Week in Review, April 22, 2013

The PharmaCertify™ Team

I scream, you scream, we all scream for ice cream! Spring has definitely flung and the dreams of a visit to the local ice cream shop dance in our head. There’s nothing like that cold, sugary treat on an early spring day. So, while you contemplate your choice of chocolate/vanilla twist, gelato or a froyo, we’ll launch into our own little treat: this week’s News in Review.

If you thought 31 flavors was impressive, the American Medical Student Association has that beat, as they will add 400 teaching hospitals to its PharmFree Scorecard that evaluates conflict of interest policies at American Medical Schools. Going forward there will be two scorecards; one for medical school and one for teaching hospitals.

The plain old vanilla payment information posted by Pro Publica and subsequently reported by various media outlets around the country often miss the point of the purpose behind those payments, according to Policy and Medicine. A summary of several of the articles shows that while the headlines focus on the dollars, a deeper dive into the articles reveals the research and physician education behind the numbers. One physician even said he received none of the money attributed to him in the database. All of the money went to the research institute where he works. Physicians cited the importance of learning from their peers, and felt there was no conflict in being a paid speaker for products which they believed in.

The ban in India on doctors accepting gifts from pharma may be melting just a bit. The industry is concerned that the ban on doctors accepting sponsorships to medical conferences will leave doctors uninformed about the latest treatments. In response, India’s department of pharmacy is moving to legalize pharma sponsorship of medical education conferences. The proposed change to the code of ethics would allow doctors to accept economy class travel to meetings, as well as meals and registration fees for up to three international conferences per year.

The apparent freeze in enforcement of the UK Bribery Act may be about to thaw. According to a Compliance Week insider, vigorous enforcement of the Act is close at hand. Legislation that would allow American-style deferred prosecution agreements is in the final stages of adoption. The Serious Fraud Office will have the ability to resolve cases quickly, and companies may be more inclined to self-report.

The cherry on top of our sundae this week is the Pharmalot interview with OPDP chief, Tom Abrams, regarding the much ballyhooed guidance for social media drug promotion. Guess what, kids, it’s coming…someday…soonish. According to Abrams, the guidance is a top priority for the FDA. He says the agency is continually meeting with industry groups, technology companies and other stakeholders as they work on developing the guidance. Pharmalot talked to Mr. Abrams about topics like the one-click rule, limited text media for promotion, and pre-dissemination guidance. A firm date was not given for release of the guidance. However, Mr. Abrams said OPDP would make the required July 2014 deadline, and their intention was to release the guidance as soon as it was ready.

Well, that’s the scoop on this week’s News. Before we start chasing the ice cream man down the street, we have a question about your FCPA and UK Bribery Act training. With this week’s news of increased UK Bribery Act enforcement and the DOJ’s continuing interest in pursuing the pharma and med device industries for FCPA violations, anti-corruption training is more important than ever. PharmaCertify’s Understanding and Preventing Bribery in the Global Life Science Marketplace customizable eLearning module covers the details of the laws, and the unique situations that make our industry a target for enforcement agencies.

Have a great week everyone!

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