The PharmaCertify™ Team

Something new and exciting was in the air this week. Or rather on the airwaves. The new TV season kicked off! Finally, after a summer of re-runs and reality shows, the new comedies and dramas (oh, okay, and more reality) are back to entertain. There will be more premiers next week, but in the meantime let us entertain you with this week’s PC News Week in Review.

Are doctors largely avoiding Law and Order when it comes to kickback cases? Avoiding may be a strong word, but despite the lawmakers’ feelings on the topic, doctors are generally not prosecuted when pharma companies are charged with violating the Anti-kickback statue. Why?  One reason cited by an article in the Washington Post was that doctors are not an attractive target for a prosecutor. Doctors face the loss of their license as well as prison time, and thus are willing to spend heavily on their defense. Other reasons include the difficulty in proving a doctor was recommending a product because of a kickback and not because he or she believes in the product, and, prosecutors simply being burned out after dealing with the pharmaceutical company side of the case.

It appears that states Attorneys General are not embracing their authority to bring cases for HIPAA violations with Glee. Since being granted the authority in the HITECH Act, only two AGs have brought cases forward. Rather than use the authority granted them under HIPAA, AGs are choosing to prosecute cases under their states’ own consumer protection and privacy laws.

It’s not Gossip, Girl (a little creative license with the punctuation). The FDA has created some drama (e.g. reorganized) and has turned DDMAC in to the Office of Prescription Drug Promotion. Like any good makeover, the OPDP has more power and authority than it did as DDMAC. The OPDP will have one division dedicated to promotion to physicians and a division dedicated to DTC advertising.

Are you a Modern Family, opting for video chat over that old school technology called the telephone? If so, rest assured that calls you make from your iPad to your doctor are HIPAA compliant. Apple announced that calls made using its FaceTime program are HIPAA compliant with the right network security set up.

Out for Revenge possibly? Two Harvard professors have authored a paper denouncing that changes be made to the FCPA as suggested by the U.S. Chamber of Commerce. The paper’s authors believe changes would undermine the anti-corruption progress that has been made. In particular, the pair call out the compliance program defense and the Chamber’s assertion that a company shouldn’t be held liable for the corrupt activity of a subsidiary.

And if that last story didn’t have the anti-corruption X-Factor you were looking for, check out this video from Main Justice. Main Justice sits down with former head of the SFO’s Business Fraud Group to discuss enforcement of the Bribery Act.

The president of a French pharmaceutical firm may find himself Up All Night for a while as he was placed under investigation this week as part of a probe surrounding an anti-diabetic drug produced by the company. The president and founder of Servier Labortories is under investigation on suspicion of dishonest practices, deception related to the drug’s safety, and falsely obtaining authorization to sell the drug. The drug was largely prescribed as weight loss drug, and its use is being linked to the deaths of 500 people in France.

While we are certainly happy for the new fall shows, we’d be remiss if we didn’t remark on the sad ending of a show that has been around for 41 years. Today marks the last episode of ABC’s daytime soap opera, All My Children. Good-bye Erica Kane and Pine Valley!  It was a great run, and you’ll be missed…evil twins and all.

That brings us to the end of our broadcasting day. Before we sign off, we have a question: what are you doing to renew your compliance training this fall? Do you have a “time slot” to fill with a new topic or maybe there just needs to be a shake up in your current line up. Either way PharmaCertify can help with our selection of off-the-shelf and custom eLearning modules on topics ranging from Aseptic Technique to the PDMA and Sample Management.

We’ll see you right back here next week. Same bat-time, same bat-channel. Have a great weekend!