The PharmaCertify™ Team

It was hard to tell which was louder this week: the screeching of Congress members’ tires as they peeled out of D.C. for summer break, or the wails of school children across the south as many saw their summer break end and headed back to school. Yep, it’s back to school time, so sharpen your No. 2 pencils, grab a seat and focus on the “board” – it’s time for the PC News Week in Review.

Finding himself at the head of the class this week was lawyer Michael Horowitz. The President has nominated Mr. Horowitz to be the Inspector General of the Department of Justice.  Mr. Horowitz has handled a number of FCPA cases, and is currently serving as the lead attorney for Pfizer in its FCPA case. Additionally, he has provided training to government attorneys in matters related to the FCPA. Seems like a good fit for the job considering the current push in FCPA enforcement.

Drug marketing, the kid everyone loves to pick on, got whacked again as concerns were raised over the “ads” users of the free Epocrates mobile app are forced to see. With nearly half of the nation’s doctors using Epocrates, critics are concerned that the drug industry-sponsored “Doc Alerts” will influence doctors to write prescriptions for expensive, less effective brand name drugs.  Doc Alerts can address a specific condition or medication, and can be targeted to physicians based on the types of drugs they look up in the app.  The founder of PharmedOut says patients are the ones who suffer the financial and health consequences of the influence of these ads.  Epocrates admits it can be difficult to balance the needs of both its pharmaceutical and physician customers, but says their first commitment is the value of the product to the physician.

Are laws needed to make sure authors of medical journal articles have “done their own work?”  Yes, say the authors of a policy paper in PLoS Medicine. The authors call the practice of ghostwriting of medical journal articles fraudulent, and say medical journals, institutions and other professional bodies have done little self-regulating to stop this practice. The authors are often not at all involved in the study, study design or analysis of data, and should not be allowed to sign their name to the study, the authors say. There is concern that such laws would allow for class action suits under the U.S. RICO Act.

Congress is considering relaxing the FDA advisory panel conflict of interest rules as part of an FDA funding bill. Current rules prohibit the FDA from having experts with industry ties on advisory panels. This has left many vacancies on these panels which provide recommendations on drug approvals, and has raised questions of whether the most qualified experts are being unfairly excluded. Citing a study which found that forty-four percent of cardiologist have no industry ties, critics say the FDA simply isn’t looking hard enough for its experts. They say the experts are out there, they just take a little more work to find. Some critics would like to see stronger rules. They believe even a past financial relationship will influence how a physician on a panel would vote.

Sounds like a fight might be brewing in the school yard as a pain drug monitoring company has its say about the qui tam suit filed by a competitor. Millennium Labs says it was part of a witch hunt by a competitor who alleged Millennium, along with several other competitors, violated the False Claims Act in their billing practices. The other suits were dismissed voluntarily. Millennium believes the suit against them was kept as a retaliatory strike over a defamation law suit Millennium filed against the relator in 2009.

This is not the only lawsuit trouble Millennium faces from competitors. Another lab company in Tennessee has filed a lawsuit alleging fraudulent billing practices and the provision of kickbacks to physicians.

Seeking assistance from higher education, Medtronic is giving Yale University a $2.5M grant to study its bone growth protein product, Infuse. The product has been at the center of a Congressional investigation into whether the side effects were downplayed in medical literature, as well as by company scientists who claimed certain side effects were due to surgical technique rather than the product.  The company will turn over all of its published and unpublished patient level clinical data as well as all adverse event reports. Yale will commission two CROs and will create a steering committee of advisors to review the data. Medtronic will have no input on the selection of either the CROs or the steering committee members, nor will Medtronic have any input over the release of data

Whether the kids in your area returned to school or not this week, the time is quickly approaching. (Hopefully the temperatures will be trickling down right along with the return to school! Man it was hot this week!) Is it time for some refresher training for your sales reps, marketing managers or other employees? Whether its refresher training, or freshen up training, PharmaCertify can help with our off-the-shelf, customizable compliance eLearning modules. We cover a wide range of topics including healthcare laws, good promotional practices and the FCPA.

Seems the bell for the weekend is about to ring, so we’ll wrap up this week’s review. Have a great weekend, a successful school year, and for those still on break, keep cool and enjoy these last few weeks.