Compliance News in Review, October 14, 2016

Ghouls, goblins and ghosts galore…the haunting season is here! Enjoy it while you can, before you know it, reindeer, snowmen, and gingerbread men will be scattered across the landscapes. (Poor Thanksgiving…it gets no respect!) No tricks from us though, just treats. And by treats we mean delicious bites of news! So before you head out to wait for the Great Pumpkin, join us for this not-so-scary edition of the Compliance News in Review.

The FDA has carved out time for a public hearing on November 9th and 10th to discuss the subject of communicating off-label uses of drugs and devices. The agency hopes to hear from a variety of stakeholders, including industry representatives, healthcare professionals, patients, and research institutions. Approximately 30 topics will be discussed, ranging from the effect that increased communications will have on patient enrollment in clinical trials to how patients should be made aware that they are receiving information about an off-label use.

GSK is feeling a bit of a chill in the air. The company reached an agreement with the SEC to pay $20 million to resolve FCPA-related charges its Chinese subsidiary paid bribes to increase sales. As part of the settlement, GSK is also required to provide the SEC with reports regarding its implementation of anticorruption measures for the next two years.

Dermatologists are receiving lots of treats from the industry. A study of 2014 Open Payments data reveals that nearly three-quarters of the country’s dermatologists received payments in 2014. Most were under $50.00, but a few of the doctors received payments totaling more than $90,000.00. The study appears in JAMA Dermatology.

These are frightful times at Mylan as the company agrees to pay $465 million to settle claims it overcharged Medicaid for EpiPen. The company has come under intense fire for its pricing practices related to the product. In agreeing to the settlement, Mylan did not admit to wrongdoing.

The news of the FDA’s public hearing on communication related to the unapproved uses of drugs and devices is encouraging. Hopefully, after the forum, the agency will move quickly on the release of new guidance. As court decisions are discussed in the media and more public hearings are announced, now is a great time to reinforce appropriate promotional communication through the release of updated training.

With that, we close our autumnal edition of the Compliance News in Review. One final note – if you’re attending the Pharmaceutical and Medical Device Compliance Congress next week, stop by Booth 404 in the exhibit hall and say “boo!”

Thanks for reading and stay compliant!

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