Accessed September 17, 2009.
H.R. 3200: America's Affordable Health Choices Act of 2009. http://www.govtrack.us/congress/billtext.xpd?bill=h111-3200
Chairman’s Mark. America’s Healthy Future Act of 2009. http://finance.senate.gov/sitepages/leg/LEG%202009/091609%20Americas_Healthy_Future_Act.pdf
Committee of Finance News Release. Baucus Introduces Landmark Plan to Lower Health Care Costs, Provide Quality, Affordable Coverage. September 16, 2009. http://finance.senate.gov/press/Bpress/2009press/prb091609a.pdf
clarissacrain@cis-partners.com
On Wednesday, September 16th Senator Baucus, Chairman of the Senate Finance Committee, issued his Chairman’s Mark on America’s Health Future Act of 2009. The document outlines the Chairman’s proposals for reform. The plan is estimated to extend coverage to approximately 29 million uninsured Americans over a 10 year period, and cost approximately $856 billion. While the price tag is high, a factor in the lack of Republican support for the outlined reform, it is estimated to trim deficits by $49 million.[i]
The Chairman’s Mark is yet another piece in the ever evolving debate of healthcare reform. While Chairman Baucus and the Senate Finance Committee sought to present a unified, bipartisan position, support for the proposals is lacking. On Wednesday Baucus stood alone presenting the proposals, while Republican members of the Senate Finance Committee opposed the ‘costly and intrusive’ nature of reform, Democrats argued the proposals did not go far enough in ensuring access to affordable healthcare.
For those specifically interested in the impact of the proposals on Government pharmaceutical access programs, “Section V: Medicaid Prescription Drug Coverage,” presents proposals for reform to the Medicaid Drug Rebate Program (MDRP). Section V outlines the following proposals:
- Prescription drug coverage would become a mandatory benefit within State Medicaid Programs. Today, states may elect whether or not to include this benefit. While all states in the Program currently do offer the benefit, the proposal would make such coverage a mandatory requirement for both categorically and medically needy persons covered by Medicaid.
- The proposals would remove smoking cessation drugs, barbiturates, and benzodiazepines from the list of covered drugs. This would go into effect as of January 1, 2014.
- Similar to the H.R.3200[ii], the current bill in the House, the Chairman’s proposals outline increases in manufacturer rebate liabilities. Single source (S) and innovator multisource (I) drugs would see an increase of the AMP basic rebate percentage from 15.1% to 23.1% for all drugs except those exclusively approved for pediatric use. Those with pediatric exclusivity would have a basic rebate percentage of 17.1%. While rebates would be increased, the total rebate liability for an S or I drug would be limited to 100% of AMP. (note: Best Price (BP) provisions are proposed to remain unchanged.)
- The rebate on non-innovator or generic drugs (N) would be increased from 11% of AMP to 13% of AMP.
- The rebate program would be expanded to make rebates payments for Medicaid managed care organizations (MCOs) utilization a requirement for manufacturers. The rebate payments would be made directly to states.
- Line-extensions or other formulation changes of existing products would no longer be treated as new drugs for purposes of the MDRP. New versions of existing drugs would no longer be able to be associated with new baseline AMPs. Under the proposal, the original formulation’s baseline AMP would follow through to line-extensions. The only exemption to this would be line-extensions of orphan drugs.
- Under the proposal of the Chairman, the Federal Upper Payment Limits (FULs) would be revised from the 250 percent as proposed by the DRA, to 175 percent (see Adam Fein’s Drug Channels Blog on this topic at www.drugchannels.net). Of interest to manufacturers, the utilization of FUL for pharmacy reimbursement is also associated with clarification on the inclusion of transactions, discounts, and other price adjustments in AMP and the disclosure of AMPs. Should this proposal be accepted, look for more changes in AMP calculations.
- The plan refers to the 50% discount manufacturers have agreed to provide to the Medicare Part D program. The discount would be passed on the enrollees purchasing drugs in the “donut hole.”
- Branded pharmaceutical manufacturers with sales of $5 million or more would incur a flat fee of $2.3 billion across the sector beginning in 2010. This non-deductible fee would be distributed across the industry according to market share.
- Medical device manufacturers with sales of $5 million or more would incur a flat fee of $4 billion across the sector beginning in 2010. This non-deductible fee would be distributed across the industry according to market share. The only exemption to this payment would be sales of Class I products.
- Drug manufacturers and distributors would be required to report information related to the number and type of drug samples provided to physicians, through “physician payment sunshine” type legislation.
Sources:
Werner, Erica. Deep divisions over long-awaited health care plan. http://news.yahoo.com/s/ap/20090917/ap_on_go_co/us_health_care_overhaul. Accessed September 17, 2009.
H.R. 3200: America's Affordable Health Choices Act of 2009. http://www.govtrack.us/congress/billtext.xpd?bill=h111-3200
Chairman’s Mark. America’s Healthy Future Act of 2009. http://finance.senate.gov/sitepages/leg/LEG%202009/091609%20Americas_Healthy_Future_Act.pdf
Committee of Finance News Release. Baucus Introduces Landmark Plan to Lower Health Care Costs, Provide Quality, Affordable Coverage. September 16, 2009. http://finance.senate.gov/press/Bpress/2009press/prb091609a.pdf
Tuesday, September 15, 2009
AMP and BP Methodology Changes are a GO!!
By: Debbe Saez, CIS Senior Compliance Manager
debbesaez@cis-partners.com
Do you remember when there was no limit on how many quarters a manufacturer could recalculate AMP or BP? That was more than 6 years ago. On August 29, 2003, CMS issued a final rule, CMS-2175-FC[1], which implemented the limitation on AMP and BP recalculations to a period not to exceed 12 quarters from the quarter in which the data is due. As clear as that rule is, there were still open questions about AMP and BP recalculations. Does the manufacturer always need CMS’ approval to recalculate? What methodology changes, if any, don’t require prior approval? What about pending requests for approval of methodology changes?
To clarify some of these questions, CMS issued guidance in Drug Manufacturer Release #78[2] on July 26, 2007. More recently, on August 26, 2009, CMS posted changes to this guidance in the form of a Spotlight on the Policy & Reimbursement section of CMS’ website[3]. The topics below highlight the key points from Release 78 and the Guidance in the Spotlight.
Topic:
Treatment of pending recalculation requests due to methodology change…
Release 78(July 26, 2007):
Implement methodology changes prospectively.
Spotlight(August 26, 2009):
Requests submitted to CMS before the 12-quarter limitation took effect:
Retroactive requests for methodology changes may be implemented, without prior review and approval from CMS, for the period specified in the request.
Requests submitted to CMS after the 12-quarter limitation took effect:
Manufacturers may implement changes and recalculate for a period not to exceed 12-quarters.(Contact Tamara Bruce at MDROperations@cms.hhs.gov for instructions about the data submission process.)
Topic:
New recalculation requests, after the date of the respective guidance, due to methodology changes…
Release 78(July 26, 2007):
Implement the change on a prospective basis without review by CMS.
Wait for approval from CMS before making retroactive changes.
Spotlight(August 26, 2009):
Both prospective and retroactive changes can made without prior approval by CMS.
Manufacturers are requested to notify CMS of the methodology change.
Retroactive changes are still subject to the 12-quarter limitation.
Topic:
Additional notes…
Release 78(July 26, 2007):
None
Spotlight(August 26, 2009):
CMS suggests that manufacturers work with States to prevent undue burden of rebate overpayment recovery.
CMS also suggests limiting the recovery of overpayments to 25% of the rebate payable in quarter.
Until now, manufacturers could not make retroactive methodology changes to their AMP and BP calculations without approval. The downside to this was that with the passing of each quarter, another quarter would fall out of the period available to implement the changes. Now that this is no longer an issue… let the recalculations begin!!
Sources:
[1] http://edocket.access.gpo.gov/2003/pdf/03-21548.pdf
[2] http://www.cms.hhs.gov/MedicaidDrugRebateProgram/03_DrugMfrReleases.asp
[3] http://www.cms.hhs.gov/Reimbursement/02_Spotlight.asp
debbesaez@cis-partners.com
Do you remember when there was no limit on how many quarters a manufacturer could recalculate AMP or BP? That was more than 6 years ago. On August 29, 2003, CMS issued a final rule, CMS-2175-FC[1], which implemented the limitation on AMP and BP recalculations to a period not to exceed 12 quarters from the quarter in which the data is due. As clear as that rule is, there were still open questions about AMP and BP recalculations. Does the manufacturer always need CMS’ approval to recalculate? What methodology changes, if any, don’t require prior approval? What about pending requests for approval of methodology changes?
To clarify some of these questions, CMS issued guidance in Drug Manufacturer Release #78[2] on July 26, 2007. More recently, on August 26, 2009, CMS posted changes to this guidance in the form of a Spotlight on the Policy & Reimbursement section of CMS’ website[3]. The topics below highlight the key points from Release 78 and the Guidance in the Spotlight.
Topic:
Treatment of pending recalculation requests due to methodology change…
Release 78(July 26, 2007):
Implement methodology changes prospectively.
Spotlight(August 26, 2009):
Requests submitted to CMS before the 12-quarter limitation took effect:
Retroactive requests for methodology changes may be implemented, without prior review and approval from CMS, for the period specified in the request.
Requests submitted to CMS after the 12-quarter limitation took effect:
Manufacturers may implement changes and recalculate for a period not to exceed 12-quarters.(Contact Tamara Bruce at MDROperations@cms.hhs.gov for instructions about the data submission process.)
Topic:
New recalculation requests, after the date of the respective guidance, due to methodology changes…
Release 78(July 26, 2007):
Implement the change on a prospective basis without review by CMS.
Wait for approval from CMS before making retroactive changes.
Spotlight(August 26, 2009):
Both prospective and retroactive changes can made without prior approval by CMS.
Manufacturers are requested to notify CMS of the methodology change.
Retroactive changes are still subject to the 12-quarter limitation.
Topic:
Additional notes…
Release 78(July 26, 2007):
None
Spotlight(August 26, 2009):
CMS suggests that manufacturers work with States to prevent undue burden of rebate overpayment recovery.
CMS also suggests limiting the recovery of overpayments to 25% of the rebate payable in quarter.
Until now, manufacturers could not make retroactive methodology changes to their AMP and BP calculations without approval. The downside to this was that with the passing of each quarter, another quarter would fall out of the period available to implement the changes. Now that this is no longer an issue… let the recalculations begin!!
Sources:
[1] http://edocket.access.gpo.gov/2003/pdf/03-21548.pdf
[2] http://www.cms.hhs.gov/MedicaidDrugRebateProgram/03_DrugMfrReleases.asp
[3] http://www.cms.hhs.gov/Reimbursement/02_Spotlight.asp
Monday, September 14, 2009
Tricky Base AMP Calculations
By: Chris Cobourn, VP of Regulatory Compliance
chriscobourn@cis-partners.com
In working with many of our clients, we have encountered the tricky question of Lagged Rebate Price Concessions and how they figure into the calculation of Base AMP.
Technically speaking, Base AMP is set in the first full quarter of sales. So, if a product was initially sold in November, which occurs in the middle of the 4th Quarter, Base AMP would be set in 1st Quarter, the first full quarter of sales. The problem is that manufacturers sometimes establish initial stocking allowances and other incentives to create market share for new products. These types of discounts have historically been offered prior to the first full quarter of sales.
Prior to the requirement that lagged rebate price concessions be included in AMP, these initial stocking allowances would not be included in the Base AMP calculation, and Base AMP would be set solely on the first full quarter of sales. However, due to the requirement to include lagged or smoothed price concessions, these incentives can now be part of the Base AMP calculation if they can in any way be considered a lagged discount. This can have an unfortunate impact on the manufacturer. The idea of using only the first full quarter of sales to calculate Base AMP seems fair, as doing so creates a Base AMP more aligned with the “normal” quarterly AMP the manufacturer would witness going forward. Including incentives and initial stocking allowances in the calculation can set an artificially low Base AMP, which could set the manufacturer up for increased CPI-U penalties over the course of the product’s life.
This change is important food for thought, as manufacturers consider strategy decisions such as providing initial stocking allowances. Make sure that you are aware of which discounts are lagged, and which are not. In addition, it may be worth modeling various pricing strategies to evaluate the potential impact these decisions will have on the Base AMP, especially relative to the potential sales that may be achieved as a result of those incentives.
chriscobourn@cis-partners.com
In working with many of our clients, we have encountered the tricky question of Lagged Rebate Price Concessions and how they figure into the calculation of Base AMP.
Technically speaking, Base AMP is set in the first full quarter of sales. So, if a product was initially sold in November, which occurs in the middle of the 4th Quarter, Base AMP would be set in 1st Quarter, the first full quarter of sales. The problem is that manufacturers sometimes establish initial stocking allowances and other incentives to create market share for new products. These types of discounts have historically been offered prior to the first full quarter of sales.
Prior to the requirement that lagged rebate price concessions be included in AMP, these initial stocking allowances would not be included in the Base AMP calculation, and Base AMP would be set solely on the first full quarter of sales. However, due to the requirement to include lagged or smoothed price concessions, these incentives can now be part of the Base AMP calculation if they can in any way be considered a lagged discount. This can have an unfortunate impact on the manufacturer. The idea of using only the first full quarter of sales to calculate Base AMP seems fair, as doing so creates a Base AMP more aligned with the “normal” quarterly AMP the manufacturer would witness going forward. Including incentives and initial stocking allowances in the calculation can set an artificially low Base AMP, which could set the manufacturer up for increased CPI-U penalties over the course of the product’s life.
This change is important food for thought, as manufacturers consider strategy decisions such as providing initial stocking allowances. Make sure that you are aware of which discounts are lagged, and which are not. In addition, it may be worth modeling various pricing strategies to evaluate the potential impact these decisions will have on the Base AMP, especially relative to the potential sales that may be achieved as a result of those incentives.
Wednesday, September 9, 2009
Risk & Reward; FDA Expands Access to Investigational Drugs
By: Jordan Mummau, CIS Compliance Associate
jordanmummau@cis-partners.com
On August 12, 2009 the FDA issued two rules that are meant to bring clarity to the ways in which seriously ill patients can gain access to investigational drugs and biologics in cases where there may not be any other satisfactory treatments available. [1]
Unfortunately, some patients are faced with a serious illness that does not react positively to current treatment. Under these circumstances, a drug that shows promise and is under development can be very appealing to patients who have little other choice. The FDA had become aware of this in 1987 when it developed rules that would “allow patients to have access to investigational drugs under certain circumstances, even though the safety and effectiveness of the drug has not been fully established.” [2]
As previously stated, on August 12th the FDA instituted changes to the rules that were originally developed in 1987 so that the rules would apply to a broader population of people who have not had success with approved treatments, and who could have been previously denied access to investigational drugs and biologics. Furthermore, the FDA hopes these new rules will bring more clarity to physicians who are administering investigational drugs and the manufacturers who are developing them. This particular change was described in the Federal Register as a “change to the charging rule to explain when a drug manufacturer can charge a patient for an investigational drug, in a clinical trial or expanded access program, and what costs a manufacturer can recover when charging.” [3]
This could be a tremendous benefit to a sick patient who has run out of all other options. However, the FDA has referred to expanded access to investigational drugs as a “balancing act.” While the FDA understands a promising drug under development could potentially help someone in need, they also notice the risk associated with administering a drug that has not been fully tested. With that said, these new rulings ultimately give patients a choice that may not have been available to them before. The bottom line, per the FDA, is that the potential benefit must outweigh the potential risk. [4]
New Rules at a Glance
•Expanded Access Rule – to permit treatment of a patient with an investigational drug under an expanded access program
oPotential benefit justifies potential risk
•Charging Rule – permits drug manufacturers to charge patients for an investigational drug in clinical trials or that’s being made available for expanded access. Charging in clinical trials will be allowed under very limited circumstances, but will be permitted for most expanded access uses.
oMake process of obtaining authorization to charge more transparent
oSpecify what costs can be recovered by drug manufacturers [5]
Sources:
1) "FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176526.htm
2) "FDA Expands Access to Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm176845.htm
3) "FDA Expands Access to Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm176845.htm
4) "Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm172492.htm
5) "FDA Expands Access to Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm176845.htm
jordanmummau@cis-partners.com
On August 12, 2009 the FDA issued two rules that are meant to bring clarity to the ways in which seriously ill patients can gain access to investigational drugs and biologics in cases where there may not be any other satisfactory treatments available. [1]
Unfortunately, some patients are faced with a serious illness that does not react positively to current treatment. Under these circumstances, a drug that shows promise and is under development can be very appealing to patients who have little other choice. The FDA had become aware of this in 1987 when it developed rules that would “allow patients to have access to investigational drugs under certain circumstances, even though the safety and effectiveness of the drug has not been fully established.” [2]
As previously stated, on August 12th the FDA instituted changes to the rules that were originally developed in 1987 so that the rules would apply to a broader population of people who have not had success with approved treatments, and who could have been previously denied access to investigational drugs and biologics. Furthermore, the FDA hopes these new rules will bring more clarity to physicians who are administering investigational drugs and the manufacturers who are developing them. This particular change was described in the Federal Register as a “change to the charging rule to explain when a drug manufacturer can charge a patient for an investigational drug, in a clinical trial or expanded access program, and what costs a manufacturer can recover when charging.” [3]
This could be a tremendous benefit to a sick patient who has run out of all other options. However, the FDA has referred to expanded access to investigational drugs as a “balancing act.” While the FDA understands a promising drug under development could potentially help someone in need, they also notice the risk associated with administering a drug that has not been fully tested. With that said, these new rulings ultimately give patients a choice that may not have been available to them before. The bottom line, per the FDA, is that the potential benefit must outweigh the potential risk. [4]
New Rules at a Glance
•Expanded Access Rule – to permit treatment of a patient with an investigational drug under an expanded access program
oPotential benefit justifies potential risk
•Charging Rule – permits drug manufacturers to charge patients for an investigational drug in clinical trials or that’s being made available for expanded access. Charging in clinical trials will be allowed under very limited circumstances, but will be permitted for most expanded access uses.
oMake process of obtaining authorization to charge more transparent
oSpecify what costs can be recovered by drug manufacturers [5]
Sources:
1) "FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176526.htm
2) "FDA Expands Access to Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm176845.htm
3) "FDA Expands Access to Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm176845.htm
4) "Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm172492.htm
5) "FDA Expands Access to Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm176845.htm
Tuesday, September 8, 2009
DTC Advertising
By: Grete Dudek, CIS Compliance Associate
gretedudek@cis-partners.com
Although the current healthcare reform discussion has been in the spotlight recently, there is also a less visible battle taking place for restrictions on direct to consumer drug (DTC) advertising. Currently, there are a number of different proposed ideas and methods to restrict DTC ads, but since a number of similar bills have stalled in the past, there is uncertainty regarding whether or not any legislation will be passed. One idea (as discussed in Judy Fox’s article, The Definition of Indecent Could Become Ridiculous), from Representative James P. Moran, a Democrat from Virginia, is to ban prescription drug ads for erectile dysfunction during prime time hours on decency grounds.[1] Representative Henry Waxman, a Democrat from California, would like to see a ban on prescription drug advertising for the first few years the drug is on the market. He said,
The drug Vioxx is one example of a drug with risks that weren’t immediately clear. In long-term studies undertaken after the drug’s approval, an increased risk of cardiovascular events was seen after taking the drug for 18 months. The pain drug was removed from the market over these safety concerns, but had extensive usage and patient exposure due to DTC advertising campaigns.[5] Meanwhile, Representative Jerrold Nadler, a Democrat from New York, has introduced a bill to the House that would deny tax deductions for direct to consumer advertising.[4]
Critics of these restrictions have the right to free speech on their side, which is one reason similar bills have stalled in the past. Studies have found that DTC advertising can make consumers aware that their conditions have effective treatment, and that ads “can help people who do need treatment to start taking, and stay on, appropriate drugs.”[3] The ads can lead to increased patient visits to doctors that detect treatable diseases, and increase the quality of discussions between patients and doctors.[6]
It is also interesting to note that the US and New Zealand are the only two developed countries that allow direct to consumer drug advertisements. However, that almost changed a few years ago, when lawmakers in New Zealand tried and failed to ban DTC advertising. What does the future hold for DTC advertising in the U.S? We will have to wait and see.
Sources:
1. http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.2175:
2. http://www.prescriptionproject.org/tools/conference_remarks/files/0003.pdf
3. http://www.nytimes.com/2009/07/27/business/media/27drugads.html
4. http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.2966:
5. http://www.merck.com/newsroom/vioxx/pdf/vioxx_press_release_final.pdf
6. http://roomfordebate.blogs.nytimes.com/2009/08/04/should-prescription-drug-ads-be-reined-in/
gretedudek@cis-partners.com
Although the current healthcare reform discussion has been in the spotlight recently, there is also a less visible battle taking place for restrictions on direct to consumer drug (DTC) advertising. Currently, there are a number of different proposed ideas and methods to restrict DTC ads, but since a number of similar bills have stalled in the past, there is uncertainty regarding whether or not any legislation will be passed. One idea (as discussed in Judy Fox’s article, The Definition of Indecent Could Become Ridiculous), from Representative James P. Moran, a Democrat from Virginia, is to ban prescription drug ads for erectile dysfunction during prime time hours on decency grounds.[1] Representative Henry Waxman, a Democrat from California, would like to see a ban on prescription drug advertising for the first few years the drug is on the market. He said,
“It is in these first few years of a drug’s life that drug companies often aggressively market their products and engage in direct-to-consumer advertising. This increases the number of consumers exposed to safety risks of new products, long before those risks are truly understood.... That is why I have supported legislation that would grant FDA the authority to restrict direct-to-consumer advertising for an initial period for new drugs on a case-by-case basis.”[2]
The drug Vioxx is one example of a drug with risks that weren’t immediately clear. In long-term studies undertaken after the drug’s approval, an increased risk of cardiovascular events was seen after taking the drug for 18 months. The pain drug was removed from the market over these safety concerns, but had extensive usage and patient exposure due to DTC advertising campaigns.[5] Meanwhile, Representative Jerrold Nadler, a Democrat from New York, has introduced a bill to the House that would deny tax deductions for direct to consumer advertising.[4]
Critics of these restrictions have the right to free speech on their side, which is one reason similar bills have stalled in the past. Studies have found that DTC advertising can make consumers aware that their conditions have effective treatment, and that ads “can help people who do need treatment to start taking, and stay on, appropriate drugs.”[3] The ads can lead to increased patient visits to doctors that detect treatable diseases, and increase the quality of discussions between patients and doctors.[6]
It is also interesting to note that the US and New Zealand are the only two developed countries that allow direct to consumer drug advertisements. However, that almost changed a few years ago, when lawmakers in New Zealand tried and failed to ban DTC advertising. What does the future hold for DTC advertising in the U.S? We will have to wait and see.
Sources:
1. http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.2175:
2. http://www.prescriptionproject.org/tools/conference_remarks/files/0003.pdf
3. http://www.nytimes.com/2009/07/27/business/media/27drugads.html
4. http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.2966:
5. http://www.merck.com/newsroom/vioxx/pdf/vioxx_press_release_final.pdf
6. http://roomfordebate.blogs.nytimes.com/2009/08/04/should-prescription-drug-ads-be-reined-in/
Thursday, September 3, 2009
Healthcare for All Americans, Part Two - Con
By: Scott Hoffman, CIS Senior Associate
scotthoffman@cis-partners.com
Disclaimer: This is Part Two of a two part article on Healthcare Reform. This article represents a position against healthcare reform, yesterday’s article presented a position for universal healthcare. We would love to hear your (constructive) feedback, so feel free to post a comment responding to either position, or both.
I would also like to start this article with a disclaimer for the readers. Healthcare reform is a very complex issue that impacts a wide spectrum of individuals, ranging from manufacturers to insurers to the general public. The information I am going to present in this article is only a high level summary of a few arguments opposing healthcare reform. The reasons I am opposed to government-backed healthcare reform are the failure of the Massachusetts reform, the shortcomings of Medicaid and Medicare and, lastly, the prospective cost to taxpayers.
The first issue I would like to highlight is the failure of the healthcare reform enacted in Massachusetts in 2006. To provide a brief background, on April 12, 2006, Massachusetts passed bipartisan legislature requiring all adults to purchase health insurance. If the individuals did not purchase a plan, fines of up to 50 percent of the cost of a health insurance plan would be levied [1]. Additionally, employers employing 11 or more individuals were required to provide health insurance coverage for their employees, or pay a contribution of up to $295 annually per employee [1]. The other key component of the plan was the provision of government-funded subsidies to low-income individuals to assist with the purchase of health insurance [1].
Three years after the passing of the plan, the healthcare situation in Massachusetts has not improved. First, universal healthcare is still not universal (although roughly half of those previously uninsured have subsequently become insured), and more importantly, surveys show that individuals have “substantial problems in access to care” in the state [2]. The state plan has failed to ensure the availability of comprehensive plans at affordable prices and has actually negatively impacted some individuals by requiring high co-pays that the low income individuals subscribing to the plan cannot afford. [2].
The second issue is that the legislation does nothing to control administrative costs and wasteful spending (it has actually increased healthcare costs), and does nothing to address the key drivers of high health care costs, the overuse of high-technology care and the underdevelopment of primary care [2]. In addition (and in support of my third argument), the plan has cost more than originally estimated, resulting in charges to taxpayers of $1.1 billion and $1.3 billion in 2008 and 2009 respectively, resulting in cuts to other state sponsored programs [2]. To summarize, healthcare costs continue to increase, co-payments are still high and Massachusetts’ budget is a mess, which, to me, represents a clear failure.
After reading the above argument some will say that the government now has a blueprint of what areas it should focus on to make healthcare reform successful; as well as a guide of what not to do. My next point is meant to illustrate that whenever the government gets involved, all you get is a very expensive, poorly forecasted, inefficient program full of “bureaucratic politics.” To illustrate, you only have to look at the government’s last foray into healthcare for the public; Medicare and Medicaid. Since most people reading this are familiar with these two programs, I am going to take a stance on why they are not effective. My main point in bringing up Medicare and Medicaid is not that the programs aren’t beneficial, because I believe they do help their intended targets. However, I feel that the government has not properly forecasted the cost and growth of the programs and, on top of that, they have mismanaged them, resulting in huge deficits.
To illustrate the above point, Medicaid currently represents 7% of the federal budget, and is projected to account for roughly 8.5% by 2013. Total Medicaid expenditures on benefits were $329.4 billion in 2007, and according to the Office of the Actuary, they are predicted to increase at an average of 8% to 9% per year for the next 10 years, reaching $735.2 billion by 2017 [3]. The effects of these cost increases on states already experiencing budget deficits could be significant. Plus, the federal government won’t be able to bail them out because according to the Congressional Budget Office (CBO), the government is currently projected to have a deficit of $7.1 trillion by 2019 [4]. Take a second to consider that amount of money, and then assess whether the government understands how to effectively manage and budget money. Personally, I think the answer is pretty clear.
I will keep my final argument brief because this is only a personal argument opposing government healthcare reform. The government has a deficit of approximately $7.1 trillion dollars and is planning on spending roughly $1 trillion on healthcare reform. Where is the money going to come from? The costs are almost assuredly going to be passed to you and I: the taxpayers. I know there was an agreement with the Pharma industry for $80 billion, but when was the last time any industry just gave away $80 billion (and sponsored a $150 million advertising campaign)? In my research and experience, this has never happened. That means Pharma is planning on not only recouping the $80 billion, but also turning some semblance of a profit (after all, profit is the fundamental principle of business), which means eventually the tax payer is going to be on the hook. I don’t know how you personally feel, but I would like to keep the money I work hard to make, and not give it away to the government.
In closing, I understand the “humane and sympathetic” argument for offering healthcare to all Americans. I also understand that not all Americans are in the same position I am, of having a good job, which allows me to afford healthcare. However, healthcare is not going to help people if the government goes “bankrupt” due to complete financial insolvency. It is not going to help the working class individual who begins to lose large percentages of their earned wages. Why not work to fix Medicare and Medicaid? Why not work on initiatives to increase the number of doctors in this country, to help eliminate access issues?
More importantly, why does reform have to be a government run insurance plan? My main opposition for government-backed and sponsored healthcare is that it will not bring about the changes needed to provide access for those who need it. Any government plan will almost assuredly be mismanaged and full of waste, which will not successfully provide affordable access to healthcare for everyone who needs it. I believe that if the government wants reform, it should avoid offering healthcare plans, and should instead work with private insurers to ensure that affordable plans are offered. From my perspective, government oversight is a significantly better option, both short-term and long-term, than government ownership.
Sources:
[1] Massachusetts Health Care Reform Plan: An Update
http://www.kff.org/uninsured/upload/7494-02.pdf
[2] Massachusetts’ Plan: A Failed Model for Health Care Reform
http://pnhp.org/mass_report/mass_report_Final.pdf
[3] This Is Going to Hurt, August 12, 2009
http://pharmexec.findpharma.com/pharmexec/Web+Exclusives/This-Is-Going-to-Hurt/ArticleStandard/Article/detail/618558?contextCategoryId=47505
[4] Projected Deficits and Surpluses in CBO’s Baseline
http://www.cbo.gov/ftpdocs/105xx/doc10521/budgetprojections.pdf
scotthoffman@cis-partners.com
Disclaimer: This is Part Two of a two part article on Healthcare Reform. This article represents a position against healthcare reform, yesterday’s article presented a position for universal healthcare. We would love to hear your (constructive) feedback, so feel free to post a comment responding to either position, or both.
I would also like to start this article with a disclaimer for the readers. Healthcare reform is a very complex issue that impacts a wide spectrum of individuals, ranging from manufacturers to insurers to the general public. The information I am going to present in this article is only a high level summary of a few arguments opposing healthcare reform. The reasons I am opposed to government-backed healthcare reform are the failure of the Massachusetts reform, the shortcomings of Medicaid and Medicare and, lastly, the prospective cost to taxpayers.
The first issue I would like to highlight is the failure of the healthcare reform enacted in Massachusetts in 2006. To provide a brief background, on April 12, 2006, Massachusetts passed bipartisan legislature requiring all adults to purchase health insurance. If the individuals did not purchase a plan, fines of up to 50 percent of the cost of a health insurance plan would be levied [1]. Additionally, employers employing 11 or more individuals were required to provide health insurance coverage for their employees, or pay a contribution of up to $295 annually per employee [1]. The other key component of the plan was the provision of government-funded subsidies to low-income individuals to assist with the purchase of health insurance [1].
Three years after the passing of the plan, the healthcare situation in Massachusetts has not improved. First, universal healthcare is still not universal (although roughly half of those previously uninsured have subsequently become insured), and more importantly, surveys show that individuals have “substantial problems in access to care” in the state [2]. The state plan has failed to ensure the availability of comprehensive plans at affordable prices and has actually negatively impacted some individuals by requiring high co-pays that the low income individuals subscribing to the plan cannot afford. [2].
The second issue is that the legislation does nothing to control administrative costs and wasteful spending (it has actually increased healthcare costs), and does nothing to address the key drivers of high health care costs, the overuse of high-technology care and the underdevelopment of primary care [2]. In addition (and in support of my third argument), the plan has cost more than originally estimated, resulting in charges to taxpayers of $1.1 billion and $1.3 billion in 2008 and 2009 respectively, resulting in cuts to other state sponsored programs [2]. To summarize, healthcare costs continue to increase, co-payments are still high and Massachusetts’ budget is a mess, which, to me, represents a clear failure.
After reading the above argument some will say that the government now has a blueprint of what areas it should focus on to make healthcare reform successful; as well as a guide of what not to do. My next point is meant to illustrate that whenever the government gets involved, all you get is a very expensive, poorly forecasted, inefficient program full of “bureaucratic politics.” To illustrate, you only have to look at the government’s last foray into healthcare for the public; Medicare and Medicaid. Since most people reading this are familiar with these two programs, I am going to take a stance on why they are not effective. My main point in bringing up Medicare and Medicaid is not that the programs aren’t beneficial, because I believe they do help their intended targets. However, I feel that the government has not properly forecasted the cost and growth of the programs and, on top of that, they have mismanaged them, resulting in huge deficits.
To illustrate the above point, Medicaid currently represents 7% of the federal budget, and is projected to account for roughly 8.5% by 2013. Total Medicaid expenditures on benefits were $329.4 billion in 2007, and according to the Office of the Actuary, they are predicted to increase at an average of 8% to 9% per year for the next 10 years, reaching $735.2 billion by 2017 [3]. The effects of these cost increases on states already experiencing budget deficits could be significant. Plus, the federal government won’t be able to bail them out because according to the Congressional Budget Office (CBO), the government is currently projected to have a deficit of $7.1 trillion by 2019 [4]. Take a second to consider that amount of money, and then assess whether the government understands how to effectively manage and budget money. Personally, I think the answer is pretty clear.
I will keep my final argument brief because this is only a personal argument opposing government healthcare reform. The government has a deficit of approximately $7.1 trillion dollars and is planning on spending roughly $1 trillion on healthcare reform. Where is the money going to come from? The costs are almost assuredly going to be passed to you and I: the taxpayers. I know there was an agreement with the Pharma industry for $80 billion, but when was the last time any industry just gave away $80 billion (and sponsored a $150 million advertising campaign)? In my research and experience, this has never happened. That means Pharma is planning on not only recouping the $80 billion, but also turning some semblance of a profit (after all, profit is the fundamental principle of business), which means eventually the tax payer is going to be on the hook. I don’t know how you personally feel, but I would like to keep the money I work hard to make, and not give it away to the government.
In closing, I understand the “humane and sympathetic” argument for offering healthcare to all Americans. I also understand that not all Americans are in the same position I am, of having a good job, which allows me to afford healthcare. However, healthcare is not going to help people if the government goes “bankrupt” due to complete financial insolvency. It is not going to help the working class individual who begins to lose large percentages of their earned wages. Why not work to fix Medicare and Medicaid? Why not work on initiatives to increase the number of doctors in this country, to help eliminate access issues?
More importantly, why does reform have to be a government run insurance plan? My main opposition for government-backed and sponsored healthcare is that it will not bring about the changes needed to provide access for those who need it. Any government plan will almost assuredly be mismanaged and full of waste, which will not successfully provide affordable access to healthcare for everyone who needs it. I believe that if the government wants reform, it should avoid offering healthcare plans, and should instead work with private insurers to ensure that affordable plans are offered. From my perspective, government oversight is a significantly better option, both short-term and long-term, than government ownership.
Sources:
[1] Massachusetts Health Care Reform Plan: An Update
http://www.kff.org/uninsured/upload/7494-02.pdf
[2] Massachusetts’ Plan: A Failed Model for Health Care Reform
http://pnhp.org/mass_report/mass_report_Final.pdf
[3] This Is Going to Hurt, August 12, 2009
http://pharmexec.findpharma.com/pharmexec/Web+Exclusives/This-Is-Going-to-Hurt/ArticleStandard/Article/detail/618558?contextCategoryId=47505
[4] Projected Deficits and Surpluses in CBO’s Baseline
http://www.cbo.gov/ftpdocs/105xx/doc10521/budgetprojections.pdf
Wednesday, September 2, 2009
Healthcare for All Americans, Part One - Pro
By: Katie Lapins, CIS Director of Small and Mid-Market Pharma
katielapins@cis-partners.com
Disclaimer: This is Part One of a two part article on Healthcare Reform. This article represents a position for universal healthcare, tomorrow’s article presents a position against healthcare reform. We would love to hear your (constructive) feedback, so feel free to post a comment responding to either position, or both.
I would like to begin this article with my own disclaimer for the readers. There are many aspects of the current healthcare debate that I do not fully understand. I am the first to admit that I have not read the entire 1,000+ pages in the proposed bill. I also know that you can find at least one statistic to support your position on almost anything, so while I see merit in both sides of the argument, I cannot state unequivocally which is the most accurate, true or realistic.
However, to me, the debate of healthcare reform is about something entirely different. Healthcare should not be something that only working Americans enjoy. It should not be something that drives a family into bankruptcy or prevents someone from working because they will lose their Medicaid coverage. It should also not be something that bureaucrats or employees, in Washington, DC or in private insurance companies, make decisions about. It should be about having access to the best realistic treatment available for a reasonable fee.
Here are a few examples of what I’m talking about:
In the Denver Post recently, a physician in private practice was interviewed about healthcare reform (1). His daughter was diagnosed with brain cancer and when he and his wife realized they would quickly hit their maximum lifetime benefits, his wife quickly got a job with the City and County of Denver, which has an insurance benefit that does not have a lifetime maximum limit. He decided to close his practice and go to work for Kaiser Permanente, because he claimed that it offered a more sustainable model of healthcare.
An acquaintance of mine quit her job to stay home with a newly adopted child. Shortly thereafter, her husband experienced a significant mental illness which, for safety and legal reasons, meant she had to file for divorce. She was then diagnosed with a brain tumor and because of her financial situation, she qualified for Medicaid. Now that she is healthy, she would like to get a job. Unfortunately, she will not qualify for healthcare because of her pre-existing condition and lack of private insurance. She is therefore better off staying unemployed because she will then continue to qualify for Medicaid. She is willing to pay a premium to stay on Medicaid, and wants to work, but the system does not allow for this option.
An estimated 8,000 people were recently treated in Los Angeles by Regional Area Medical, a non-profit organization first designed to attend to the medical needs of developing countries. They now have waiting lines in the US wherever they go, and are often forced to turn people away (2).
At a similar event in Tennessee, an executive for Cigna realized that the care people were receiving was “in public in stalls intended for livestock.” (3) This executive, Wendell Potter, resigned from his position because he felt like he could no longer participate in a system with a goal of maximizing profits that was not benefitting its constituents.
The insurance industry is in business to maximize its return to shareholders. The more premiums an insurance company can take in and the less it has to pay out for services, the better its returns. This goal is opposite of the goal of the medical industry, which is to prevent, diagnose and treat medical problems. I understand and agree that there are perverse incentives within the medical field to run up huge bills to receive additional fees; therefore, part of any reform should be altering this system. However, I do not believe that outcomes related to these systemic issues negatively impact my treatment in the same way as would an insurance company denying treatment or approving procedures based on cost.
Many critics often claim that the US Government should not be in charge of health insurance. In case people had not noticed, it already is. The US Government administers Medicaid in conjunction with the States, and Medicare is a Federal program that, by all accounts, is extremely successful. The Public Health Service program and the healthcare provided through the Department of Veterans Affairs are also Federal programs that overall, are successful. Are they perfect? Heavens, no, but at least their goal is not the opposite of mine when it comes to my healthcare.
I would like to know what percentage of those who oppose healthcare reform do not have health insurance. How many of them turn down Medicare when they become eligible to participate? It is easy to oppose healthcare reform when you are not the one being denied access or treatment, and when you are not the one filing for bankruptcy because of the cost of treatment.
Basic healthcare is a human right. In the United States, we have the best healthcare in the world, but not the best access in the world. I have heard statistics and personal stories about people having to wait for life saving treatment in other countries that have a national healthcare plan. I do not doubt these stories, and they are just as heartbreaking as the stories I’ve shared above. However, in the US, access and delivery of healthcare is a problem for 45 – 50 million Americans, which, in my opinion, is a disgrace.
Sources:
(1)Karen Auge, “Why costs spiral up,” Denver Post, August 23, 2009, 16A
(2)http://video.msn.com/video.aspx?mkt=en-us&vid=43fef8f9-c591-495b-9669-3f70bc85e077&fg=rss&from=34
(3)http://www.nytimes.com/2009/08/27/opinion/27kristof.html?_r=1&emc=eta1
katielapins@cis-partners.com
Disclaimer: This is Part One of a two part article on Healthcare Reform. This article represents a position for universal healthcare, tomorrow’s article presents a position against healthcare reform. We would love to hear your (constructive) feedback, so feel free to post a comment responding to either position, or both.
I would like to begin this article with my own disclaimer for the readers. There are many aspects of the current healthcare debate that I do not fully understand. I am the first to admit that I have not read the entire 1,000+ pages in the proposed bill. I also know that you can find at least one statistic to support your position on almost anything, so while I see merit in both sides of the argument, I cannot state unequivocally which is the most accurate, true or realistic.
However, to me, the debate of healthcare reform is about something entirely different. Healthcare should not be something that only working Americans enjoy. It should not be something that drives a family into bankruptcy or prevents someone from working because they will lose their Medicaid coverage. It should also not be something that bureaucrats or employees, in Washington, DC or in private insurance companies, make decisions about. It should be about having access to the best realistic treatment available for a reasonable fee.
Here are a few examples of what I’m talking about:
In the Denver Post recently, a physician in private practice was interviewed about healthcare reform (1). His daughter was diagnosed with brain cancer and when he and his wife realized they would quickly hit their maximum lifetime benefits, his wife quickly got a job with the City and County of Denver, which has an insurance benefit that does not have a lifetime maximum limit. He decided to close his practice and go to work for Kaiser Permanente, because he claimed that it offered a more sustainable model of healthcare.
An acquaintance of mine quit her job to stay home with a newly adopted child. Shortly thereafter, her husband experienced a significant mental illness which, for safety and legal reasons, meant she had to file for divorce. She was then diagnosed with a brain tumor and because of her financial situation, she qualified for Medicaid. Now that she is healthy, she would like to get a job. Unfortunately, she will not qualify for healthcare because of her pre-existing condition and lack of private insurance. She is therefore better off staying unemployed because she will then continue to qualify for Medicaid. She is willing to pay a premium to stay on Medicaid, and wants to work, but the system does not allow for this option.
An estimated 8,000 people were recently treated in Los Angeles by Regional Area Medical, a non-profit organization first designed to attend to the medical needs of developing countries. They now have waiting lines in the US wherever they go, and are often forced to turn people away (2).
At a similar event in Tennessee, an executive for Cigna realized that the care people were receiving was “in public in stalls intended for livestock.” (3) This executive, Wendell Potter, resigned from his position because he felt like he could no longer participate in a system with a goal of maximizing profits that was not benefitting its constituents.
The insurance industry is in business to maximize its return to shareholders. The more premiums an insurance company can take in and the less it has to pay out for services, the better its returns. This goal is opposite of the goal of the medical industry, which is to prevent, diagnose and treat medical problems. I understand and agree that there are perverse incentives within the medical field to run up huge bills to receive additional fees; therefore, part of any reform should be altering this system. However, I do not believe that outcomes related to these systemic issues negatively impact my treatment in the same way as would an insurance company denying treatment or approving procedures based on cost.
Many critics often claim that the US Government should not be in charge of health insurance. In case people had not noticed, it already is. The US Government administers Medicaid in conjunction with the States, and Medicare is a Federal program that, by all accounts, is extremely successful. The Public Health Service program and the healthcare provided through the Department of Veterans Affairs are also Federal programs that overall, are successful. Are they perfect? Heavens, no, but at least their goal is not the opposite of mine when it comes to my healthcare.
I would like to know what percentage of those who oppose healthcare reform do not have health insurance. How many of them turn down Medicare when they become eligible to participate? It is easy to oppose healthcare reform when you are not the one being denied access or treatment, and when you are not the one filing for bankruptcy because of the cost of treatment.
Basic healthcare is a human right. In the United States, we have the best healthcare in the world, but not the best access in the world. I have heard statistics and personal stories about people having to wait for life saving treatment in other countries that have a national healthcare plan. I do not doubt these stories, and they are just as heartbreaking as the stories I’ve shared above. However, in the US, access and delivery of healthcare is a problem for 45 – 50 million Americans, which, in my opinion, is a disgrace.
Sources:
(1)Karen Auge, “Why costs spiral up,” Denver Post, August 23, 2009, 16A
(2)http://video.msn.com/video.aspx?mkt=en-us&vid=43fef8f9-c591-495b-9669-3f70bc85e077&fg=rss&from=34
(3)http://www.nytimes.com/2009/08/27/opinion/27kristof.html?_r=1&emc=eta1
Tuesday, September 1, 2009
Gardasil May Have Some Competition
By: Grete Dudek, CIS Compliance Associate
gretedudek@cis-partners.com
A little over one year after Dana Zelig’s article “CDC and FDA Stand by Merck’s Gardasil” (1) was published on the Pharma Compliance Blog, the FDA and CDC released a statement saying that they “continue to find that Gardasil is a safe and effective vaccine.” (2) The timing of this report is interesting, because Gardasil, a Human Pappillomavirus (HPV) vaccine manufactured by Merck, and Cervarix, an HPV vaccine manufactured GlaxoSmithKline, are both going before the FDA Vaccines and Related Biological Products Advisory Committee on September 9th. (3) The Committee will be debating whether or not to expand the use of Gardasil, which is currently only recommended for females ages 9-26, to also include males. The thought is that if men are vaccinated as well, not only will they be protected from genital warts and certain cancers, they will also prevent the spread of HPV to girls and women. The second topic to be addressed by the Advisory Committee meeting is the approval of Cervarix. If Cervarix is approved, Gardasil will face competition from another HPV vaccine for the first time in U.S. markets; the drugs are currently both approved in other countries around the world.
Although the vaccines were both developed to protect against HPV, there are some notable differences between them. Gardasil is a tetravalent vaccine, meaning it contains and protects against 4 strains of HPV- two that cause 70% of cervical cancer, and two that cause 90% of genital warts. Cervarix protects against two strains, the same two most common cancer causing strains as Gardasil, but is designed with an adjuvant to promote long term anti-body production. Cervarix has also been shown to protect against the five most cervical cancer-causing strains of HPV (4), and GSK released information at the International Human Papillomavirus conference in Sweden that Cervarix “generated a significantly higher immune response (neutralising antibodies and B cells) compared to Gardasil (5)”. Gardasil, too, has been shown to protect against strains of HPV other than the four contained in the vaccine.
A second HPV vaccine entering the U.S. market might refuel the debate on whether young girls should be vaccinated. The CDC has recommended that girls as young as 11 or 12 get vaccinated, but when the states tried to make the vaccine mandatory for school entry, parents refused, saying that the vaccine could promote promiscuity. Although the vaccines are safe, there is concern that “even a rare thing may be too much of a risk (6),” especially for healthy young girls, and women who have regular Pap tests. Cervical cancer “particularly affects girls who don’t have access to health care and Pap tests, (6)” and “since 80 percent of the 280,000 cervical cancer deaths a year occur in poor countries (7),” these vaccines could be particularly valuable in developing countries. With limited access to healthcare, Pap tests or other regular cervical cancer screenings, women in developing countries are at risk for late detection of cervical cancer. The World Health Organization (WHO) has approved Gardasil and Cervarix for use in developing countries, allowing the UN and non-profit organizations to purchase and distribute the vaccines to those who need them most.
Sources:
1. http://pharmacomplianceblog.blogspot.com/2008/08/cdc-and-fda-stand-by-mercks-gardasil.html
2. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm179549.htm
3. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm178920.htm
4. http://www.fiercepharma.com/story/glaxos-cervarix-wards-more-hpv-strains/2009-07-07
5. http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10051.htm
6. http://www.nytimes.com/2009/08/19/health/research/19vaccine.html?em
7. http://www.reuters.com/article/rbssHealthcareNews/idUSL948126520090709
gretedudek@cis-partners.com
A little over one year after Dana Zelig’s article “CDC and FDA Stand by Merck’s Gardasil” (1) was published on the Pharma Compliance Blog, the FDA and CDC released a statement saying that they “continue to find that Gardasil is a safe and effective vaccine.” (2) The timing of this report is interesting, because Gardasil, a Human Pappillomavirus (HPV) vaccine manufactured by Merck, and Cervarix, an HPV vaccine manufactured GlaxoSmithKline, are both going before the FDA Vaccines and Related Biological Products Advisory Committee on September 9th. (3) The Committee will be debating whether or not to expand the use of Gardasil, which is currently only recommended for females ages 9-26, to also include males. The thought is that if men are vaccinated as well, not only will they be protected from genital warts and certain cancers, they will also prevent the spread of HPV to girls and women. The second topic to be addressed by the Advisory Committee meeting is the approval of Cervarix. If Cervarix is approved, Gardasil will face competition from another HPV vaccine for the first time in U.S. markets; the drugs are currently both approved in other countries around the world.
Although the vaccines were both developed to protect against HPV, there are some notable differences between them. Gardasil is a tetravalent vaccine, meaning it contains and protects against 4 strains of HPV- two that cause 70% of cervical cancer, and two that cause 90% of genital warts. Cervarix protects against two strains, the same two most common cancer causing strains as Gardasil, but is designed with an adjuvant to promote long term anti-body production. Cervarix has also been shown to protect against the five most cervical cancer-causing strains of HPV (4), and GSK released information at the International Human Papillomavirus conference in Sweden that Cervarix “generated a significantly higher immune response (neutralising antibodies and B cells) compared to Gardasil (5)”. Gardasil, too, has been shown to protect against strains of HPV other than the four contained in the vaccine.
A second HPV vaccine entering the U.S. market might refuel the debate on whether young girls should be vaccinated. The CDC has recommended that girls as young as 11 or 12 get vaccinated, but when the states tried to make the vaccine mandatory for school entry, parents refused, saying that the vaccine could promote promiscuity. Although the vaccines are safe, there is concern that “even a rare thing may be too much of a risk (6),” especially for healthy young girls, and women who have regular Pap tests. Cervical cancer “particularly affects girls who don’t have access to health care and Pap tests, (6)” and “since 80 percent of the 280,000 cervical cancer deaths a year occur in poor countries (7),” these vaccines could be particularly valuable in developing countries. With limited access to healthcare, Pap tests or other regular cervical cancer screenings, women in developing countries are at risk for late detection of cervical cancer. The World Health Organization (WHO) has approved Gardasil and Cervarix for use in developing countries, allowing the UN and non-profit organizations to purchase and distribute the vaccines to those who need them most.
Sources:
1. http://pharmacomplianceblog.blogspot.com/2008/08/cdc-and-fda-stand-by-mercks-gardasil.html
2. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm179549.htm
3. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm178920.htm
4. http://www.fiercepharma.com/story/glaxos-cervarix-wards-more-hpv-strains/2009-07-07
5. http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10051.htm
6. http://www.nytimes.com/2009/08/19/health/research/19vaccine.html?em
7. http://www.reuters.com/article/rbssHealthcareNews/idUSL948126520090709
Thursday, August 27, 2009
Strong Comeback for Biotech Industry
By: John Jordan, CIS Senior Compliance Associate
johnjordan@cis-partners.com
As we have all witnessed, the stock market can be a very volatile entity. We have seen numerous sectors fall in great lengths in something that has not been seen in many people’s lifetimes. One of the industries that has taken a hit is the nation’s biotechnology field. However, Biotechnology Industry Organization (BIO) and Thomson Reuters have predicted that this industry will rebound this year (3). BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. The Corporate Services business of Thomson Reuters provides a suite of solutions across the Investor Relations, Corporate Communications, and Business Intelligence functions (1).
John Craighead, Managing Director of Investor Relations and Business Development at BIO, has stated that investors had predicted by mid-year a 15% increase in the market for the biotech field. That prediction has fallen quite short to the gains it has obtained (1). In doing some research, it looks like the large comeback for the industry is partly due to the strong positive clinical trial data. Other aspects such as acquisitions, mergers, and improvements in the market sentiment have also helped in the gains by the sector (1). One aspect that is making the public cautious, though, on biotech’s gains, is that investors predicted that the overall research and developmental productivity for 2009-2011 would be much the same as the years 2006-2008.
With everything taken into account, investors remain bullish about the industry. Two-thirds of the studied participants expect biotech to outperform healthcare and 70% expect biotech to outperform the rest of the market this year (2). With this information one can say that this is quite the bounce back.
Sources:
1. http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20090812005799&newsLang=en
2. http://www.fiercebiotech.com/press-releases/biotechnology-industry-expected-rebound-according-bio-thomson-reuters-investor-percep
3. http://www.fiercebiotech.com/story/biotech-industry-shows-signs-strong-comeback/2009-08-13?utm_medium=nl&utm_source=internal
johnjordan@cis-partners.com
As we have all witnessed, the stock market can be a very volatile entity. We have seen numerous sectors fall in great lengths in something that has not been seen in many people’s lifetimes. One of the industries that has taken a hit is the nation’s biotechnology field. However, Biotechnology Industry Organization (BIO) and Thomson Reuters have predicted that this industry will rebound this year (3). BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. The Corporate Services business of Thomson Reuters provides a suite of solutions across the Investor Relations, Corporate Communications, and Business Intelligence functions (1).
John Craighead, Managing Director of Investor Relations and Business Development at BIO, has stated that investors had predicted by mid-year a 15% increase in the market for the biotech field. That prediction has fallen quite short to the gains it has obtained (1). In doing some research, it looks like the large comeback for the industry is partly due to the strong positive clinical trial data. Other aspects such as acquisitions, mergers, and improvements in the market sentiment have also helped in the gains by the sector (1). One aspect that is making the public cautious, though, on biotech’s gains, is that investors predicted that the overall research and developmental productivity for 2009-2011 would be much the same as the years 2006-2008.
With everything taken into account, investors remain bullish about the industry. Two-thirds of the studied participants expect biotech to outperform healthcare and 70% expect biotech to outperform the rest of the market this year (2). With this information one can say that this is quite the bounce back.
Sources:
1. http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20090812005799&newsLang=en
2. http://www.fiercebiotech.com/press-releases/biotechnology-industry-expected-rebound-according-bio-thomson-reuters-investor-percep
3. http://www.fiercebiotech.com/story/biotech-industry-shows-signs-strong-comeback/2009-08-13?utm_medium=nl&utm_source=internal
Tuesday, August 25, 2009
GP Forum: H.R. 3200
By: Craig Kubicek, CIS Compliance Associate
craigkubicek@cis-partners.com
On August 19, 2009 a Government Pricing monthly forum was held. The forum was led by CIS members Lauren Pellicciotti (Compliance Manager), and Chris Cobourn (Vice President of Regulatory Compliance). The topic of discussion was H.R. 3200 America's Affordable Health Choices Act of 2009. The bill was introduced by Representative John D. Dingell on July 14th 2009 and can be found online: http://www.gpo.gov/fdsys/pkg/BILLS-111hr3200IH/content-detail.html
H.R. 3200 is an extensive and comprehensive thousand page document that covers the riveting details of the current administration’s proposed solutions to America’s Health Care. As many of us know, the administration is at full-steam, pushing ahead to create a universal Health Care system that is mandatory for all American citizens. However, what many do not know or understand is the government pricing perspective of the H.R. 3200 bill. As the CIS Government Pricing forum was underway, its attendees spoke on the possible implications of the new Government Pricing changes and what might be affected and what to be expected.
In the hour the forum was held a variety of topics were touched. The conference spoke about:
o Definition in AMP (‘Other Payments’)
o Manufacturer Reporting Requirements (No later than 30 days – Added Clause)
o Disclosure of Price Information In Public (Clause Update)
o Pharmacy Reimbursements Through December 31, 2010
o Additional Rebate For New Formulations of Existing Drugs (‘S’ and ‘I’ drugs)
o Increase Minimum Rebate Percentage for Single Source Drugs (22.1%)
o Increase Minimum Rebate Percentage for Generic Drugs???
A lot of preparation will be needed in order to employ the government’s newly proposed health care overhaul. CIS and its dedicated members have already begun the needed steps of preparing. The Government Pricing forum is just another step in the right direction. Many issues are raised and constructively discussed to ensure that its members are up to date on key government pricing subjects. H.R. 3200 could be a big change for the methodologies in the Government Pricing community. The Government Pricing members are not asking themselves whether or not the new changes will work, but how can they better prepare themselves and make the transition easier.
Next on the list of subjects to discuss
craigkubicek@cis-partners.com
On August 19, 2009 a Government Pricing monthly forum was held. The forum was led by CIS members Lauren Pellicciotti (Compliance Manager), and Chris Cobourn (Vice President of Regulatory Compliance). The topic of discussion was H.R. 3200 America's Affordable Health Choices Act of 2009. The bill was introduced by Representative John D. Dingell on July 14th 2009 and can be found online: http://www.gpo.gov/fdsys/pkg/BILLS-111hr3200IH/content-detail.html
H.R. 3200 is an extensive and comprehensive thousand page document that covers the riveting details of the current administration’s proposed solutions to America’s Health Care. As many of us know, the administration is at full-steam, pushing ahead to create a universal Health Care system that is mandatory for all American citizens. However, what many do not know or understand is the government pricing perspective of the H.R. 3200 bill. As the CIS Government Pricing forum was underway, its attendees spoke on the possible implications of the new Government Pricing changes and what might be affected and what to be expected.
In the hour the forum was held a variety of topics were touched. The conference spoke about:
- The amount of money to be involved and how much of it would add to the deficit and how much would be considered revenue
- Pharmacy Reimbursement Limits:
o Definition in AMP (‘Other Payments’)
o Manufacturer Reporting Requirements (No later than 30 days – Added Clause)
o Disclosure of Price Information In Public (Clause Update)
o Pharmacy Reimbursements Through December 31, 2010
o Additional Rebate For New Formulations of Existing Drugs (‘S’ and ‘I’ drugs)
o Increase Minimum Rebate Percentage for Single Source Drugs (22.1%)
o Increase Minimum Rebate Percentage for Generic Drugs???
A lot of preparation will be needed in order to employ the government’s newly proposed health care overhaul. CIS and its dedicated members have already begun the needed steps of preparing. The Government Pricing forum is just another step in the right direction. Many issues are raised and constructively discussed to ensure that its members are up to date on key government pricing subjects. H.R. 3200 could be a big change for the methodologies in the Government Pricing community. The Government Pricing members are not asking themselves whether or not the new changes will work, but how can they better prepare themselves and make the transition easier.
Next on the list of subjects to discuss
- OMB Budget for FY 2010
- The reauthorization of SCHIP
- The extension of Medicaid rebates to Medicaid Managed Care
- Legal Immigrant Children’s Health Improvement Act of 2009
- 340B Program Improvement and Integrity Act of 2009
Monday, August 24, 2009
Fear of the Unknown: The Upcoming Flu Season
By: Suma Kallurkar, CIS Senior Compliance Manager
sumakallurkar@cis-partners.com
Every year many people worry about the flu season and faithfully obtain their flu shots in an effort to prevent or minimize illness. This year, however, anxiety over the flu has heightened significantly due to the H1N1 flu (swine flu). In the US, H1N1 flu-related illness (including hospitalizations and deaths) has continued to occur even in this summer season, which is normally flu-free. As children and parents prepare to go back to school, and other adults prepare for back-to-normal schedules at work, there is a great deal of nervousness about the H1N1 flu and the havoc it may create. The US Centers for Disease Control and Prevention (CDC) has clearly stated concerns that this flu season could be severe due to the H1N1 virus.
A vaccine for the H1N1 virus is currently in production and expected to be available in the fall. This vaccine will not be taken in lieu of the normal seasonal flu vaccine. Rather, folks who want protection against both strains of the flu will have to concurrently undergo both vaccinations. The H1N1 vaccination will probably require 2 doses spaced a few weeks apart, although some health officials are proposing that 3 doses may be required.
As often is the case, concerns exist over the quantity of the vaccine that will be produced and available. Due to the possibility of limited availability, the CDC has made recommendations on those populations that are at higher risk: pregnant women, those who care for children 6 months or younger, healthcare workers, people aged 6 months to 24 years, and people aged 25-64 years who possess health conditions that place them at greater risk of complications from the flu.
The H1N1 flu could significantly impact the workplace and business. Employers are being warned to prepare for longer absences of their employees due to H1N1 flu. No doubt the same applies for many children potentially being absent from school. A greater understanding for such absences is required, as this is what ultimately can prevent the spread of the virus. There is also a renewed emphasis on common sense activities, such as hand-washing, covering one’s mouth/nose when coughing/sneezing, and isolating oneself from contact with others.
I for one never worried about the flu much and never received a flu shot until I became pregnant. Now that I am a mother of a 4 month-old, my perspective on the flu has undoubtedly changed, as I am concerned for the well-being of my son. We all will have to be extra careful this flu season and be willing to do the little tasks, such as hand-washing, that can help prevent the spread of any flu virus. Hopefully, come the end of the flu season, we will have survived with minimal illness.
Sources:
http://www.cdc.gov/h1n1flu/vaccination/acip.htm
http://www.latimes.com/news/local/la-me-swine-flu20-2009aug20,0,4256379.story
http://www.bloomberg.com/apps/news?pid=20601103&sid=aoKnGT96tLng
sumakallurkar@cis-partners.com
Every year many people worry about the flu season and faithfully obtain their flu shots in an effort to prevent or minimize illness. This year, however, anxiety over the flu has heightened significantly due to the H1N1 flu (swine flu). In the US, H1N1 flu-related illness (including hospitalizations and deaths) has continued to occur even in this summer season, which is normally flu-free. As children and parents prepare to go back to school, and other adults prepare for back-to-normal schedules at work, there is a great deal of nervousness about the H1N1 flu and the havoc it may create. The US Centers for Disease Control and Prevention (CDC) has clearly stated concerns that this flu season could be severe due to the H1N1 virus.
A vaccine for the H1N1 virus is currently in production and expected to be available in the fall. This vaccine will not be taken in lieu of the normal seasonal flu vaccine. Rather, folks who want protection against both strains of the flu will have to concurrently undergo both vaccinations. The H1N1 vaccination will probably require 2 doses spaced a few weeks apart, although some health officials are proposing that 3 doses may be required.
As often is the case, concerns exist over the quantity of the vaccine that will be produced and available. Due to the possibility of limited availability, the CDC has made recommendations on those populations that are at higher risk: pregnant women, those who care for children 6 months or younger, healthcare workers, people aged 6 months to 24 years, and people aged 25-64 years who possess health conditions that place them at greater risk of complications from the flu.
The H1N1 flu could significantly impact the workplace and business. Employers are being warned to prepare for longer absences of their employees due to H1N1 flu. No doubt the same applies for many children potentially being absent from school. A greater understanding for such absences is required, as this is what ultimately can prevent the spread of the virus. There is also a renewed emphasis on common sense activities, such as hand-washing, covering one’s mouth/nose when coughing/sneezing, and isolating oneself from contact with others.
I for one never worried about the flu much and never received a flu shot until I became pregnant. Now that I am a mother of a 4 month-old, my perspective on the flu has undoubtedly changed, as I am concerned for the well-being of my son. We all will have to be extra careful this flu season and be willing to do the little tasks, such as hand-washing, that can help prevent the spread of any flu virus. Hopefully, come the end of the flu season, we will have survived with minimal illness.
Sources:
http://www.cdc.gov/h1n1flu/vaccination/acip.htm
http://www.latimes.com/news/local/la-me-swine-flu20-2009aug20,0,4256379.story
http://www.bloomberg.com/apps/news?pid=20601103&sid=aoKnGT96tLng
Thursday, August 20, 2009
EMEA and FDA Launching Clinical Trial Conduct Initiative
By: Jon Dellaquila, CIS Compliance Manager
jondellaquila@cis-partners.com
On August 3, 2009, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA) announced a collaborative initiative examining the conduct of clinical trials submitted in drug marketing applications. The pilot program, set to begin on September 1, 2009 and last for 18 months, will provide an opportunity for the two organizations to work together and allow for the sharing of information regarding good clinical practice (GCP) inspections conducted by the FDA and EMEA.[1] The intentions of the initiative will provide an open dialogue between the two organizations leading to a more efficient use of resources while improving the quality of clinical trials.
Facing a global economic recession, it is not surprising that some government agencies have begun assessing ideas to harmonize similar procedures. Currently, a large number of clinical trial participants come from the United States and the European Union - increasing the emphasis on why it may be important for these two organizations to work together. Since each agency operates with limited inspection resources, only a small sample of clinical trials can be inspected.[2] The scope of this program will allow for each organization to essentially double the number of inspections due to sharing of information or open the possibility of a joint inspection being performed. The key objectives of this initiative are:
To conduct periodic information exchanges on GCP-related information in order to streamline sharing of GCP inspection planning information, and to communicate timely and effectively on inspection outcomes.
To conduct collaborative GCP inspections by sharing information, experience, and inspection procedures, cooperating in the conduct of inspections, and sharing best-practice knowledge.
To share information on interpretation of GCP, by keeping each regulatory agency informed of GCP-related legislation, regulatory guidance and related documents, and act together to benefit the clinical research process.[1]
The collaborative effort will not only benefit inspectors from both agencies, but also the groups performing the clinical trials as well. The exchange of information will allow inspectors to become better informed with each organization’s inspection methods and styles; therefore, allowing the possibility to better educate the people responsible for performing the trials. At the end of the 18 months, the two agencies will evaluate the program’s success in achieving its goal of providing higher quality clinical trials.
This initiative could be the start of a more common practice among regulatory agencies. Although each agency has its own policies and procedures, they both remain rooted in the ideals of protecting patients and ensuring the highest quality of clinical trials. As the pharmaceutical industry develops new medicines, and additional developing countries begin participating in clinical trials, there is going to be an increasing need for quality inspection and oversight. A worldwide organization or panel governing clinical trial conduct may be closer than one would think.
Sources:
[1] United States. Food and Drug Administration. FDA, European Medicines Agency Launch Good Clinical Practices Initiative. 03 Aug 2009. Accessed on 19 Aug 2009.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174983.htm
[2] European Union. European Medicines Agency. EMEA-FDA GCP Initiative. 31 Jul 2009. Accessed on 19 Aug 2009 http://www.emea.europa.eu/pdfs/general/direct/internationalcoop/EMEA_FDA_GCP_Initiative_2009.pdf
jondellaquila@cis-partners.com
On August 3, 2009, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA) announced a collaborative initiative examining the conduct of clinical trials submitted in drug marketing applications. The pilot program, set to begin on September 1, 2009 and last for 18 months, will provide an opportunity for the two organizations to work together and allow for the sharing of information regarding good clinical practice (GCP) inspections conducted by the FDA and EMEA.[1] The intentions of the initiative will provide an open dialogue between the two organizations leading to a more efficient use of resources while improving the quality of clinical trials.
Facing a global economic recession, it is not surprising that some government agencies have begun assessing ideas to harmonize similar procedures. Currently, a large number of clinical trial participants come from the United States and the European Union - increasing the emphasis on why it may be important for these two organizations to work together. Since each agency operates with limited inspection resources, only a small sample of clinical trials can be inspected.[2] The scope of this program will allow for each organization to essentially double the number of inspections due to sharing of information or open the possibility of a joint inspection being performed. The key objectives of this initiative are:
To conduct periodic information exchanges on GCP-related information in order to streamline sharing of GCP inspection planning information, and to communicate timely and effectively on inspection outcomes.
To conduct collaborative GCP inspections by sharing information, experience, and inspection procedures, cooperating in the conduct of inspections, and sharing best-practice knowledge.
To share information on interpretation of GCP, by keeping each regulatory agency informed of GCP-related legislation, regulatory guidance and related documents, and act together to benefit the clinical research process.[1]
The collaborative effort will not only benefit inspectors from both agencies, but also the groups performing the clinical trials as well. The exchange of information will allow inspectors to become better informed with each organization’s inspection methods and styles; therefore, allowing the possibility to better educate the people responsible for performing the trials. At the end of the 18 months, the two agencies will evaluate the program’s success in achieving its goal of providing higher quality clinical trials.
This initiative could be the start of a more common practice among regulatory agencies. Although each agency has its own policies and procedures, they both remain rooted in the ideals of protecting patients and ensuring the highest quality of clinical trials. As the pharmaceutical industry develops new medicines, and additional developing countries begin participating in clinical trials, there is going to be an increasing need for quality inspection and oversight. A worldwide organization or panel governing clinical trial conduct may be closer than one would think.
Sources:
[1] United States. Food and Drug Administration. FDA, European Medicines Agency Launch Good Clinical Practices Initiative. 03 Aug 2009. Accessed on 19 Aug 2009.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174983.htm
[2] European Union. European Medicines Agency. EMEA-FDA GCP Initiative. 31 Jul 2009. Accessed on 19 Aug 2009 http://www.emea.europa.eu/pdfs/general/direct/internationalcoop/EMEA_FDA_GCP_Initiative_2009.pdf
Wednesday, August 19, 2009
Sharing Prescription Drugs Frequent Among U.S. Teens
By: Kerri McCutchin, CIS Compliance Associate
kerrimccutchin@cis-partners.com
Prescription drug abuse by teens and young adults has spiraled into a serious issue in the United States. As reported in the Partnership for a Drug Free America’s annual tracking study:
The study, which appears online in the Journal of Adolescent Health, interviewed 592 English and Spanish speaking adolescents, ages 12 to 17, both black and white. The teens were asked if they had ever “borrowed” or “loaned” a prescription drug and, if so, what kind. The teens were also asked if they ever gave or received any warnings or instructions with the medication. Questions concerning outcomes were also raised, such as did the person taking the drugs visit a doctor anyway? Did side effects or allergic reactions occur [2]? Chris Mayhorn, an associate professor of psychology at North Carolina State University, states in a news release from the Center for the Advancement of Health:
According to lead author Richard Goldsworthy, Director for Research and Development at Academic Edge, Inc., and colleagues, the study found that nearly a third of teens who took a "borrowed" prescription did not inform their doctors. This type of situation can lead to unexpected drug interactions [1]. In addition to the risk of unforeseen side effects, prescription drug sharing can lead to a delay in teens addressing serious health care issues. Teens may skip necessary appointments believing they have already dealt with the problem. Moreover, the misuse of shared antibiotics enhances the increasing problem of antibiotic drug resistance [2].
The findings within the study are important "for physicians, prevention coalitions, school counselors, parents and the youth themselves," said Melissa Haddow, co-author of the study and director of the Community Partnership of the Ozarks. She continues by stating, "this work adds to our knowledge about a growing problem….and highlights the diversity of medications being abused this way, which had not been recognized.”
Sources:
[1] http://news.yahoo.com/s/hsn/20090810/hl_hsn/sharingprescriptionmedscommonamongusteens
[2] http://www.news-medical.net/news/20090810/Sharing-prescription-advice-among-adolescents-can-have-dangerous-repercussions.aspx
[3] http://www.drugfree.org/portal/drugissue/features/prescription_medicine_misuse
kerrimccutchin@cis-partners.com
Prescription drug abuse by teens and young adults has spiraled into a serious issue in the United States. As reported in the Partnership for a Drug Free America’s annual tracking study:
- 1 in 5 teens has abused a prescription (Rx) pain medication
- 1 in 5 report abusing prescription stimulants and tranquilizers
- 1 in 10 has abused cough medication [3]
The study, which appears online in the Journal of Adolescent Health, interviewed 592 English and Spanish speaking adolescents, ages 12 to 17, both black and white. The teens were asked if they had ever “borrowed” or “loaned” a prescription drug and, if so, what kind. The teens were also asked if they ever gave or received any warnings or instructions with the medication. Questions concerning outcomes were also raised, such as did the person taking the drugs visit a doctor anyway? Did side effects or allergic reactions occur [2]? Chris Mayhorn, an associate professor of psychology at North Carolina State University, states in a news release from the Center for the Advancement of Health:
"Other researchers have studied people selling prescription drugs, but we looked
at people with good intentions, trying, for instance, to help a friend who
lacked money or transportation for a doctor's visit" [1].
According to lead author Richard Goldsworthy, Director for Research and Development at Academic Edge, Inc., and colleagues, the study found that nearly a third of teens who took a "borrowed" prescription did not inform their doctors. This type of situation can lead to unexpected drug interactions [1]. In addition to the risk of unforeseen side effects, prescription drug sharing can lead to a delay in teens addressing serious health care issues. Teens may skip necessary appointments believing they have already dealt with the problem. Moreover, the misuse of shared antibiotics enhances the increasing problem of antibiotic drug resistance [2].
The findings within the study are important "for physicians, prevention coalitions, school counselors, parents and the youth themselves," said Melissa Haddow, co-author of the study and director of the Community Partnership of the Ozarks. She continues by stating, "this work adds to our knowledge about a growing problem….and highlights the diversity of medications being abused this way, which had not been recognized.”
Sources:
[1] http://news.yahoo.com/s/hsn/20090810/hl_hsn/sharingprescriptionmedscommonamongusteens
[2] http://www.news-medical.net/news/20090810/Sharing-prescription-advice-among-adolescents-can-have-dangerous-repercussions.aspx
[3] http://www.drugfree.org/portal/drugissue/features/prescription_medicine_misuse
Tuesday, August 18, 2009
Fact: The Color Blue Can Heal Spinal Injuries
By: Lauren Pellicciotti, CIS Compliance Manager
laurenpellicciotti@cis-partners.com
Prior to starting my full day at work, I like to enjoy a cup of Joe at my kitchen table while watching the morning news. Now you might be wondering how this might relate to health care industry news. Well, during my morning routine, I could not believe my ears when I heard that blue M&Ms and Gatorade could help people with long-term spinal injuries[1].
According to a study conducted by the University of Rochester Medical Center, the compound Brilliant Blue G can potentially prevent the cascade of events that leads to inflammation of the spine that usually is followed by a traumatic event[2]. According to Dr. Steven Goldman, who worked on the study, "We have no effective treatment now for patients who have an acute spinal cord injury. Our hope is that this work will lead to a practical, safe agent that can be given to patients shortly after injury, for the purpose of decreasing the secondary damage that we have to otherwise expect."
Proceedings of the National Academy of the Sciences states that inflammation can cause more irreversible damage than the initial trauma. Maiken Nedergaard of the University of Rochester Medical Center and colleagues reported that “One of the chemicals is ATP. Nedergaard's team looked for something that would interfere with this and found the blue dye, which they called BBG, would do this via the P2X7R receptor or doorway. The team found that IV administration of the P2X7R inhibitor BBG significantly reduced the severity of spinal cord damage without any evident toxicity. Remarkably, BBG is a derivative of the widely used food additive FD&C Blue number 1. Currently, more than 1 million pounds of FD&C blue dye No. 1 are consumed yearly in the United States, corresponding to a daily intake of 16 mg per person1.”
Knowing that small bit of information and the probability of this helping a person in need, I will definitely keep this information in my back pocket as a home remedy, as should you! If nothing else, a little chocolate might cheer you up.
Sources:
[1] Blue Food Dye Used in M&M's May Treat Spinal Cord Injuries: http://www.foxnews.com/story/0,2933,535142,00.html
[2] WebMD News: http://www.webmd.com/brain/news/20090729/blue-dye-mms-helps-spinal-cord-injuries
laurenpellicciotti@cis-partners.com
Prior to starting my full day at work, I like to enjoy a cup of Joe at my kitchen table while watching the morning news. Now you might be wondering how this might relate to health care industry news. Well, during my morning routine, I could not believe my ears when I heard that blue M&Ms and Gatorade could help people with long-term spinal injuries[1].
According to a study conducted by the University of Rochester Medical Center, the compound Brilliant Blue G can potentially prevent the cascade of events that leads to inflammation of the spine that usually is followed by a traumatic event[2]. According to Dr. Steven Goldman, who worked on the study, "We have no effective treatment now for patients who have an acute spinal cord injury. Our hope is that this work will lead to a practical, safe agent that can be given to patients shortly after injury, for the purpose of decreasing the secondary damage that we have to otherwise expect."
Proceedings of the National Academy of the Sciences states that inflammation can cause more irreversible damage than the initial trauma. Maiken Nedergaard of the University of Rochester Medical Center and colleagues reported that “One of the chemicals is ATP. Nedergaard's team looked for something that would interfere with this and found the blue dye, which they called BBG, would do this via the P2X7R receptor or doorway. The team found that IV administration of the P2X7R inhibitor BBG significantly reduced the severity of spinal cord damage without any evident toxicity. Remarkably, BBG is a derivative of the widely used food additive FD&C Blue number 1. Currently, more than 1 million pounds of FD&C blue dye No. 1 are consumed yearly in the United States, corresponding to a daily intake of 16 mg per person1.”
Knowing that small bit of information and the probability of this helping a person in need, I will definitely keep this information in my back pocket as a home remedy, as should you! If nothing else, a little chocolate might cheer you up.
Sources:
[1] Blue Food Dye Used in M&M's May Treat Spinal Cord Injuries: http://www.foxnews.com/story/0,2933,535142,00.html
[2] WebMD News: http://www.webmd.com/brain/news/20090729/blue-dye-mms-helps-spinal-cord-injuries
Thursday, August 13, 2009
Over-the-Counter
By: Jordan Mummau, CIS Compliance Associate
jordanmummau@cis-partners.com
To be honest, it took me until I was about 16 to figure out that over-the-counter drugs in any particular pharmacy were never really behind a counter to begin with. Back then, I assumed that a pharmacist had to hand you the product over a physical counter to be qualified as an over-the-counter drug (which is ironic because this would more closely describe the process for obtaining prescription drugs). Is this common? Unfortunately, I doubt it; I would assume most people understand the difference between the term “over-the-counter” and the act of physically passing something over a counter. At 16, I also seemed to share the more mainstream problem of understanding the difference between 10:00pm and 1:00am. I was told to be home at 10:00pm, which I naturally assumed was equivalent to 1:00am. But I digress…
I am pleased to announce that I have come a long way since then. I am older, debatably wiser, and more prone to balding and accidental falls. I am also able to wrap my head around the figurative over-the-counter process, having acquired an understanding of the FDA approval process drugs must go through in order to make it to pharmacy shelves.
The incentives of manufacturing over the counter (OTC) products versus prescription drugs are obvious. Manufacturers are able to market their products directly to consumers (DTC advertising), which allows for increased sales and profits[1]. This also alleviates extra spending on sales reps to visit and educate physicians on prescribing their medications, the side effects of these drugs, and ways to promote the drugs, all things pharmaceutical companies often have to do to foster awareness of their prescription drugs[2]. DTC advertising allows companies to lower the retail prices on their OTC drugs, and provides access to a larger market than physicians alone would be able to expose them to.
However, in order for a drug to be sold over the counter, it must meet the criteria established by the FDA. Over the years, the FDA has made amendment after amendment to the original Food, Drug, and Cosmetic Act of 1938, which was the first piece of legislation to require that drugs be cleared by the U.S. Food and Drug Administration before they could be marketed for human use. In 1951, an amendment was made to the Act which established the distinction between prescription and non-prescription drugs. In short, this amendment basically stated that if a drug product was unable to be labeled with accurate instructions on how to use it safely, it was to be available by prescription only. Another amendment was added in 1962, requiring OTC drugs to be effective for their intended uses[3].
In more recent years, the FDA has used a reclassification process in order to allow products previously indicated as prescription drugs to be sold as non-prescription drugs. There are three ways this change can be administered. (1) The FDA itself is allowed to file a petition for reclassification if it is determined that prescription status is not required for the safe use of the drug. (2) If new clinical research provides information that allows a drug to be approved for an OTC indication or at OTC dosage levels, a New Drug Application (NDA) may be filed by the manufacturer. (3) A supplement to the original NDA may be filed if favorable post marketing safety experience for a product provides evidence that the drug product may be safely used without the supervision of a physician[4].
While there are also several specific drug approval regulations, including formulation, chronic treatments, etc., hopefully this article will assist you in understanding that the phrase over-the-counter should not necessarily be taken literally.
Three OTC Quick Facts[5]:
[1] Dessen, Moses, and Rossitto. "Information About Over-The-Counter Drugs Malpractice." DMS-Lawyers. 28 May 2006. Web. 31 July 2009. http://www.dms-lawyer.com/area/otc.shtml
[2] Dessen, Moses, and Rossitto. "Information About Over-The-Counter Drugs Malpractice." DMS-Lawyers. 28 May 2006. Web. 31 July 2009. http://www.dms-lawyer.com/area/otc.shtml
[3] Jacobs, Lori R. "Prescription to Over-the-Counter Drug Reclassification." American Family Physician. The Medicine Shoppe. Web. 31 July 2009. http://www.aafp.org/afp/980501ap/jacobs.html
[4] Jacobs, Lori R. "Prescription to Over-the-Counter Drug Reclassification." American Family Physician. The Medicine Shoppe. Web. 31 July 2009. http://www.aafp.org/afp/980501ap/jacobs.html
[5] Jacobs, Lori R. "Prescription to Over-the-Counter Drug Reclassification." American Family Physician. The Medicine Shoppe. Web. 31 July 2009. http://www.aafp.org/afp/980501ap/jacobs.html
Additional Sources:
Cohen, Joshua P., Cherie Paquette, and Catherine P. Cairns. "Switching Prescription Drugs to Over-the-Counter." BMJ. 1 Jan. 2005. Web. 31 July 2009. http://www.bmj.com/cgi/content/full/330/7481/39
"Office of Nonprescription Products." FDA US Food and Drug Administration. U.S. Department of Health and Human Services. Web. 31 July 2009. http://www.fda.gov/AboutFDA/CentersOffices/cder/ucm093452.htm
jordanmummau@cis-partners.com
To be honest, it took me until I was about 16 to figure out that over-the-counter drugs in any particular pharmacy were never really behind a counter to begin with. Back then, I assumed that a pharmacist had to hand you the product over a physical counter to be qualified as an over-the-counter drug (which is ironic because this would more closely describe the process for obtaining prescription drugs). Is this common? Unfortunately, I doubt it; I would assume most people understand the difference between the term “over-the-counter” and the act of physically passing something over a counter. At 16, I also seemed to share the more mainstream problem of understanding the difference between 10:00pm and 1:00am. I was told to be home at 10:00pm, which I naturally assumed was equivalent to 1:00am. But I digress…
I am pleased to announce that I have come a long way since then. I am older, debatably wiser, and more prone to balding and accidental falls. I am also able to wrap my head around the figurative over-the-counter process, having acquired an understanding of the FDA approval process drugs must go through in order to make it to pharmacy shelves.
The incentives of manufacturing over the counter (OTC) products versus prescription drugs are obvious. Manufacturers are able to market their products directly to consumers (DTC advertising), which allows for increased sales and profits[1]. This also alleviates extra spending on sales reps to visit and educate physicians on prescribing their medications, the side effects of these drugs, and ways to promote the drugs, all things pharmaceutical companies often have to do to foster awareness of their prescription drugs[2]. DTC advertising allows companies to lower the retail prices on their OTC drugs, and provides access to a larger market than physicians alone would be able to expose them to.
However, in order for a drug to be sold over the counter, it must meet the criteria established by the FDA. Over the years, the FDA has made amendment after amendment to the original Food, Drug, and Cosmetic Act of 1938, which was the first piece of legislation to require that drugs be cleared by the U.S. Food and Drug Administration before they could be marketed for human use. In 1951, an amendment was made to the Act which established the distinction between prescription and non-prescription drugs. In short, this amendment basically stated that if a drug product was unable to be labeled with accurate instructions on how to use it safely, it was to be available by prescription only. Another amendment was added in 1962, requiring OTC drugs to be effective for their intended uses[3].
In more recent years, the FDA has used a reclassification process in order to allow products previously indicated as prescription drugs to be sold as non-prescription drugs. There are three ways this change can be administered. (1) The FDA itself is allowed to file a petition for reclassification if it is determined that prescription status is not required for the safe use of the drug. (2) If new clinical research provides information that allows a drug to be approved for an OTC indication or at OTC dosage levels, a New Drug Application (NDA) may be filed by the manufacturer. (3) A supplement to the original NDA may be filed if favorable post marketing safety experience for a product provides evidence that the drug product may be safely used without the supervision of a physician[4].
While there are also several specific drug approval regulations, including formulation, chronic treatments, etc., hopefully this article will assist you in understanding that the phrase over-the-counter should not necessarily be taken literally.
Three OTC Quick Facts[5]:
- Non-prescription drugs account for 60 percent of all medications used in the United States.
- Criteria that allow a prescription drug to be reclassified as an OTC drug include the following: similar indications for both prescription and nonprescription uses, easy diagnosis and monitoring by the patient, and favorable adverse-effect and drug-interaction profiles.
- Switching a product from prescription to over-the-counter status permits the drug manufacturer to market the product for several more years without generic competition.
[1] Dessen, Moses, and Rossitto. "Information About Over-The-Counter Drugs Malpractice." DMS-Lawyers. 28 May 2006. Web. 31 July 2009. http://www.dms-lawyer.com/area/otc.shtml
[2] Dessen, Moses, and Rossitto. "Information About Over-The-Counter Drugs Malpractice." DMS-Lawyers. 28 May 2006. Web. 31 July 2009. http://www.dms-lawyer.com/area/otc.shtml
[3] Jacobs, Lori R. "Prescription to Over-the-Counter Drug Reclassification." American Family Physician. The Medicine Shoppe. Web. 31 July 2009. http://www.aafp.org/afp/980501ap/jacobs.html
[4] Jacobs, Lori R. "Prescription to Over-the-Counter Drug Reclassification." American Family Physician. The Medicine Shoppe. Web. 31 July 2009. http://www.aafp.org/afp/980501ap/jacobs.html
[5] Jacobs, Lori R. "Prescription to Over-the-Counter Drug Reclassification." American Family Physician. The Medicine Shoppe. Web. 31 July 2009. http://www.aafp.org/afp/980501ap/jacobs.html
Additional Sources:
Cohen, Joshua P., Cherie Paquette, and Catherine P. Cairns. "Switching Prescription Drugs to Over-the-Counter." BMJ. 1 Jan. 2005. Web. 31 July 2009. http://www.bmj.com/cgi/content/full/330/7481/39
"Office of Nonprescription Products." FDA US Food and Drug Administration. U.S. Department of Health and Human Services. Web. 31 July 2009. http://www.fda.gov/AboutFDA/CentersOffices/cder/ucm093452.htm
Wednesday, August 12, 2009
The Definition of Indecent Could Become Ridiculous
By: Judy Fox, CIS Senior Compliance Manager
judyfox@cis-partners.com
On April 29, 2009 State Representative James P. Moran of Virginia introduced a bill – H.R. 2175 into the House of Representatives with the official title, “To prohibit as indecent the broadcasting of any advertisement for a medication for the treatment of erectile dysfunction[ED], and for other purposes.” The short title for the bill as it was introduced is the “Families for ED Advertising Decency Act.” The bill is co-sponsored by Representative Robert A. Brady of Pennsylvania. The title of the bill alone sounded a little ridiculous, but I had to read it to make sure. The bill is not lengthy or wordy, nor does it contain a lot of legal terminology, yet to me, the content is just as confusing.
The bill asks that the Federal Communications Commission (FCC) revise the enforcement policies relating to indecent material so that radio and television stations would be prohibited from broadcasting any advertisements for ED any day between 6am and 10 pm. The bill asks that stations treat all advertisements for ED medication as indecent. Yup, that’s right, INDECENT. The restriction would not include product placement, or the mention of the trademarked or generic name for an ED medication.
There is a possibility that I am missing something, but is the reason why all ads for ED medications are being deemed indecent is because ED is a medical condition that has to do with male genitalia? Or is it because the only reason to take the medication is to have sex? Either way, I find it ridiculous to define indecent in this way.
I tried to recall the ads I have seen for these products and could not remember ever seeing one that I felt was even inappropriate, let alone indecent. I did recall some that were confusing. I remember one in particular where a couple was sitting in separate outdoor bathtubs overlooking the beach. I found it a bit silly, but certainly not indecent. I didn’t want to rely on my memory alone, so I did a little unscientific research. The ads I found showed what appeared to be monogamous couples, usually appearing to be in their 50’s, smiling at each other, dancing, and, in general, enjoying each other. I couldn’t find a single ad that featured people having sex. None of the ads I viewed (in my very unscientific research) did more than imply the indication of the medication. There was the often joked about four hour erection warning, but most direct to consumer (DTC) advertising can cause one to cringe when the possible side effects are rattled off anyway.
The only thing I could conclude was that the indication for these medications must be the cause behind labeling the ads as ‘indecent’. It may be news to Representatives Moran and Brady, but I think I can speak for most couples when I say that sex is a healthy part of a relationship. I can’t find anything indecent about the fact that there are plenty of men who have a medical condition that keep them from being able to enjoy sex with their partners. Many sufferers are embarrassed to seek help for the condition, and labeling the advertisements offering them help as indecent could make them feel even worse. Removing the stigma associated with the problem has made it easier for men to seek help from their doctors and avoid purchasing knock-offs and questionable products through mail order companies.
Furthermore, pharmaceutical marketing teams work hard to target DTC advertising to the appropriate audiences, and place their advertisements during programs that appeal to those target audiences. As such, ED ads are not aired during children’s programming, or during programs that target teen audiences. If the representatives are worried about decency, they should concentrate on ad placement in general, or, and this is a novel concept, on the content of the programming itself. For example, when my sons were young, I remember actually getting angry at the commercials for R-rated movies that were aired during family programming. I would consider that inappropriate, not indecent mind you, just inappropriate and possibly worth looking into. I think we have so many more important issues to worry about before we should target happy, dancing couples.
The way the bill reads, it would be acceptable for a television program to make Viagra® jokes, have Cialis® logos plastered all over the side of a car, or feature Levitra® as a sponsor, but there couldn’t be a commercial for those products during the same program. Ridiculous. What’s next? Banning ads for birth-control pills? After all, these politicians might erroneously reason, only women who have sex need the Pill.
Sources:
http://thomas.loc.gov/cgi-bin/bdquery/D?d111:14:./temp/~bdQWzr:@@@T
www.viagra.com
www.levitra.com
www.cialis.com
judyfox@cis-partners.com
On April 29, 2009 State Representative James P. Moran of Virginia introduced a bill – H.R. 2175 into the House of Representatives with the official title, “To prohibit as indecent the broadcasting of any advertisement for a medication for the treatment of erectile dysfunction[ED], and for other purposes.” The short title for the bill as it was introduced is the “Families for ED Advertising Decency Act.” The bill is co-sponsored by Representative Robert A. Brady of Pennsylvania. The title of the bill alone sounded a little ridiculous, but I had to read it to make sure. The bill is not lengthy or wordy, nor does it contain a lot of legal terminology, yet to me, the content is just as confusing.
The bill asks that the Federal Communications Commission (FCC) revise the enforcement policies relating to indecent material so that radio and television stations would be prohibited from broadcasting any advertisements for ED any day between 6am and 10 pm. The bill asks that stations treat all advertisements for ED medication as indecent. Yup, that’s right, INDECENT. The restriction would not include product placement, or the mention of the trademarked or generic name for an ED medication.
There is a possibility that I am missing something, but is the reason why all ads for ED medications are being deemed indecent is because ED is a medical condition that has to do with male genitalia? Or is it because the only reason to take the medication is to have sex? Either way, I find it ridiculous to define indecent in this way.
I tried to recall the ads I have seen for these products and could not remember ever seeing one that I felt was even inappropriate, let alone indecent. I did recall some that were confusing. I remember one in particular where a couple was sitting in separate outdoor bathtubs overlooking the beach. I found it a bit silly, but certainly not indecent. I didn’t want to rely on my memory alone, so I did a little unscientific research. The ads I found showed what appeared to be monogamous couples, usually appearing to be in their 50’s, smiling at each other, dancing, and, in general, enjoying each other. I couldn’t find a single ad that featured people having sex. None of the ads I viewed (in my very unscientific research) did more than imply the indication of the medication. There was the often joked about four hour erection warning, but most direct to consumer (DTC) advertising can cause one to cringe when the possible side effects are rattled off anyway.
The only thing I could conclude was that the indication for these medications must be the cause behind labeling the ads as ‘indecent’. It may be news to Representatives Moran and Brady, but I think I can speak for most couples when I say that sex is a healthy part of a relationship. I can’t find anything indecent about the fact that there are plenty of men who have a medical condition that keep them from being able to enjoy sex with their partners. Many sufferers are embarrassed to seek help for the condition, and labeling the advertisements offering them help as indecent could make them feel even worse. Removing the stigma associated with the problem has made it easier for men to seek help from their doctors and avoid purchasing knock-offs and questionable products through mail order companies.
Furthermore, pharmaceutical marketing teams work hard to target DTC advertising to the appropriate audiences, and place their advertisements during programs that appeal to those target audiences. As such, ED ads are not aired during children’s programming, or during programs that target teen audiences. If the representatives are worried about decency, they should concentrate on ad placement in general, or, and this is a novel concept, on the content of the programming itself. For example, when my sons were young, I remember actually getting angry at the commercials for R-rated movies that were aired during family programming. I would consider that inappropriate, not indecent mind you, just inappropriate and possibly worth looking into. I think we have so many more important issues to worry about before we should target happy, dancing couples.
The way the bill reads, it would be acceptable for a television program to make Viagra® jokes, have Cialis® logos plastered all over the side of a car, or feature Levitra® as a sponsor, but there couldn’t be a commercial for those products during the same program. Ridiculous. What’s next? Banning ads for birth-control pills? After all, these politicians might erroneously reason, only women who have sex need the Pill.
Sources:
http://thomas.loc.gov/cgi-bin/bdquery/D?d111:14:./temp/~bdQWzr:@@@T
www.viagra.com
www.levitra.com
www.cialis.com
Friday, August 7, 2009
My name is Steven P. Moore and I haven’t smoked in 5 years.
By: Steven Moore, CIS Director of Business Development
stevenmoore@cis-partners.com
Given the industry we work in, I thought that this topic was pertinent. I thank you in advance for reading my story.
I was recently at a gas station in my hometown of Belford, NJ and saw a sign for Newport cigarettes. They were selling for $6.66. I snapped a picture with my cell phone and had planned on using it for this blog article, but my phone zonked out recently and I lost the photo. So I’ll allow you to imagine the fun irony of putting that price tag on a pack of cigarettes…
On August 22, 2004, my wife-to-be and girlfriend at the time, brought over a bag full of goodies. But these weren’t just any goodies --- the bag contained just about every possible quit smoking aid that she could research: Twizzlers, lollipops, toothpicks, etc. The bag was overflowing. She had never asked me to quit but let’s be honest, who wants to kiss a smoker and who wants someone that you care about to smoke?
I had set my quit date for August 23, 2004 a couple months earlier. I think if there is one event that prompted me to say enough is enough (besides wanting to do it for my health and for my wife-to-be) it was a ‘date’ that we had a couple months prior. We had been going out for a month or two and went for a LONG run at Fairmount Park in Philadelphia. I had smoked since I was about 18 and at that time, at 25, this was no joy run for me! But, being the man that I am, I ran with a smile and as soon as I could find a quiet place to cough up a lung…I did so! The saddest part was that I was somewhat of an athlete through high school and college --- but it was clear now that 7 years of coffin nails were starting to take their toll.
So the morning of August 23rd came and I drove into work with my coffee and, for the first time in 5 years, did not have a cigarette. Now here’s one of the more ironic and twisted stories I’ve ever been able to re-tell. As I was driving in that morning, there was a road crew on a local road near my work that was ‘re-tarring’ the road. The crew waived me through and I thought I’d be fine. Well, the tar was still wet and splashed all over my car. So the two pieces of irony are, on the day I intended to quit smoking: 1) My car was covered in TAR. 2) I had an event happen that would usually make me reach for a pack of cigarettes --- not just one. I didn’t smoke then and haven’t smoked since.
My wife recently asked me, “What’s the best part about not smoking?” I didn’t hesitate when I answered, “You know, it’s when we go for our daily runs together and I pass someone on a bench who is smoking.” That may sound strange, but I think when you’re doing something so fundamentally opposite to something harmful, it’s an invigorating feeling. Of course I feel for those who still smoke as I breeze past, but I’m thankful for getting the strength from God, family and friends to get through it.
Quitting smoking was the best decision I’ve ever made, next to asking my wife for her hand in marriage and joining CIS (what a kiss up!). For those of you who are smoking and want to quit, know that you CAN do it. It is possible, and when you do quit, you will feel amazing. Your fingers go from yellow to normal. Your teeth get whiter. You can run. You can keep up with your kids. You can dance. You can hike. You can imagine a future without coughing every morning and every time you run up stairs. You can be proud of it. You can (and should) tell everyone. You can write an article like this one day. You can say that you’re stronger than a tobacco-filled piece of paper.
You can use the gum, the patch, medicine, etc. But I can guarantee you this: The strongest quit smoking aid is your own will power. Remember back to a time when there was something you wanted so badly and you achieved it. Remember how you felt. Find that power and voice and I’m certain you can quit! I registered on www.njquitnet.com, a fantastic site for assistance, and they keep a running tab of certain key stats. As of me typing this article, these were my stats:
My Stats:
Your Quit Date is: 8/23/2004 1:30:00 PM
Time Smoke-Free: 1,805 days, 21 hours, 52 minutes and 32 seconds
Cigarettes NOT smoked: 36,118
Lifetime Saved: 9 months, 5 days, 21 hours
Money Saved: $7,314.30
More than 36,000 cigarettes! Wow! My efforts have allowed me 9 more months of life to breathe, to be with my wife and, God-willing, children and grandchildren. The amount of MONEY that I saved has paid for 3 vacations --- including our honeymoon! What can you do with $7,314.30 over the course of 5 years?
My lone wish in writing this article is that it may just inspire one person to put the cigarettes down and go for it. This isn’t about me bragging about what I’ve been able to do --- it’s about trying to help through words and, for the first time in my life, I have a public forum to do so! I went through it and understand the strength it takes and the feelings you’ll experience. Heck, if this makes you want to quit, call or email me when you’re struggling and I’ll have your back. Do it with a loved one or a friend who wants to quit with you or cares for you. They’ll help. They’ll take walks with you. They’ll stay on the phone with you. They’ll give you a hug when it hurts. They’ll break a cigarette in half and flush it.
And, if you’re lucky enough, they might even bring you a bag overflowing with quit-smoking aids to help you quit.
No wonder my username on NJ Quitnet is:
Quit4Her.
I thank you and love you Noreen.
For your space,
Steven.
stevenmoore@cis-partners.com
Given the industry we work in, I thought that this topic was pertinent. I thank you in advance for reading my story.
I was recently at a gas station in my hometown of Belford, NJ and saw a sign for Newport cigarettes. They were selling for $6.66. I snapped a picture with my cell phone and had planned on using it for this blog article, but my phone zonked out recently and I lost the photo. So I’ll allow you to imagine the fun irony of putting that price tag on a pack of cigarettes…
On August 22, 2004, my wife-to-be and girlfriend at the time, brought over a bag full of goodies. But these weren’t just any goodies --- the bag contained just about every possible quit smoking aid that she could research: Twizzlers, lollipops, toothpicks, etc. The bag was overflowing. She had never asked me to quit but let’s be honest, who wants to kiss a smoker and who wants someone that you care about to smoke?
I had set my quit date for August 23, 2004 a couple months earlier. I think if there is one event that prompted me to say enough is enough (besides wanting to do it for my health and for my wife-to-be) it was a ‘date’ that we had a couple months prior. We had been going out for a month or two and went for a LONG run at Fairmount Park in Philadelphia. I had smoked since I was about 18 and at that time, at 25, this was no joy run for me! But, being the man that I am, I ran with a smile and as soon as I could find a quiet place to cough up a lung…I did so! The saddest part was that I was somewhat of an athlete through high school and college --- but it was clear now that 7 years of coffin nails were starting to take their toll.
So the morning of August 23rd came and I drove into work with my coffee and, for the first time in 5 years, did not have a cigarette. Now here’s one of the more ironic and twisted stories I’ve ever been able to re-tell. As I was driving in that morning, there was a road crew on a local road near my work that was ‘re-tarring’ the road. The crew waived me through and I thought I’d be fine. Well, the tar was still wet and splashed all over my car. So the two pieces of irony are, on the day I intended to quit smoking: 1) My car was covered in TAR. 2) I had an event happen that would usually make me reach for a pack of cigarettes --- not just one. I didn’t smoke then and haven’t smoked since.
My wife recently asked me, “What’s the best part about not smoking?” I didn’t hesitate when I answered, “You know, it’s when we go for our daily runs together and I pass someone on a bench who is smoking.” That may sound strange, but I think when you’re doing something so fundamentally opposite to something harmful, it’s an invigorating feeling. Of course I feel for those who still smoke as I breeze past, but I’m thankful for getting the strength from God, family and friends to get through it.
Quitting smoking was the best decision I’ve ever made, next to asking my wife for her hand in marriage and joining CIS (what a kiss up!). For those of you who are smoking and want to quit, know that you CAN do it. It is possible, and when you do quit, you will feel amazing. Your fingers go from yellow to normal. Your teeth get whiter. You can run. You can keep up with your kids. You can dance. You can hike. You can imagine a future without coughing every morning and every time you run up stairs. You can be proud of it. You can (and should) tell everyone. You can write an article like this one day. You can say that you’re stronger than a tobacco-filled piece of paper.
You can use the gum, the patch, medicine, etc. But I can guarantee you this: The strongest quit smoking aid is your own will power. Remember back to a time when there was something you wanted so badly and you achieved it. Remember how you felt. Find that power and voice and I’m certain you can quit! I registered on www.njquitnet.com, a fantastic site for assistance, and they keep a running tab of certain key stats. As of me typing this article, these were my stats:
My Stats:
Your Quit Date is: 8/23/2004 1:30:00 PM
Time Smoke-Free: 1,805 days, 21 hours, 52 minutes and 32 seconds
Cigarettes NOT smoked: 36,118
Lifetime Saved: 9 months, 5 days, 21 hours
Money Saved: $7,314.30
More than 36,000 cigarettes! Wow! My efforts have allowed me 9 more months of life to breathe, to be with my wife and, God-willing, children and grandchildren. The amount of MONEY that I saved has paid for 3 vacations --- including our honeymoon! What can you do with $7,314.30 over the course of 5 years?
My lone wish in writing this article is that it may just inspire one person to put the cigarettes down and go for it. This isn’t about me bragging about what I’ve been able to do --- it’s about trying to help through words and, for the first time in my life, I have a public forum to do so! I went through it and understand the strength it takes and the feelings you’ll experience. Heck, if this makes you want to quit, call or email me when you’re struggling and I’ll have your back. Do it with a loved one or a friend who wants to quit with you or cares for you. They’ll help. They’ll take walks with you. They’ll stay on the phone with you. They’ll give you a hug when it hurts. They’ll break a cigarette in half and flush it.
And, if you’re lucky enough, they might even bring you a bag overflowing with quit-smoking aids to help you quit.
No wonder my username on NJ Quitnet is:
Quit4Her.
I thank you and love you Noreen.
For your space,
Steven.
Monday, August 3, 2009
Is Pay-for-Delay Here to Stay?
By: Kyle Hodgin, CIS Compliance Associate
kylehodgin@cis-partners.com
In a blow to consumer rights activists and insurance companies, the Supreme Court recently declined to hear a case concerning the pay-for-delay practices made possible under the Hatch-Waxman Act of 1984. The absence of a ruling by the high court translates into secured profitability for branded pharmaceutical manufacturers, and possibly slower availability of generic alternatives to branded drugs for consumers. The decision by the courts to pass on hearing the case perpetuates the existing system under the Act and continues to raise questions in the minds of lobbyists and consumers alike such as; does the public have a right to cheaper generic drugs, and do manufacturers have a right to prolong protection of proprietary materials and information in light of increasing costs for branded meds?
The so-called, “pay-for-delay” practice has become a divisive issue between manufacturers and consumer activists. The practice involves a payment from branded drug makers to generic manufacturers to simply hold off on production as an alternative to enduring patent infringement litigation. The deal provides the generic companies with a substantial amount of cash with relatively little expenditure and the branded makers with a prolonged period of exclusive market share for that particular product. Critics cite the practice as anticompetitive as it prevents other generic manufacturers from entering the market. The Hatch-Waxman Act allows the first generic manufacturer to win FDA approval, for a generic version of a branded drug, 180 days of exclusivity. This provision was intended to incentivize competing generic makers to invest in the necessary tests to achieve bio-equivalency with assurance of recuperating those costs once the drug was approved. However, branded manufacturers have instead offered cash incentives to these generic companies to refrain from bringing the product to market for a specified period of time, in which case other generic companies are unable to obtain FDA approval for that particular product.
The payments, called reverse settlements, have insurance companies and consumer groups on edge, because they view the agreements as collusion, ultimately ending in a significantly higher price to the consumer; however, some generic drug makers and branded companies claim the agreements have multiple benefits to companies and consumers alike. When generic firms apply for an Abbreviated New Drug Application (ANDA), they are required to establish that the patent for the branded product is expired or invalid, and to notify the patent holder of the submission of the ANDA. Under the Act, branded companies are able to file a patent infringement suit within 45 days of the submission of the ANDA, and consequently, the courts must immediately enact a stay of up to 30 months to review the patent and determine if any infringement has occurred, during which time the generic firm may not market the contested product. This may effectively provide the branded manufacturer with up to two and a half additional years of exclusive market share that far outweighs the cost of infringement litigation. During the initial stay, the company has the opportunity to file a secondary patent on the original drug that, if granted, provides another opportunity for the manufacturer to file an infringement suit against the generic maker, thereby opening the door for further stays perpetuating exclusive marketing rights for the branded maker. The reverse settlement agreement is viewed as a means to avoid litigation, which can be costly for generic manufacturers as they often do not possess the same financial means as their branded counterparts. By not continuing the litigation, branded and generic firms can possibly bypass the lengthy stays that are enacted while the courts decide on the infringement suit.
Branded drug companies also cite the agreement as another method to protect property that took years, and tremendous amounts of capital, to develop. With the cost of bringing a single successful drug to market hovering around 800 million dollars and 8-12 years of development, manufacturers look to plow a significant portion of earnings from their branded products into research and development budgets. Some are concerned that further attempts to redefine patent laws will see a shortage in these crucial investments that could ultimately lead to a lesser quality of life for the general public in years to come. The Supreme Court’s decision to pass on hearing the latest case involving pay-to-delay practices means consumer groups and insurance companies may have to look to reform of the Hatch-Waxman Act or a change in patent laws to effectively bring an end to this practice.
Sources:
http://www.fiercepharma.com/story/supremes-wont-revew-pay-delay-case/2009-06-23
http://knowledge.wharton.upenn.edu/article.cfm?articleid=575
http://www.law.duke.edu/journals/dltr/articles/2003dltr0018.html
http://www.unav.es/english/news/105.html
kylehodgin@cis-partners.com
In a blow to consumer rights activists and insurance companies, the Supreme Court recently declined to hear a case concerning the pay-for-delay practices made possible under the Hatch-Waxman Act of 1984. The absence of a ruling by the high court translates into secured profitability for branded pharmaceutical manufacturers, and possibly slower availability of generic alternatives to branded drugs for consumers. The decision by the courts to pass on hearing the case perpetuates the existing system under the Act and continues to raise questions in the minds of lobbyists and consumers alike such as; does the public have a right to cheaper generic drugs, and do manufacturers have a right to prolong protection of proprietary materials and information in light of increasing costs for branded meds?
The so-called, “pay-for-delay” practice has become a divisive issue between manufacturers and consumer activists. The practice involves a payment from branded drug makers to generic manufacturers to simply hold off on production as an alternative to enduring patent infringement litigation. The deal provides the generic companies with a substantial amount of cash with relatively little expenditure and the branded makers with a prolonged period of exclusive market share for that particular product. Critics cite the practice as anticompetitive as it prevents other generic manufacturers from entering the market. The Hatch-Waxman Act allows the first generic manufacturer to win FDA approval, for a generic version of a branded drug, 180 days of exclusivity. This provision was intended to incentivize competing generic makers to invest in the necessary tests to achieve bio-equivalency with assurance of recuperating those costs once the drug was approved. However, branded manufacturers have instead offered cash incentives to these generic companies to refrain from bringing the product to market for a specified period of time, in which case other generic companies are unable to obtain FDA approval for that particular product.
The payments, called reverse settlements, have insurance companies and consumer groups on edge, because they view the agreements as collusion, ultimately ending in a significantly higher price to the consumer; however, some generic drug makers and branded companies claim the agreements have multiple benefits to companies and consumers alike. When generic firms apply for an Abbreviated New Drug Application (ANDA), they are required to establish that the patent for the branded product is expired or invalid, and to notify the patent holder of the submission of the ANDA. Under the Act, branded companies are able to file a patent infringement suit within 45 days of the submission of the ANDA, and consequently, the courts must immediately enact a stay of up to 30 months to review the patent and determine if any infringement has occurred, during which time the generic firm may not market the contested product. This may effectively provide the branded manufacturer with up to two and a half additional years of exclusive market share that far outweighs the cost of infringement litigation. During the initial stay, the company has the opportunity to file a secondary patent on the original drug that, if granted, provides another opportunity for the manufacturer to file an infringement suit against the generic maker, thereby opening the door for further stays perpetuating exclusive marketing rights for the branded maker. The reverse settlement agreement is viewed as a means to avoid litigation, which can be costly for generic manufacturers as they often do not possess the same financial means as their branded counterparts. By not continuing the litigation, branded and generic firms can possibly bypass the lengthy stays that are enacted while the courts decide on the infringement suit.
Branded drug companies also cite the agreement as another method to protect property that took years, and tremendous amounts of capital, to develop. With the cost of bringing a single successful drug to market hovering around 800 million dollars and 8-12 years of development, manufacturers look to plow a significant portion of earnings from their branded products into research and development budgets. Some are concerned that further attempts to redefine patent laws will see a shortage in these crucial investments that could ultimately lead to a lesser quality of life for the general public in years to come. The Supreme Court’s decision to pass on hearing the latest case involving pay-to-delay practices means consumer groups and insurance companies may have to look to reform of the Hatch-Waxman Act or a change in patent laws to effectively bring an end to this practice.
Sources:
http://www.fiercepharma.com/story/supremes-wont-revew-pay-delay-case/2009-06-23
http://knowledge.wharton.upenn.edu/article.cfm?articleid=575
http://www.law.duke.edu/journals/dltr/articles/2003dltr0018.html
http://www.unav.es/english/news/105.html
Thursday, July 30, 2009
Who is Responsible for Acetaminophen Use?
By Jon Dellaquila, CIS Senior Compliance Associate
jondellaquila@cis-partners.com
Recently the Food and Drug Administration (FDA) received several recommendations from its advisory committee regarding the use of acetaminophen, due to the drug’s ability to potentially cause liver failure. The suggestions offered by the advisory committee include lowering dosage amounts, removing acetaminophen from products that contain other medications, and requiring a black box warning.[1] The scope of this decision and its effect on the general public may be surprisingly large. The products affected include the popular pain killers Tylenol and Excedrin, as well as a variety of cold medicines. Although the FDA does not have to follow the advisory committee’s recommendations, it consistently does. The FDA will more than likely implement a few changes regarding the consumer’s ability to obtain products containing acetaminophen in order to promote safety. However, these products, and the FDA’s regulation of them, may not be the true problem.
The FDA is limited in its ability to inform consumers about the use of any medications, food or drink they choose to consume. It does have the ability to approve and remove products from market, limit the dosage amounts of medications, and require package inserts to be included with them in the hopes of keeping patients informed. However, once the products hit the market shelves and are available over the counter or as prescribed by a physician, the consumers become responsible for their own well being. Patient responsibility may be the root of the acetaminophen issue. The FDA can require acetaminophen doses be lowered from 500 mg to 325 mg in a single pill, and the maximum daily doses be lowered from 4,000 mg to 2,600 mg, but that cannot prevent someone from ingesting more pills to reach the 4,000 mg level if they choose to do so.[2] Regardless of the dosage of acetaminophen contained in any product, the patient will still have the ability to overdose on the medication.
The black box warning for products containing acetaminophen may be the most effective tool in alerting patients that there is concern about their safety when taking any of these medications. It is also possible that the FDA will begin requiring the sale of acetaminophen products behind the counter, as was done with medicines containing pseudoephedrine due to the Combat Methamphetamine Epidemic Act of 2005.[3] Although these two drugs would be sold behind the counter for different reasons, doing so would provide one additional opportunity for the patient to be informed by a pharmacist about the use of acetaminophen.
The FDA does an admirable job of ensuring patient safety, but its power is limited. The ultimate responsibility lies with the consumer. People need to be aware that anything they choose to ingest will impact their health and their body in one way or another. Consumers should do their best to stay well informed, and be aware of what they eat and what medicines they take. So, as a consumer and concerned citizen, please remember to be aware of any medications you may be taking, as well as their dosages. When in doubt, do not hesitate to call your physician or speak to a pharmacist prior to taking any medication.
Sources:
[1]Foxhall, Kathryn. “FDA May Restrict Acetaminophen.” WebMD. 01 Jul 2009. Accessed: 13 Jul 2009.
http://www.webmd.com/pain-management/news/20090701/fda-may-restrict-acetaminophen?page=2
[2]Beck, Melinda. “Taking Pains With a Painkiller.” Wall Street Journal. 10 Jul 2009. Accessed: 13 Jul 2009.
http://online.wsj.com/article/SB10001424052970203577304574272292331942618.html?mod=googlenews_wsj
[3] Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine. Food and Drug Administration. 25 Apr 2006. Accessed: 13 Jul 2009
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm072423.htm
jondellaquila@cis-partners.com
Recently the Food and Drug Administration (FDA) received several recommendations from its advisory committee regarding the use of acetaminophen, due to the drug’s ability to potentially cause liver failure. The suggestions offered by the advisory committee include lowering dosage amounts, removing acetaminophen from products that contain other medications, and requiring a black box warning.[1] The scope of this decision and its effect on the general public may be surprisingly large. The products affected include the popular pain killers Tylenol and Excedrin, as well as a variety of cold medicines. Although the FDA does not have to follow the advisory committee’s recommendations, it consistently does. The FDA will more than likely implement a few changes regarding the consumer’s ability to obtain products containing acetaminophen in order to promote safety. However, these products, and the FDA’s regulation of them, may not be the true problem.
The FDA is limited in its ability to inform consumers about the use of any medications, food or drink they choose to consume. It does have the ability to approve and remove products from market, limit the dosage amounts of medications, and require package inserts to be included with them in the hopes of keeping patients informed. However, once the products hit the market shelves and are available over the counter or as prescribed by a physician, the consumers become responsible for their own well being. Patient responsibility may be the root of the acetaminophen issue. The FDA can require acetaminophen doses be lowered from 500 mg to 325 mg in a single pill, and the maximum daily doses be lowered from 4,000 mg to 2,600 mg, but that cannot prevent someone from ingesting more pills to reach the 4,000 mg level if they choose to do so.[2] Regardless of the dosage of acetaminophen contained in any product, the patient will still have the ability to overdose on the medication.
The black box warning for products containing acetaminophen may be the most effective tool in alerting patients that there is concern about their safety when taking any of these medications. It is also possible that the FDA will begin requiring the sale of acetaminophen products behind the counter, as was done with medicines containing pseudoephedrine due to the Combat Methamphetamine Epidemic Act of 2005.[3] Although these two drugs would be sold behind the counter for different reasons, doing so would provide one additional opportunity for the patient to be informed by a pharmacist about the use of acetaminophen.
The FDA does an admirable job of ensuring patient safety, but its power is limited. The ultimate responsibility lies with the consumer. People need to be aware that anything they choose to ingest will impact their health and their body in one way or another. Consumers should do their best to stay well informed, and be aware of what they eat and what medicines they take. So, as a consumer and concerned citizen, please remember to be aware of any medications you may be taking, as well as their dosages. When in doubt, do not hesitate to call your physician or speak to a pharmacist prior to taking any medication.
Sources:
[1]Foxhall, Kathryn. “FDA May Restrict Acetaminophen.” WebMD. 01 Jul 2009. Accessed: 13 Jul 2009.
http://www.webmd.com/pain-management/news/20090701/fda-may-restrict-acetaminophen?page=2
[2]Beck, Melinda. “Taking Pains With a Painkiller.” Wall Street Journal. 10 Jul 2009. Accessed: 13 Jul 2009.
http://online.wsj.com/article/SB10001424052970203577304574272292331942618.html?mod=googlenews_wsj
[3] Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine. Food and Drug Administration. 25 Apr 2006. Accessed: 13 Jul 2009
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm072423.htm
Wednesday, July 29, 2009
FDA Orders Stronger Warning Placed on Labels of Drugs Containing Propoxyphene
By: Kerri McCutchin, CIS Compliance Associate
kerrimccutchin@cis-partners.com
The Food and Drug Administration (FDA) has recently ordered manufacturers to place stronger warning labels on the prescription pain killer propoxyphene, commonly known as Darvon or Darvocet. Action has been taken due evidence of fatal overdoses, both accidental and intentional, involving propoxyphene. In Europe, recent data indicates that this medication could possbily be more lethal in overdose than other pain medications [5]. Propoxyphene has been on the market since 1957, and is an opiate commonly prescribed to relieve mild to moderate pain [4]. The most frequent side effects of propoxyphene include lightheadedness, dizziness, sedation, nausea, and vomiting [3].
Despite lobbying intended to eliminate propoxyphene from the market, the FDA has concluded at this time that the benefits of propoxyphene for pain relief at recommended doses outweigh the safety risks. Thus, the FDA is not suggesting the removal of propoxyphene products from the U.S. market [5]. Instead, the FDA will require manufacturers of propoxyphene to strengthen their labels by placing a boxed warning on each package, emphasizing the possible risks. Manufacturers are also required to provide consumers with a medication guide, highlighting the importance of using the drug as directed [2]. Furthermore, the FDA has required manufacturers to study higher than expected fatality rates in propoxyphene overdoses, versus those caused by other painkillers, as well as possible toxic effects on the heart when consumers exceed recommended doses [3].
More specifically, the following studies are in the planning process:
Lastly, the FDA noted that it also plans to continue to evaluate the safety of propoxyphene and will take additional and immediate regulatory action if necessary [4].
Sources
[1] http://www.rxlist.com/darvon-drug.htm
[2] http://www.consumeraffairs.com/news04/2009/07/fda_darvon.html
[3] http://abcnews.go.com/Health/PainManagement/Story?id=8027102&page=1
[4] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170769.htm
[5] http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm170268.htm
kerrimccutchin@cis-partners.com
The Food and Drug Administration (FDA) has recently ordered manufacturers to place stronger warning labels on the prescription pain killer propoxyphene, commonly known as Darvon or Darvocet. Action has been taken due evidence of fatal overdoses, both accidental and intentional, involving propoxyphene. In Europe, recent data indicates that this medication could possbily be more lethal in overdose than other pain medications [5]. Propoxyphene has been on the market since 1957, and is an opiate commonly prescribed to relieve mild to moderate pain [4]. The most frequent side effects of propoxyphene include lightheadedness, dizziness, sedation, nausea, and vomiting [3].
Despite lobbying intended to eliminate propoxyphene from the market, the FDA has concluded at this time that the benefits of propoxyphene for pain relief at recommended doses outweigh the safety risks. Thus, the FDA is not suggesting the removal of propoxyphene products from the U.S. market [5]. Instead, the FDA will require manufacturers of propoxyphene to strengthen their labels by placing a boxed warning on each package, emphasizing the possible risks. Manufacturers are also required to provide consumers with a medication guide, highlighting the importance of using the drug as directed [2]. Furthermore, the FDA has required manufacturers to study higher than expected fatality rates in propoxyphene overdoses, versus those caused by other painkillers, as well as possible toxic effects on the heart when consumers exceed recommended doses [3].
More specifically, the following studies are in the planning process:
- The FDA is working with CMS to study the safety and prescribing patterns of propoxyphene among the elderly. Notably, the FDA will look at the rates of fatalities and hip fractures among elderly patients taking propoxyphene, and compare these rates to those in elderly persons taking other analgesics.
- The FDA plans to discuss a study examining the safety of propoxyphene with the Veterans Administration, using the VA's databases.
- The FDA is planning to examine the safety of propoxyphene with one or more of its epidemiology contractors (Vanderbilt University, Kaiser - California, the HMO Research Network at Harvard Pilgrim Health, and Ingenix).
- Lastly, the FDA will examine the possibility of reviewing Medical Examiner data in the Substance Abuse and Mental Health Administration’s (SAMSHA) Drug Abuse Warning Network (DAWN) [5].
“Physicians need to be aware of the risk of overdose when prescribing these
drugs. They should carefully review patient histories and make appropriate
treatment decisions based on the warnings and directions stated within the
drug’s label. Prescribers and patients should be aware of propoxyphene’s
potential risks when used at doses higher than those recommended. Therefore, the
FDA is requiring manufacturers to provide more information to help physicians
and patients decide whether propoxyphene is the appropriate pain therapy.” [4]
Lastly, the FDA noted that it also plans to continue to evaluate the safety of propoxyphene and will take additional and immediate regulatory action if necessary [4].
Sources
[1] http://www.rxlist.com/darvon-drug.htm
[2] http://www.consumeraffairs.com/news04/2009/07/fda_darvon.html
[3] http://abcnews.go.com/Health/PainManagement/Story?id=8027102&page=1
[4] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170769.htm
[5] http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm170268.htm
Tuesday, July 28, 2009
This Year's Flu Vaccines
By: Suzanne Tavares, CIS Compliance Director
suzannetavares@cis-partners.com
This year, flu season will be a different event. It is the first time in history that officials will be recommending two different flu vaccines, both available on different schedules. One vaccine will be for the H1N1 “swine flu” virus, and the second will be for the seasonal flu. The H1N1 virus was declared a pandemic on June 11 of this year. It closed hundreds of schools across the country. Barbara Ferrer, executive direct of the Boston Public Health Commission, said one in every 10 Boston school children were affected by the H1N1 virus.
Health officials predict that swine flu season will begin earlier than the traditional flu season. They expect H1N1 to break out in September instead of the regular October/November timeframe. Even though it is summer and the traditional flu season has ended, swine flu is still around in the US, especially in summer camps. “We expect challenges when people return to school, when kids are congregating together,” Dr. Anne Schuchat, director of respiratory diseases at the Centers for Disease Control and Prevention, stated in a telephone news conference last week. The goal of public health officials is to develop and administer the swine vaccine early, especially to school age children. This group and the elderly are particularly susceptible to this strain.
However, manufacturing the swine flu vaccine has its challenges, and the clock is ticking. The government shipped the H1N1 seed strain to vaccine manufactures in May. The H1N1 flu strain is growing between 25-50% slower than the seasonal H1N1 flu strain, but manufacturers are trying different methods to speed up the growth. Last week, Australia initiated clinical trials for the vaccine; in the US, the FDA will have only weeks to decide if the vaccine is safe.
What can you do to stay healthy as we wait for these vaccines? The CDC has published the following recommendations:
http://www.cdc.gov/h1n1flu/
http://www.nytimes.com/2009/07/18/health/18flu.html
http://www.npr.org/templates/story/story.php?storyId=106848740
http://www.npr.org/templates/story/story.php?storyId=106662735
suzannetavares@cis-partners.com
This year, flu season will be a different event. It is the first time in history that officials will be recommending two different flu vaccines, both available on different schedules. One vaccine will be for the H1N1 “swine flu” virus, and the second will be for the seasonal flu. The H1N1 virus was declared a pandemic on June 11 of this year. It closed hundreds of schools across the country. Barbara Ferrer, executive direct of the Boston Public Health Commission, said one in every 10 Boston school children were affected by the H1N1 virus.
Health officials predict that swine flu season will begin earlier than the traditional flu season. They expect H1N1 to break out in September instead of the regular October/November timeframe. Even though it is summer and the traditional flu season has ended, swine flu is still around in the US, especially in summer camps. “We expect challenges when people return to school, when kids are congregating together,” Dr. Anne Schuchat, director of respiratory diseases at the Centers for Disease Control and Prevention, stated in a telephone news conference last week. The goal of public health officials is to develop and administer the swine vaccine early, especially to school age children. This group and the elderly are particularly susceptible to this strain.
However, manufacturing the swine flu vaccine has its challenges, and the clock is ticking. The government shipped the H1N1 seed strain to vaccine manufactures in May. The H1N1 flu strain is growing between 25-50% slower than the seasonal H1N1 flu strain, but manufacturers are trying different methods to speed up the growth. Last week, Australia initiated clinical trials for the vaccine; in the US, the FDA will have only weeks to decide if the vaccine is safe.
What can you do to stay healthy as we wait for these vaccines? The CDC has published the following recommendations:
- Stay informed. The CDC Website is updated as information becomes available.
- Cover your nose and mouth with a tissue when you need to cough or sneeze, and throw the tissue in the trash after you use it. (The flu is spread mainly from person to person through the coughing or sneezing of infected people.)
- Wash your hands with soap and water.
- Avoid touching your eyes, nose or mouth, which spreads germs.
- Stay home from school or work if you are sick, and limit your contact with others.
- Follow public health advice on school closures, and avoid crowds.
- Find healthy ways to deal with stress.
http://www.cdc.gov/h1n1flu/
http://www.nytimes.com/2009/07/18/health/18flu.html
http://www.npr.org/templates/story/story.php?storyId=106848740
http://www.npr.org/templates/story/story.php?storyId=106662735
Monday, July 27, 2009
The Cost of Non-Compliance within the Pharmaceutical Industry
By: Karen Brown, Senior Director, Marketing
karenbrown@cis-partners.com
In a time when congress is seeking more scrutiny through stringent audits of its own government bail-out programs, words like transparency and accountability are becoming colloquial favorites of corporate leadership.
One example is a recent full page letter that GM has placed in papers around the globe, promising customers that they are making fundamental changes from top to bottom. The letter went on to provide a website to track their progress on this commitment.[1]
When we think about a similar strategy for the pharmaceutical industry, we need to pause and consider all of the areas that are impacted: patient, shareholder, community, organization, and determine whether the solution lies in corporate candor or in fundamental changes – top to bottom.
Let’s start by examining two areas where non-compliance has the most impact:
First, there is patient non-compliance. where it is estimated that 70% of all prescriptions are never consumed and 20% of all new drug prescriptions are never filled the first time. This costs US Pharma nearly $30 billion a year in lost revenue. And, most serious, the loss of 125,000 lives each year.[2]
Second, achieving regulatory compliance is crucial and costly; non-compliance can lead to imprisonment, large fines, product recalls or delays in product approval, reputational harm and plant shutdowns.
One extreme example is a large pharmaceutical manufacturer that recently paid nearly $1.5 billion in fines for marketing one of its drugs for uses not approved by the FDA; the Justice Department called this the "largest criminal fine for an individual corporation ever imposed in the United States.”[3]
So what do we really know about the cost of non-compliance, and where does pharma begin to address these issues? One approach may be to start seeking answers to some serious compliance questions:
Having a corporate compliance office or implementing one may not solve the issues surrounding patient medication compliance, but it’s a start by showing corporate responsibility, visibility and accountability.
Perhaps GM is on to something. We may see the demise of some historic auto brands, but if they hold true to their commitment to not just rebuild the company, but to reinvent it, we may see an industry that is smarter, leaner, faster and more focused on the customer.
Sources:
1. The Financial Times, June 5 2009 http://www.ft.com/home/us
2. http://social.eyeforpharma.com/story/real-cost-patient-non-adherence
3. http://money.cnn.com/2009/01/15/news/companies/eli_lilly/
4. http://www.medicalnewstoday.com/articles/127236.php
karenbrown@cis-partners.com
In a time when congress is seeking more scrutiny through stringent audits of its own government bail-out programs, words like transparency and accountability are becoming colloquial favorites of corporate leadership.
One example is a recent full page letter that GM has placed in papers around the globe, promising customers that they are making fundamental changes from top to bottom. The letter went on to provide a website to track their progress on this commitment.[1]
When we think about a similar strategy for the pharmaceutical industry, we need to pause and consider all of the areas that are impacted: patient, shareholder, community, organization, and determine whether the solution lies in corporate candor or in fundamental changes – top to bottom.
Let’s start by examining two areas where non-compliance has the most impact:
First, there is patient non-compliance. where it is estimated that 70% of all prescriptions are never consumed and 20% of all new drug prescriptions are never filled the first time. This costs US Pharma nearly $30 billion a year in lost revenue. And, most serious, the loss of 125,000 lives each year.[2]
Second, achieving regulatory compliance is crucial and costly; non-compliance can lead to imprisonment, large fines, product recalls or delays in product approval, reputational harm and plant shutdowns.
One extreme example is a large pharmaceutical manufacturer that recently paid nearly $1.5 billion in fines for marketing one of its drugs for uses not approved by the FDA; the Justice Department called this the "largest criminal fine for an individual corporation ever imposed in the United States.”[3]
So what do we really know about the cost of non-compliance, and where does pharma begin to address these issues? One approach may be to start seeking answers to some serious compliance questions:
- Do we know what our total cost of compliance is?
- Do we understand where we may be exposed to non-compliance risks, and at what level?
- Do we have the visibility to see how one compliance issue impacts another?
- Do we have the infrastructure to manage a corporate compliance department across the organization?
Having a corporate compliance office or implementing one may not solve the issues surrounding patient medication compliance, but it’s a start by showing corporate responsibility, visibility and accountability.
Perhaps GM is on to something. We may see the demise of some historic auto brands, but if they hold true to their commitment to not just rebuild the company, but to reinvent it, we may see an industry that is smarter, leaner, faster and more focused on the customer.
Sources:
1. The Financial Times, June 5 2009 http://www.ft.com/home/us
2. http://social.eyeforpharma.com/story/real-cost-patient-non-adherence
3. http://money.cnn.com/2009/01/15/news/companies/eli_lilly/
4. http://www.medicalnewstoday.com/articles/127236.php
Thursday, July 23, 2009
Not What the Doctor Ordered
By: Aimee Hummel, CIS Compliance Manager
aimeehummel@cis-partners.com
With today’s rising healthcare costs, the use of generic drugs has increased dramatically. This is mainly due to the significant cost savings of using generics; for some consumers it can add up to savings of $1,000 a year. Over the last 10 years, generics have saved consumers $734 billion nationwide, according to a report issued in May by the Generic Pharmaceutical Association. [i]
Although the savings are a substantial benefit, there are certain practices being adopted by insurance and prescription drug companies that have demonstrated serious risks. These practices are known as generic and therapeutic substitution, or switching, both of which may cause dangerous health risks and have caused a serious debate in the healthcare industry. Generic substitution is the practice of switching a brand name medication with another medication that is bioequivalent. Therapeutic substitution involves replacing your prescription medication with a different medication – which is often chemically different but expected to have the same clinical effect. [ii]
The problems related to these practices have occurred due to the fact that even though the substituted drugs are considered very similar, they may not be as effective, can have new or different side effects, and may have dangerous interactions with other medications, supplements or food. And making matters worse, the fact that the doctors who prescribe the medicines are not informed of the substitution, increases the risks.
The article referenced below tells a story where a child was given a generic drug used to treat epilepsy even though her doctor wrote “Dispense as Written” on the script. The medication she was initially prescribed had been effectively controlling her seizures. However, after switching to the generic medication, the child suffered 21 seizures that week. [i]
http://www.freep.com/article/20090608/BUSINESS06/906080329/
Since the cost savings show such a huge benefit, yet the risks cause serious concern, it is evident why this has become a heated debate. It seems to me that the best way to remedy the potential risk is to have rules and regulations around drug substitution. Several states have bills in their legislatures, yet no laws have been passed. If there were regulations that required the prescribing doctor’s consent before any changes were made, the potential risk would decrease.
Drug substitution doesn’t necessarily lead to negative outcomes like side effects, decreased efficacy, or dangerous interactions with other substances. “In fact, it is possible that switching to a new medication can result in fewer side effects, better efficacy, and lower costs,” says Sally Greenburg, executive director for the National Consumers League.” [ii]
Consumers must be conscious of their prescriptions and be careful when they are given a substitution. I believe we should have a say in our own healthcare and we must be aware of potential risks.
A helpful resource regarding Drug Substitution information and recommendations by The World Medical Association can be found at the following site: http://www.wma.net/e/policy/d13.htm [iii]
Sources:
[i] http://www.freep.com/article/20090608/BUSINESS06/906080329/
[ii] http://www.sheknows.com/articles/806389.htm
[iii] http://www.wma.net/e/policy/d13.htm
[iv] http://www.ncbi.nlm.nih.gov/pubmed/3731208
[v] http://www.therightprescription.org/site/second/drug_debate
[vi] http://www.epilepsymichigan.org/template.php?pid=96
aimeehummel@cis-partners.com
With today’s rising healthcare costs, the use of generic drugs has increased dramatically. This is mainly due to the significant cost savings of using generics; for some consumers it can add up to savings of $1,000 a year. Over the last 10 years, generics have saved consumers $734 billion nationwide, according to a report issued in May by the Generic Pharmaceutical Association. [i]
Although the savings are a substantial benefit, there are certain practices being adopted by insurance and prescription drug companies that have demonstrated serious risks. These practices are known as generic and therapeutic substitution, or switching, both of which may cause dangerous health risks and have caused a serious debate in the healthcare industry. Generic substitution is the practice of switching a brand name medication with another medication that is bioequivalent. Therapeutic substitution involves replacing your prescription medication with a different medication – which is often chemically different but expected to have the same clinical effect. [ii]
The problems related to these practices have occurred due to the fact that even though the substituted drugs are considered very similar, they may not be as effective, can have new or different side effects, and may have dangerous interactions with other medications, supplements or food. And making matters worse, the fact that the doctors who prescribe the medicines are not informed of the substitution, increases the risks.
The article referenced below tells a story where a child was given a generic drug used to treat epilepsy even though her doctor wrote “Dispense as Written” on the script. The medication she was initially prescribed had been effectively controlling her seizures. However, after switching to the generic medication, the child suffered 21 seizures that week. [i]
http://www.freep.com/article/20090608/BUSINESS06/906080329/
Since the cost savings show such a huge benefit, yet the risks cause serious concern, it is evident why this has become a heated debate. It seems to me that the best way to remedy the potential risk is to have rules and regulations around drug substitution. Several states have bills in their legislatures, yet no laws have been passed. If there were regulations that required the prescribing doctor’s consent before any changes were made, the potential risk would decrease.
Drug substitution doesn’t necessarily lead to negative outcomes like side effects, decreased efficacy, or dangerous interactions with other substances. “In fact, it is possible that switching to a new medication can result in fewer side effects, better efficacy, and lower costs,” says Sally Greenburg, executive director for the National Consumers League.” [ii]
Consumers must be conscious of their prescriptions and be careful when they are given a substitution. I believe we should have a say in our own healthcare and we must be aware of potential risks.
A helpful resource regarding Drug Substitution information and recommendations by The World Medical Association can be found at the following site: http://www.wma.net/e/policy/d13.htm [iii]
Sources:
[i] http://www.freep.com/article/20090608/BUSINESS06/906080329/
[ii] http://www.sheknows.com/articles/806389.htm
[iii] http://www.wma.net/e/policy/d13.htm
[iv] http://www.ncbi.nlm.nih.gov/pubmed/3731208
[v] http://www.therightprescription.org/site/second/drug_debate
[vi] http://www.epilepsymichigan.org/template.php?pid=96
Wednesday, July 22, 2009
Paging Dr. iPhone
By: Chris Didizian, CIS Senior Associate
chrisdidizian@cis-partners.com
Skimming through the Pharma news, as I tend to do early in the morning, I stumbled on an article that linked the pharma industry with the iPhone. Being somewhat of a technology geek, I read on. With Apple’s recent release of its new generation iPhone 3G(S), a powerful tool capable of managing any of roughly 35,000 applications (apps), the possibilities are endless. In fact, users will soon be able to track vital signs, blood pressure, and glucose levels through their iPhones.[1] Through presentations and marketing, Apple has made it very obvious that it will help incorporate medical information and devices with consumer electronics (the iPhone). It follows that if drugmakers were to fully utilize a popular device like the iPhone, then naturally it would extend their marketing efforts into this realm.
Currently, there exist “more than 500 medical apps, mainly used by health professionals for things such as checking normal lab values, which allow interpretation of test results… and looking up definitions of medical terms.”[2] Looking at this quotation with the “big picture viewpoint,” it would be easy to make the assumption that it’s only a matter of time before drugmakers develop an app that can suggest drugs based on specific symptoms or direct users to certain physicians within their area. If my assumption is not convincing enough, then take into consideration that one drugmaker is currently developing an app to act as a glucometer – Apple sees this example as an opportunity to further expand into the vast medical field.[3] Of course, this app is one you must pay for. How long before the iPhone can measure cholesterol, or even begin to diagnose diseases based on symptoms input by the user?
Moving forward it will be interesting to see what guidelines the FDA will publish regarding these apps, but I wouldn’t hold my breath (just last month an overdue guidance regarding risk information in promotional materials was posted). Until then, it can be expected that any instruction on the appropriate use of these apps will need to be extrapolated from untitled and warning letters.
Sources:
[1] http://www.ihe-online.com/index.php?id=2565&tx_ttnews%5Btt_news%5D=483&cHash=65536
[2] Ibid.
[3] Ibid.
chrisdidizian@cis-partners.com
Skimming through the Pharma news, as I tend to do early in the morning, I stumbled on an article that linked the pharma industry with the iPhone. Being somewhat of a technology geek, I read on. With Apple’s recent release of its new generation iPhone 3G(S), a powerful tool capable of managing any of roughly 35,000 applications (apps), the possibilities are endless. In fact, users will soon be able to track vital signs, blood pressure, and glucose levels through their iPhones.[1] Through presentations and marketing, Apple has made it very obvious that it will help incorporate medical information and devices with consumer electronics (the iPhone). It follows that if drugmakers were to fully utilize a popular device like the iPhone, then naturally it would extend their marketing efforts into this realm.
Currently, there exist “more than 500 medical apps, mainly used by health professionals for things such as checking normal lab values, which allow interpretation of test results… and looking up definitions of medical terms.”[2] Looking at this quotation with the “big picture viewpoint,” it would be easy to make the assumption that it’s only a matter of time before drugmakers develop an app that can suggest drugs based on specific symptoms or direct users to certain physicians within their area. If my assumption is not convincing enough, then take into consideration that one drugmaker is currently developing an app to act as a glucometer – Apple sees this example as an opportunity to further expand into the vast medical field.[3] Of course, this app is one you must pay for. How long before the iPhone can measure cholesterol, or even begin to diagnose diseases based on symptoms input by the user?
Moving forward it will be interesting to see what guidelines the FDA will publish regarding these apps, but I wouldn’t hold my breath (just last month an overdue guidance regarding risk information in promotional materials was posted). Until then, it can be expected that any instruction on the appropriate use of these apps will need to be extrapolated from untitled and warning letters.
Sources:
[1] http://www.ihe-online.com/index.php?id=2565&tx_ttnews%5Btt_news%5D=483&cHash=65536
[2] Ibid.
[3] Ibid.
Monday, July 20, 2009
The Affordable Healthcare Choices Act
By: Scott Hoffman, CIS Senior Associate
scotthoffman@cis-partners.com
On June 9, 2009 a draft copy of the Affordable Healthcare Choices Act (the Act) was released. The Act was created by Senator Edward Kennedy and the Senate Committee on Health, Education, Labor and Pensions [1]. The five major elements of the Act are as follows:
Choice: An important foundation of the Act is the principle that if you are content with the coverage you currently have, you keep it. If you don't have health insurance or don't like the insurance you currently have, the Act will give you new, more affordable options.
Cost Reduction: The Act aims to reduce current healthcare costs through stronger prevention, better quality of care and the use of information technology. It will also attempt to root out fraud and abuse, and reduce unnecessary procedures.
Prevention: The best way to treat a disease is to prevent it from ever striking, which is exactly why the Act will give citizens the information they need to take charge of their own health. The bill will make information widely available in medical settings such as schools and communities. It will also promote early screening for heart disease, cancer and depression, while providing citizens with more information on healthy nutrition and the dangers of smoking.
Health System Modernization: The Act will take strong steps to see that America has a 21st-century workforce for a modern and responsive healthcare system. It emphasizes sound investments in training the doctors, nurses, and other health professionals who will serve the needs of patients in future years.
Long Term Care and Services: The Act will also help make it possible for the elderly and disabled to live at home and function independently. It would assist them in having wheelchair accessible ramps installed in their homes, hiring a care worker to check in on them regularly, and provide an array of other support fucntions to enable them to stay in their communities instead of moving to nursing homes [2].
At this point in time the Act is only a preliminary draft, and will almost assuredly undergo significant changes before it heads to Congress. The main concern expressed over the Act revolves around how to pay for the proposed system overhaul. Early estimates by the Congressional Budget Office (CBO) priced the plan at approximately $1.6 trillion over 10 years, while only covering a third of Americans currently without healthcare [3]. The CBO estimate is a major concern to both Democrats and Republicans, considering there has been no clear cut method identified on how the overhaul will be financed.
Recently, Senate Finance Committee Chairman Max Baucus suggested a cost cutting plan for the current Medicare program as one potential method; but there are concerns among the public and CBO regarding the Baucus proposal [3]. The public concern centers around the impact that Medicare cuts would impose on their current costs; the CBO is concerned that these proposed cuts would not take place, as Congress has been very hesitant to cut Medicare benefits in the past [3].
Another method was recently implied by President Barack Obama in his announcement of a pact with industry manufactures that would result in approximately $80 billion in savings for Medicare Part D prescriptions, as well as contributions to the health plan overhaul. The only concern is the fact that there was no specific amount attributed to the system overhaul [4]. While these are only two possible methods of paying for the proposal, they illustrate the point that any system overhaul is going to result in significant changes, and costs, to a variety of individuals, from the individual taxpayer all the way to industry manufacturers. With the House set to release its proposal in the very near future, you can expect to hear more about the Affordable Healthcare Choices Act.
Sources:
[1] http://www.opencongress.org/articles/view/1033-Affordable-Health-Choices-Act
[2] http://www.simplifymd.com/wp-content/uploads/2009/06/2009_06_09.pdf
[3] http://online.wsj.com/article/SB124537120871529803.html
[4] http://online.wsj.com/article/SB124567211118336815.html
scotthoffman@cis-partners.com
On June 9, 2009 a draft copy of the Affordable Healthcare Choices Act (the Act) was released. The Act was created by Senator Edward Kennedy and the Senate Committee on Health, Education, Labor and Pensions [1]. The five major elements of the Act are as follows:
Choice: An important foundation of the Act is the principle that if you are content with the coverage you currently have, you keep it. If you don't have health insurance or don't like the insurance you currently have, the Act will give you new, more affordable options.
Cost Reduction: The Act aims to reduce current healthcare costs through stronger prevention, better quality of care and the use of information technology. It will also attempt to root out fraud and abuse, and reduce unnecessary procedures.
Prevention: The best way to treat a disease is to prevent it from ever striking, which is exactly why the Act will give citizens the information they need to take charge of their own health. The bill will make information widely available in medical settings such as schools and communities. It will also promote early screening for heart disease, cancer and depression, while providing citizens with more information on healthy nutrition and the dangers of smoking.
Health System Modernization: The Act will take strong steps to see that America has a 21st-century workforce for a modern and responsive healthcare system. It emphasizes sound investments in training the doctors, nurses, and other health professionals who will serve the needs of patients in future years.
Long Term Care and Services: The Act will also help make it possible for the elderly and disabled to live at home and function independently. It would assist them in having wheelchair accessible ramps installed in their homes, hiring a care worker to check in on them regularly, and provide an array of other support fucntions to enable them to stay in their communities instead of moving to nursing homes [2].
At this point in time the Act is only a preliminary draft, and will almost assuredly undergo significant changes before it heads to Congress. The main concern expressed over the Act revolves around how to pay for the proposed system overhaul. Early estimates by the Congressional Budget Office (CBO) priced the plan at approximately $1.6 trillion over 10 years, while only covering a third of Americans currently without healthcare [3]. The CBO estimate is a major concern to both Democrats and Republicans, considering there has been no clear cut method identified on how the overhaul will be financed.
Recently, Senate Finance Committee Chairman Max Baucus suggested a cost cutting plan for the current Medicare program as one potential method; but there are concerns among the public and CBO regarding the Baucus proposal [3]. The public concern centers around the impact that Medicare cuts would impose on their current costs; the CBO is concerned that these proposed cuts would not take place, as Congress has been very hesitant to cut Medicare benefits in the past [3].
Another method was recently implied by President Barack Obama in his announcement of a pact with industry manufactures that would result in approximately $80 billion in savings for Medicare Part D prescriptions, as well as contributions to the health plan overhaul. The only concern is the fact that there was no specific amount attributed to the system overhaul [4]. While these are only two possible methods of paying for the proposal, they illustrate the point that any system overhaul is going to result in significant changes, and costs, to a variety of individuals, from the individual taxpayer all the way to industry manufacturers. With the House set to release its proposal in the very near future, you can expect to hear more about the Affordable Healthcare Choices Act.
Sources:
[1] http://www.opencongress.org/articles/view/1033-Affordable-Health-Choices-Act
[2] http://www.simplifymd.com/wp-content/uploads/2009/06/2009_06_09.pdf
[3] http://online.wsj.com/article/SB124537120871529803.html
[4] http://online.wsj.com/article/SB124567211118336815.html
Friday, July 17, 2009
A Blog about a Blog
By: Karen Brown, Senior Director of Marketing
karenbrown@cis-partners.com
Thumbs up to the FDA for stepping into the 21st century social media realm for their efforts in launching the FDA Transparency Blog on June 2nd. (Apologies to those outside the U.S., where the thumbs up gesture is considered foul and pejorative.)
According to the new blog, the Administration is committed to eliminating barriers between the American people and their government.
The blog encourages readers to submit ideas and suggestions on how to improve transparency at the agency. In addition, you can submit electronic comments to the Federal Register, and, the public is encouraged to attend a meeting later this month with members of the Task Force.
So far, the blog has been met with some skepticism, receiving comments questioning the FDA’s visibility objectives: “Transparency to the American public is a fine goal and I applaud your efforts to do this in an online forum. However, the industries you regulate need the FDA to be transparent as well.”
I’d recommend giving this a little more time before we assume the thumbs down position. This could be the opportunity that the pharmaceutical industry needs to set up similar online discussions. Today, there are only a few large pharmaceutical manufacturers who regularly maintain a blog, though the number of companies using Twitter at a corporate level has grown to about 12.
You can check out the FDA’s blog at: http://fdatransparencyblog.fda.gov/2009/06/transparency-blog.html
Other Sources:
http://www.doseofdigital.com/healthcare-pharma-social-media-wiki/
GSK US Twitter
karenbrown@cis-partners.com
Thumbs up to the FDA for stepping into the 21st century social media realm for their efforts in launching the FDA Transparency Blog on June 2nd. (Apologies to those outside the U.S., where the thumbs up gesture is considered foul and pejorative.)
According to the new blog, the Administration is committed to eliminating barriers between the American people and their government.
The blog encourages readers to submit ideas and suggestions on how to improve transparency at the agency. In addition, you can submit electronic comments to the Federal Register, and, the public is encouraged to attend a meeting later this month with members of the Task Force.
So far, the blog has been met with some skepticism, receiving comments questioning the FDA’s visibility objectives: “Transparency to the American public is a fine goal and I applaud your efforts to do this in an online forum. However, the industries you regulate need the FDA to be transparent as well.”
I’d recommend giving this a little more time before we assume the thumbs down position. This could be the opportunity that the pharmaceutical industry needs to set up similar online discussions. Today, there are only a few large pharmaceutical manufacturers who regularly maintain a blog, though the number of companies using Twitter at a corporate level has grown to about 12.
You can check out the FDA’s blog at: http://fdatransparencyblog.fda.gov/2009/06/transparency-blog.html
Other Sources:
http://www.doseofdigital.com/healthcare-pharma-social-media-wiki/
GSK US Twitter
Thursday, July 16, 2009
The Quality by Design Initiative
By: Gary Miller, CIS Senior Compliance Associate
garymiller@cis-partners.com
In 2005, the Food and Drug Administration (FDA) started a pilot program to allow participating companies to submit chemistry manufacturing and controls (CMC) information demonstrating the application of Quality by Design (QbD). The drug applications to be reviewed during this pilot program are meant to provide examples of how design, space and process knowledge can be captured at an operational level, and how they can relate to normal operating ranges, equipment, and scale. [1] QbD is fundamentally built upon the theory of continuous process, which has been used in chemical manufacturing for quite some time now.
The Center for Drug Evaluation and Research (CDER) Office of New Drug Quality Assessment has stated that “the pharmaceutical industry can only realize the full benefit of QbD by developing and implementing continuous process.”[2] The FDA has a view of QbD as a “systematic approach to product and process design and development.”[3] Lawrence Yu, PhD, director for Science Office of Generic Drugs for the FDA, defines QbD as “designing and developing formulations and manufacturing processes to ensure predefined product quality. This involves the understanding of controlling formulation and manufacturing process variables affecting the quality of a drug.”[4]
In an attempt to reach this necessary understanding, the FDA has granted the National Institute of Pharmaceutical Technology and Education a $1.19 million contract. The FDA has said that “The intention of this award is the development of specifications allowing for the implementation of Quality by Design (QbD) framework to improve product quality through science and technology.”[4] The ultimate goal of this research, along with all principles of QbD, is to improve end product quality. The research is scheduled to end in September of 2010, and “the results of the study will potentially serve as the basis for formulating best practices and developing science based guidance documents that can be used by the FDA to evaluate new and generic drug applications.”[4]
Some of the key elements of QbD have already been identified. Chi-wan Chen, Deputy Director of the Office of New Drug Quality Assessment at the CDER, outlined some of the features of QbD that have already been identified in subsequent studies. The elements include:
So where does the implementation stand today? Big Pharma has been able to pursue this avenue with effectiveness, but many mid-tier Pharma companies have fallen back on old habits. It is believed in the industry that the FDA must continue to apply more pressure on the companies to change, or they will not see a need to expel the resources needed to make significant changes. Success also relies on the industry and the FDA moving toward a cohesive methodology, and sending a message explaining the need for these changes. Designing a QbD solution that is both pragmatic from a compliance standpoint, and flexible from a business perspective, will keep the pressure on industry to truly embrace the principles of QbD. [6]
Sources:
1. FDA Promotes QbD for Biotech Therapies - By Jill Wechsler, October 1, 2008
http://biopharminternational.findpharma.com/biopharm/Quality/FDA-Promotes-QbD-for-Biotech-Therapies/ArticleStandard/Article/detail/557244
2. “Quality by Design (QbD): Myth or Reality” - By Girish Malhotra, PE, President EPCOT International
http://www.pharmpro.com/ShowPR.aspx?PUBCODE=021&ACCT=0000100&ISSUE=0702&RELTYPE=PR&ORIGRELTYPE=ATO&PRODCODE=0000&PRODLETT=N&CommonCount=0
3. FDA Perspective on Quality by Design - By Patricia Van Arnum, Dec. 5 2007
http://pharmtech.findpharma.com/pharmtech/Article/A-FDA-Perspective-on-Quality-by-Design/ArticleStandard/Article/detail/469915
4. Implementation of Quality-by-Design: OGD Initiatives - By Lawrence Yu, PhD, Director for Science Office of Generic Drugs, FDA
http://www.fda.gov/ohrms/dockets/AC/06/slides/2006-4241s1_8.ppt
3. FDA Awards NIPTE $1.19 Million Contract to Develop Quality by Design (QbD) Guidance Elements - October 29, 2008
http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20081029005227&newsLang=en
6. QbD: An Interim Report Card - By Bikash Chatterjee, Pharmtech Associates, Inc.
http://www.pharmamanufacturing.com/articles/2007/158.html
garymiller@cis-partners.com
In 2005, the Food and Drug Administration (FDA) started a pilot program to allow participating companies to submit chemistry manufacturing and controls (CMC) information demonstrating the application of Quality by Design (QbD). The drug applications to be reviewed during this pilot program are meant to provide examples of how design, space and process knowledge can be captured at an operational level, and how they can relate to normal operating ranges, equipment, and scale. [1] QbD is fundamentally built upon the theory of continuous process, which has been used in chemical manufacturing for quite some time now.
The Center for Drug Evaluation and Research (CDER) Office of New Drug Quality Assessment has stated that “the pharmaceutical industry can only realize the full benefit of QbD by developing and implementing continuous process.”[2] The FDA has a view of QbD as a “systematic approach to product and process design and development.”[3] Lawrence Yu, PhD, director for Science Office of Generic Drugs for the FDA, defines QbD as “designing and developing formulations and manufacturing processes to ensure predefined product quality. This involves the understanding of controlling formulation and manufacturing process variables affecting the quality of a drug.”[4]
In an attempt to reach this necessary understanding, the FDA has granted the National Institute of Pharmaceutical Technology and Education a $1.19 million contract. The FDA has said that “The intention of this award is the development of specifications allowing for the implementation of Quality by Design (QbD) framework to improve product quality through science and technology.”[4] The ultimate goal of this research, along with all principles of QbD, is to improve end product quality. The research is scheduled to end in September of 2010, and “the results of the study will potentially serve as the basis for formulating best practices and developing science based guidance documents that can be used by the FDA to evaluate new and generic drug applications.”[4]
Some of the key elements of QbD have already been identified. Chi-wan Chen, Deputy Director of the Office of New Drug Quality Assessment at the CDER, outlined some of the features of QbD that have already been identified in subsequent studies. The elements include:
- Targeting the product profile
- Determining the Critical Quality Attributes (CQAs)
- Linking raw material attributes and process parameters to CQAs and perform risk assessment
- Developing a design space
- Designing and implementing a control strategy
- Managing product life cycle, including continual improvements [3]
So where does the implementation stand today? Big Pharma has been able to pursue this avenue with effectiveness, but many mid-tier Pharma companies have fallen back on old habits. It is believed in the industry that the FDA must continue to apply more pressure on the companies to change, or they will not see a need to expel the resources needed to make significant changes. Success also relies on the industry and the FDA moving toward a cohesive methodology, and sending a message explaining the need for these changes. Designing a QbD solution that is both pragmatic from a compliance standpoint, and flexible from a business perspective, will keep the pressure on industry to truly embrace the principles of QbD. [6]
Sources:
1. FDA Promotes QbD for Biotech Therapies - By Jill Wechsler, October 1, 2008
http://biopharminternational.findpharma.com/biopharm/Quality/FDA-Promotes-QbD-for-Biotech-Therapies/ArticleStandard/Article/detail/557244
2. “Quality by Design (QbD): Myth or Reality” - By Girish Malhotra, PE, President EPCOT International
http://www.pharmpro.com/ShowPR.aspx?PUBCODE=021&ACCT=0000100&ISSUE=0702&RELTYPE=PR&ORIGRELTYPE=ATO&PRODCODE=0000&PRODLETT=N&CommonCount=0
3. FDA Perspective on Quality by Design - By Patricia Van Arnum, Dec. 5 2007
http://pharmtech.findpharma.com/pharmtech/Article/A-FDA-Perspective-on-Quality-by-Design/ArticleStandard/Article/detail/469915
4. Implementation of Quality-by-Design: OGD Initiatives - By Lawrence Yu, PhD, Director for Science Office of Generic Drugs, FDA
http://www.fda.gov/ohrms/dockets/AC/06/slides/2006-4241s1_8.ppt
3. FDA Awards NIPTE $1.19 Million Contract to Develop Quality by Design (QbD) Guidance Elements - October 29, 2008
http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20081029005227&newsLang=en
6. QbD: An Interim Report Card - By Bikash Chatterjee, Pharmtech Associates, Inc.
http://www.pharmamanufacturing.com/articles/2007/158.html
Wednesday, July 15, 2009
Congress Considers Taxing Prescription Drug Advertising
By: Amy Lotman, CIS Senior Compliance Manager
amylotman@cis-partners.com
The advertising, broadcast and medical publishing sectors were thrown into a tizzy on June 16, when reports from Capitol Hill said that removing the tax deductibility of drug promotional expenses remains a live issue in the funding discussions around health care reform.
There have been reverberations for over a year that pharma’s critics on Capitol Hill might try to raise some money for health care reform by tapping into the drug industry’s marketing budgets. White House Chief of Staff Rahm Emanuel has previously talked about giving manufacturers a choice between deducting R&D expenses or promotional expenses.
Rep. Charles Rangel (D-NY), the very powerful Chairman of the House Ways & Means Committee, recently made some public comments about abolishing the deduction. Chairman Rangel told reporters that House tax writers are considering a $37 billion proposal that would prohibit companies from taking deductions on advertising for prescription drugs, saying that the tendency to "mumble" about side effects is "wrong."
The $37 billion price tag that Rangel casually attached to the possible change quantified the challenge and gave it a magnitude that made it more threatening.
While Rep. Rangel admitted that the pharmaceutical advertising provision would only pay for a tiny piece of a bill that is expected to cost $1.2 trillion over 10 years, he emphasized that a number of new tax provisions may be needed to ensure the bill’s effectiveness.
Advertising, media and marketing groups are intensifying grassroots efforts to defeat such a proposal.
Sources:
http://rangel.house.gov/
http://www.bloomberg.com/apps/news?pid=20601103&sid=aeEJZicjYE60
amylotman@cis-partners.com
The advertising, broadcast and medical publishing sectors were thrown into a tizzy on June 16, when reports from Capitol Hill said that removing the tax deductibility of drug promotional expenses remains a live issue in the funding discussions around health care reform.
There have been reverberations for over a year that pharma’s critics on Capitol Hill might try to raise some money for health care reform by tapping into the drug industry’s marketing budgets. White House Chief of Staff Rahm Emanuel has previously talked about giving manufacturers a choice between deducting R&D expenses or promotional expenses.
Rep. Charles Rangel (D-NY), the very powerful Chairman of the House Ways & Means Committee, recently made some public comments about abolishing the deduction. Chairman Rangel told reporters that House tax writers are considering a $37 billion proposal that would prohibit companies from taking deductions on advertising for prescription drugs, saying that the tendency to "mumble" about side effects is "wrong."
The $37 billion price tag that Rangel casually attached to the possible change quantified the challenge and gave it a magnitude that made it more threatening.
While Rep. Rangel admitted that the pharmaceutical advertising provision would only pay for a tiny piece of a bill that is expected to cost $1.2 trillion over 10 years, he emphasized that a number of new tax provisions may be needed to ensure the bill’s effectiveness.
Advertising, media and marketing groups are intensifying grassroots efforts to defeat such a proposal.
Sources:
http://rangel.house.gov/
http://www.bloomberg.com/apps/news?pid=20601103&sid=aeEJZicjYE60
Tuesday, July 14, 2009
Faster, Better, Stronger: Speeding up Medical Imagery
By: Craig Kubicek, CIS Compliance Associate
craigkubicek@cis-partners.com
It is absolutely amazing to think about what computers can do nowadays. They allow us to stay in contact with others, check our bank accounts, read the news, follow our favorite teams, etcetera, etcetera.
Our lives have become so easy as we sit down in front of our computers to perform our jobs. However, I am not here to make you read about how personal computing has shaped our lives. I would like to touch on a topic that not many of us stop to think about, or for that matter, care about: Computing for Researchers.
Computers have become such a staple of our lives that even researchers rely on them. However, researchers are power hungry and require many computers linked up to provide them enough processing power to perform their biological researched functions and mathematical calculations. Fortunately, a corporation named Nvidia has created a huge breakthrough in the realm of supercomputers.
Nvidia’s specialty is Graphical Processing Units (GPU’s). Just recently, Nvidia produced the Tesla, which brings supercomputing to the level of personal computing. A supercomputer can now sit on a desk, instead of taking up a whole room. The concept is quite simple. The Tesla GPU is used inside a computer to reduce the amount of calculations and graphics processing that the Central Processing Unit (CPU) must perform. By taking away this heavy load of instructions, the CPU is given some room to breathe. Actually, lots of room to breathe.
What does this mean for the world? It means that the possibilities are becoming endless. Researchers can “simulate the delivery of novel nanoparticle chemotherapy drug to cancerous tissue. Simulation allows scientists to predict experimental outcomes and thus reduce the cost of development and time to clinical relevance.” [i] Boston Scientific, a worldwide producer of medical devices, also needs to simulate its products for results. With the use of Nvidia’s Tesla GPU it was able to process its simulations 25 times faster.[ii] It is not all about simulating things faster, “these advances also foster the development of new algorithms for simulating biomedical processes inside the body.” The ability to have a computer perform operations faster means that analyzing protein syntheses and chemical structures can occur quicker.
The more companies like Nvidia that can cut down on computational time, the better. "Time on a supercomputer can be extremely difficult to get, especially since some of our computations run for weeks to months. Also, buying a supercomputer is expensive for every university research group," said Axel Kohlmeyer, associate director at the Center for Molecular Modeling at the University of Pennsylvania. Kohlmeyer and the research team were able run their “molecular dynamics algorithms up to 100X faster and more importantly run bigger and more complex simulations and do research that was impossible to do before.”[iii] Of course, only with the help of Nvidia’s Tesla GPU.
No, I am not, nor have I ever been a Nvidia salesman, but I must confess that new innovations in technology have always thrilled me. It is exciting to think that clinical trials, medical procedures, cancer research simulations and much more can be sped up with only a desktop computer. Here’s to the future.
[i] http://www.accelereyes.com/success_story/drug_delivery_model.php
[ii] http://www.nvidia.com/object/acceleware_boston_scientific.html
[iii] http://www.reuters.com/article/pressRelease/idUS106675+04-May-2009+PRN20090504
craigkubicek@cis-partners.com
It is absolutely amazing to think about what computers can do nowadays. They allow us to stay in contact with others, check our bank accounts, read the news, follow our favorite teams, etcetera, etcetera.
Our lives have become so easy as we sit down in front of our computers to perform our jobs. However, I am not here to make you read about how personal computing has shaped our lives. I would like to touch on a topic that not many of us stop to think about, or for that matter, care about: Computing for Researchers.
Computers have become such a staple of our lives that even researchers rely on them. However, researchers are power hungry and require many computers linked up to provide them enough processing power to perform their biological researched functions and mathematical calculations. Fortunately, a corporation named Nvidia has created a huge breakthrough in the realm of supercomputers.
Nvidia’s specialty is Graphical Processing Units (GPU’s). Just recently, Nvidia produced the Tesla, which brings supercomputing to the level of personal computing. A supercomputer can now sit on a desk, instead of taking up a whole room. The concept is quite simple. The Tesla GPU is used inside a computer to reduce the amount of calculations and graphics processing that the Central Processing Unit (CPU) must perform. By taking away this heavy load of instructions, the CPU is given some room to breathe. Actually, lots of room to breathe.
What does this mean for the world? It means that the possibilities are becoming endless. Researchers can “simulate the delivery of novel nanoparticle chemotherapy drug to cancerous tissue. Simulation allows scientists to predict experimental outcomes and thus reduce the cost of development and time to clinical relevance.” [i] Boston Scientific, a worldwide producer of medical devices, also needs to simulate its products for results. With the use of Nvidia’s Tesla GPU it was able to process its simulations 25 times faster.[ii] It is not all about simulating things faster, “these advances also foster the development of new algorithms for simulating biomedical processes inside the body.” The ability to have a computer perform operations faster means that analyzing protein syntheses and chemical structures can occur quicker.
The more companies like Nvidia that can cut down on computational time, the better. "Time on a supercomputer can be extremely difficult to get, especially since some of our computations run for weeks to months. Also, buying a supercomputer is expensive for every university research group," said Axel Kohlmeyer, associate director at the Center for Molecular Modeling at the University of Pennsylvania. Kohlmeyer and the research team were able run their “molecular dynamics algorithms up to 100X faster and more importantly run bigger and more complex simulations and do research that was impossible to do before.”[iii] Of course, only with the help of Nvidia’s Tesla GPU.
No, I am not, nor have I ever been a Nvidia salesman, but I must confess that new innovations in technology have always thrilled me. It is exciting to think that clinical trials, medical procedures, cancer research simulations and much more can be sped up with only a desktop computer. Here’s to the future.
[i] http://www.accelereyes.com/success_story/drug_delivery_model.php
[ii] http://www.nvidia.com/object/acceleware_boston_scientific.html
[iii] http://www.reuters.com/article/pressRelease/idUS106675+04-May-2009+PRN20090504
Monday, July 13, 2009
CIS Recognizes Steven Moore
Dear Blog Readers,
On Friday, CIS founders Jim Collins and Toni Barsh awarded the 2009 President's Award to Business Development Director Steven Moore. Those of you who have been following along for a while have undoubtedly read Steve's tales of the road, have enjoyed stories from numerous conferences, and have learned about some of his favorite (and least favorite) things. But what you have not read about is Steve's tireless dedication to CIS, his clients, and his colleagues.
Steve (almost) always has a smile on his face, and time to lend a hand to a fellow employee. In his time with CIS he has grown both personally and professionally and, in the opinion of those around him, he continues to do so. Having worked with him for the past year, I can attest that he is an excellent mentor, as well as a great example of the power of hard work and enthusiasm.
Congratulations Steve, and thank you for all that you do "For Our Space."
*
On Friday, CIS founders Jim Collins and Toni Barsh awarded the 2009 President's Award to Business Development Director Steven Moore. Those of you who have been following along for a while have undoubtedly read Steve's tales of the road, have enjoyed stories from numerous conferences, and have learned about some of his favorite (and least favorite) things. But what you have not read about is Steve's tireless dedication to CIS, his clients, and his colleagues.
Steve (almost) always has a smile on his face, and time to lend a hand to a fellow employee. In his time with CIS he has grown both personally and professionally and, in the opinion of those around him, he continues to do so. Having worked with him for the past year, I can attest that he is an excellent mentor, as well as a great example of the power of hard work and enthusiasm.
Congratulations Steve, and thank you for all that you do "For Our Space."
*
Thursday, July 9, 2009
The PCB Celebrates 500 Posts!
Dear PCB Readers,
This week we are proud to announce a milestone, our blog has reached 500 posts! There are many people to thank for the success of the Pharma Compliance Blog: Steven Moore, the mastermind behind the blog, and a frequent and popular contributer; C
This week we are proud to announce a milestone, our blog has reached 500 posts! There are many people to thank for the success of the Pharma Compliance Blog: Steven Moore, the mastermind behind the blog, and a frequent and popular contributer; C