The PharmaCertify™ Team

Big news coming out of 30 Rock this week. Did you hear? The Today show hyped a big announcement last week. Then Monday we found out. It was a brilliant set up. We thought for sure Mr. Lauer would take his leave of the Today show, but no. The big news: Where in the World is Matt Lauer is back for its 10th installment! Really? That’s it? Well, we here at the PC News have a “big” announcement of our own! We won’t make you wait too long either. However, a small amount of suspense is needed. It wouldn’t be a “big” announcement if there weren’t some suspense, right? As you wait on pins and needles, we give you this week’s PC News Week in Review.

We start the review with a company who is not playing games. Par Pharmaceuticals has filed an action in federal court saying FDA regulations violate the company’s first amendment rights in promoting one of its drugs. The company wishes to promote the drug for on-label uses to physicians who are prescribing the drug for off-label use. Makes sense right? Apparently, because these physicians don’t prescribe the drug on-label, the company can’t promote the drug on-label to them without violating regulations. If that doesn’t have government operation written all over it, what does?

Speaking of the FDA, it was game over for a former chemist with the agency this week, as he pled guilty to insider trading and providing false financial disclosures to the FDA. According to court documents, the chemist made profits or avoided losses totaling $3.8 million using information to which he was privy in his role at the FDA. In the plea agreement, the DOJ agreed to a prison sentence between five and seven years. However, sentencing will not occur until January. The chemist, who has agreed to pay back his illegal gains, could face additional fines.

Public companies, privately held companies; everyone gets to be “it” when it comes to FCPA enforcement. FCPA enforcement actions are up 300% over the last 10 years. While the headline making cases (Seimens for example) tend to be those involving public companies, the majority of individual charges brought since 2008 have been against employees or representatives of privately held companies.

As much fun as the FCPA is, we can’t forget about its cousin across the pond, the U.K. Bribery Act. With the Serious Fraud Office looking for a high profile case, and statements about working closely with the DOJ for potential overlap, it begs the question, is there a big anti-bribery bulls-eye on the pharma industry?

There’s no need to feel that we here in the US are the only ones on the hot seat when it comes to the scrutiny of the financial relationship between healthcare professionals and the industry. A former pharma sales rep in Australia shares all about lunches, speaking fees and marketing tactics with the press. The usual calls for disclosure and changes to codes of conduct follow.

Back here in the good ol’ USA, a professor at the Yale School of Medicine has devised a medical model that promotes the release of all clinical trial data by pharmaceutical companies. He believes this level of transparency in the industry will improve medical care by allowing physicians to completely evaluate if a drug is best for his or her patients. The professor was able to persuade Medtronic to adopt this approach, and he will be meeting with more executives from the industry in December to discuss his model.

Abbott had a couple of big announcements this week as well. Most notably, the company will split into two companies. One company will be a diversified medical products company, and will retain the Abbott name. The other company will be a research-based pharmaceutical company to be named later. In less exciting news, a financial statement showed that Abbott has reserved $1.5 billion to settle a pending off-label case.

A former Guidant sales rep is awarded $2.3 million of the $9.25 million settlement of a False Claims Act suit against the company. The suit charged the company over charged the government for pacemakers and defibrillators.

We’ll wrap this week’s new up with a client alert from Morrison and Foerster, LLP, which recommends that companies consider evaluating their current procedures and processes for physician compensation, in light of risks they may face complying with the Physician Payments Sunshine Act. The data that the law requires to be reported is the type of information typically used in pursuing violations of the Anti-kickback Statute and False Claims Act.

Well that brings us to the end of this week’s review. We hope you had a great weekend pumpkin picking, tailgating or collecting pieces for McDonald’s Monopoly game (anyone out there have Boardwalk?) What? Oh yeah, our “big” announcement…

We here at the PC News have been thinking that the name of our weekly review is, well, dull. Who better than our readers to give the weekly review a great name? So, put your creative caps on and help us give this publication a great name. If you’re attending the upcoming PCF Compliance Congress, stop by our booth with your suggestion. If you won’t be there, stay tuned for more details about how to submit your suggestion. Just think, your name could live for perpetuity on the Internet. And if that isn’t reward enough, well there just might be something else in it for you as well. Keep following us on Twitter (www.twitter.com/pharmacertify) and reading the PC News Week in Review to find out. (We HAVE to leave you with a little suspense!)