Week in Review, Holiday Edition

With the holidays approaching, one co-pay charity falls onto the “not so nice” list, whistleblowers get the gift of protection against retaliation, and the state of Maryland finds an extra present of its own.

Well, here we are in the final stretches of the Christmas shopping season and either you’re resting peacefully, content in the knowledge that your mad dashes through mall mania are behind you, or you’re in full “take whatever is left on the shelf” panic mode. As you unwind with a cup of eggnog and a slice of recycled fruitcake, we offer a compliance-themed distraction of our own, with this edition of the News Week in Review.

Tis the season for giving, but at least one charity needs to be careful about the process. The Chronic Disease Fund (C.D.F), which provides co-pay assistance to patients with chronic conditions, has come under scrutiny for its relationship with pharmaceutical industry donors. Questions were raised in investor publications about the relationship between the charity and pharmaceutical manufacturers. C.D.F. has hired a law firm to review its practices and recommend new policies to comply with legal requirements. The organization’s president/founder has resigned.

In the spirit of the season, the U.S. Senate Judiciary Committee wants to give whistleblowers the gift of protection against retaliation. The Committee approved the Criminal Antitrust Anti-Retaliation Act of 2013 to protect whistleblowers involved in antitrust cases. The bill will allow for recourse against retaliation through a cause of action in civil court, through which compensatory damages would be possible. The bill has been sent to the House for approval.

Maryland is getting a little extra in its stocking this year since GSK has agreed to a $15 million settlement with the state over accusations the company improperly marketed three diabetes drugs. The suit was filed under Maryland’s False Health Claims Act. The company allegedly touted the drugs as being superior to competitive products, without justification, and allegedly neglected to share information about the heart disease risks associated with the drugs.

Speaking of GSK, the company announced it will no longer pay doctors to promote its drugs, and it will no longer pay for physicians to attend medical conferences. According to CEO Andrew Witty, the moves have nothing to do with the current investigation into the company’s business practices in China, but are rather an ongoing effort to “stay in step with how the world is changing.” The plans should be rolled out globally by 2016. The company also announced that starting in 2015 it will no longer compensate sales representatives based on the number of prescriptions written by doctors on a global basis. The revised compensation policy is already in place in the U.S.

The head of the Canadian Medical Association is among those caroling the approval of the move by GSK. The CMA president said it was a welcome change, and should serve as a “wake up call” for those who are too “cozy” with the industry. He said the CMA has had rules regarding relationships with industry companies for some time, and that he hopes the move by GSK will promote a larger transparency discussion in Canada.

With the final shopping hours ticking away, we won’t keep you from your appointed rounds (or from your happy dance if you happen to be in the “woo hoo I’m all done” category) any longer. We leave you with a reminder that if comprehensive compliance training on topics like on-label promotion, adverse events and the Sunshine Act are still on your own gift list, the modules and mobile apps available through the PharmaCertify™ suite of solutions offer  up-to-date and customizable content where your staff needs it most – in the field and at their fingertips.

Have a great holiday everyone!

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