CVS Looks to Generation Health to Head Caremark

By: Kerri McCutchin, CIS Compliance Associate
kerrimccutchin@cis-partners.com

On December 21, 2009, CVS Caremark Corporation announced the appointment of Per G.H. Lofberg as president of its pharmacy benefit management business (PBM), effective January 4, 2010. Lofberg has more than 30 years experience in the healthcare and PBM industry, “including the role of Chairmen for Merck Medco Managed Care LLC, which later became Medco Health Solutions.”(1) Lofberg is currently serving in the roles of President and CEO of Generation Health Inc., a company that focuses on genetic testing benefit management. By hiring Lofberg, Generation Health has become a strategic partner with CVS Caremark; this collaboration has resulted in the expansion of pharmacogenomic (which is the interaction between medications and a patient's genes) clinical and testing services for customers [1].

One of the services that CVS will offer is counseling patients with certain diseases to undergo genetic tests. Among the first patients to receive counseling are those with diseases in which genes are known to play a role in what drugs are effective in treatment. “The company said those patients will be encouraged to use a drug that has been proven to work on people with a similar genetic profile as their own.” [1]

It seems many are optimistic about the experience and knowledge Lofberg can bring to CVS Caremark Corporation. Tom Ryan, Chairman, President and CEO of CVS Caremark notes:

"Per is widely respected in the PBM and health care industry. He brings a wealth
of experience in working with key clients to understand the needs of the
marketplace and produce meaningful results. His expertise, along with his
demonstrated ability to execute growth strategies, makes him the perfect person
to guide our PBM in the evolving health care environment." [1]

One possible explanation for hiring Lofberg might be that it was an initiative taken by CVS Caremark Corporation in hopes of combining its drug benefit management services with patients' genetic profiles. In November, Generation Health Inc. and CVS Caremark Corporation established a partnership to research pharmacogenomics. In particular, pharmacogenomics can determine whether or not a drug works for specific patients [2]. The utilization of pharmacogenomics could improve treatment and reduce costs for Caremark, allowing patients to avoid drugs that would not work for them. CVS will begin to offer some pharmacogenomic services starting in the second quarter of 2010 and will focus largely on diseases such as cancer, heart disease and HIV [3].

Lofberg comments that “he is looking forward to the opportunities and challenges of running one of the nation's largest PBMs” and states, "CVS Caremark's corporate resources and its leadership position as the country's largest provider of pharmacy services offers a tremendous platform for innovation and growth in our complex and challenging health care system” [1].

Sources:
[1] http://info.cvscaremark.com/newsroom/press-releases/cvs-caremark-appoints-lofberg-president-pbm-business
[2] http://news.yahoo.com/s/ap/20091221/ap_on_bi_ge/us_cvs_caremark_generation_health_2
[3] http://www.google.com/hostednews/ap/article/ALeqM5gN_2fpJwvjczd8KMa40QOOHRLrDgD9CNVN7G0

On the Twelfth Day of CIS...

As reported to Jess Ebert, CIS Compliance Specialist

On the twelfth day of CIS, the blog introduced to me…
Founding Partner and VP of Account Management, Toni Barsh
(and Jim Collins, 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 graduated with a BA and went right into pharma working for a pharmaceutical advertising agency where I held many roles, but became an Account Manager for CME programs and promotional events. I went from one agency to another, helping clients with patient education and working with brand managers on product positioning and marketing. After following the Ad Agency route for a while, I took a job at Wyeth in the Sales and Marketing Department. I helped with the launch of Norplant and worked in company positioning (as Wyeth products expired, we would allocate surplus products to indigent countries for donations).

Ready for a change, I started a little consulting company in marketing/advertising. I then changed direction and joined a clinical training/education subsidiary of Parexel, where I spent 5 years working as the training manager and transitioning into consulting sales. Due to lack of growth, I started my second business in clinical training and process consulting. After 5 years I teamed up with Jim Collins, and the rest is CIS history!

Q: Why did you decide to start CIS?
A: I ran my second consulting company for 5 years, and was burned out being a "single shingle." [CIS Co-Founder] Jim Collins and I collaborated on a new business venture that immediately interested me. We already had a 10 year working relationship, so partnering with Jim was a no brainer. My best professional decision yet!

Q: What projects and product lines do you work with at CIS?
A: I help wherever I am needed. I work primarily in Account Management supporting our managers. I also try to get a bit of Business Development in from time to time.

Q: What do you like about CIS?
A: I love the culture we have created here and the people I work with. I want and need to learn from the people who surround me, and I think we have some of the most talented employees around….people who want to learn, want to grow and want to be challenged!

Q: What’s the best holiday gift you’ve ever gotten (or given)?
A: The best gift I've ever given was a cruise to Bermuda for my parents' 25th wedding anniversary. The best gift I've ever received was the opportunity to adopt a child and become a parent!

Email Toni any time at tonibarsh@cis-partners.com!

There are 3 days left until the New Year!

On the Eleventh Day of CIS...

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!

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!

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

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

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 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 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 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!

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

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!

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
*

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.

Eddie: "You surprised to see us, Clark?"
Clark: "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!

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:

• 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 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!

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/

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!

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):

“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.

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/

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

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:

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

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:

• 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]

Some medicines sold online:

• 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]

Currently, one of the hot topics of discussion in the pharmaceutical industry is the worldwide spread of the H1N1 influenza virus, commonly known as Swine Flu. To date, the FDA has approved two medications for the treatment of this virus: Tamiflu and Relenza. In October 2009, the FDA issued an official warning to urge consumers to be cautious when purchasing these products over the Internet. The warning came as a result of the FDA’s purchase, and subsequent analysis, of several Tamiflu products over the internet. According to the FDA, one such Tamiflu product:

“arrived in an unmarked envelope with a postmark from India and consisted of
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]

Without 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:

“Products that are offered for sale online with claims to diagnose, prevent,
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]

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.

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