The PharmaCertify™ Team

Now is the time to shine up the good silverware, dust off that carving knife and fetch the stretchy pants from the back of closet. Thanksgiving is upon us! Bring on the food, family, friends and football. While we’re not quite ready to  start de-frosting the turkey, we are ready to give you a run down of the week that was. So pull up a chair, tie your napkin round your neck and get ready to feast on this week’s News Week in Review.

We’ll start with a little blurb, or appetizer if you prefer, of a story regarding the future of current HHS Secretary, Kathleen Sebelius. While it’s common for much of the top brass of any administration to move on at the start of a second term, there are no such whispers of a move for Ms. Sebelius. She’s expected to remain at least long enough to see the healthcare law implemented.

Like the Pilgrims, our next stories come to us from Great Britain. GSK was found guilty of three breaches of the ABPI Code. The breaches involve off-label promotion of the company’s platelet drug, Revolade and the revelations were the result of a company whistleblower. GSK was found to have breached multiple clauses, including the promotion of drugs for licensed uses (US only) and the requirement for sales reps to adhere to the ABPI Code.

GSK also agreed to a $90 million settlement with a 38 states over charges that the company illegally promoted Avandia. The states accused the company of inaccurately representing the risks associated with the drug in its marketing materials. A GSK spokesperson said the company chose to settle rather than go through expensive litigation, and the company admits no wrongdoing or liability under the states’ consumer protection laws.

Other side dishes of the week included Pfizer’s settlement of a Wyeth shareholder suit concerning misleading information about the risks associated with use of the antidepressant Pristiq. Plaintiffs claimed that Wyeth caused the price of the stock to be inflated during 2006 and 2007 by failing to release information about adverse events in a timely manner. The company also announced that the Wyeth unit will plead guilty to a misbranding misdemeanor charge as a part of its $491 million settlement with the government over the organ transplant drug, Rapamune. On the other side of the coin though, a whistleblower suit against Pfizer for its promotion of Lipitor was dismissed. A former Pfizer executive had accused the company of using a variety of illegal schemes to boost sales of drug, including kickbacks, misleading doctor education and unlawful sampling.

The main course of the week had to be the release of the long awaited guidance from the DOJ and SEC on the FCPA. If the tryptophan in the turkey doesn’t put you to sleep, you can always take a gander at the 130 page document here.

The day after the release of the document, Lanny Breuer of the DOJ and Robert Khuzmani, SEC Enforcement Division Director, held a press conference to discuss the guidance. Breuer claimed the guidance did not represent a “change in policy.” Khuzmani echoed his sentiments and said the “real value is clarity and transparency.” When asked why a more definitive line was not drawn on just who constitutes a foreign official, Mr. Khuzmani said there were many ways the control of an enterprise could be established, some of which are indirect.

You can find morel thoughts from the FCPA experts here and here, or check out this nice summary from the WSJ law blog.

Every holiday celebration has that one guest you hope doesn’t show, and in the view of one doctor, where the Sunshine Act is concerned, that “guest” is the CMS’ Center for Program Integrity (CPI). CMS has tasked the CPI with collection and dissemination of the spend reports related to the Sunshine Act. What’s the big deal? In an editorial on Amednews.com, the physician says the appointment of the CPI is troubling because it’s the anti-fraud unit of CMS. This gives the impression that any doctor appearing in the public reports will be cast as being involved in unethical behavior. He suggests that the data collection, distribution and appeals be assigned to a different division and compliance with the law be left to CPI.

The Sunshine Act is not the only morsel to come out of the ACA. Section 6004 of the ACA will also affect the industry in 2013. The section requires companies to submit a report of all their sampling activity to the FDA. The report must include: the name and quantity of drug samples requested; the name and quantity of samples distributed; the name, address, signature and professional designation of the person making or receiving the samples; and any other information requested by the Secretary of HHS. The government is likely to use the report to look for healthcare professionals who are abusing the sampling system.

No meal is complete without a really nice dessert, so in that spirit…the Massachusetts Life Sciences Center and the Massachusetts Medical Device Industry Council have teamed up to launch a mentoring program for veterans, aimed at helping returning soldiers return to civilian life. The initiative is part of AdvaMed’s Medical Technology Veterans (MVP) program, and will train 50 Massachusetts veterans for jobs in the med tech workforce. According to the organizations, a number of veterans already have the skills needed to work in the medical technology industry. The groups will hold a free, one day seminar in February.

And while we’re on the subject of the MVP program, AdvaMed announced that they will launch a website for returning veterans interested in joining the medical device industry. The site was initially offered to 25 veterans back in the summer, but now the market has been expanded to any veteran interested in a med tech job.

That’s all the tasty offerings for this week. We hope you’re geared up for a great time with family and friends on Thanksgiving. We’d like to take a moment and tell you all how thankful we are that you stop by each week and reading our little tome. We enjoy bringing it to you. Happy Thanksgiving everyone!