The PharmaCertify™ Team

Ah, President’s Day; a time to celebrate our nation’s rich history of great leaders…with pomp, circumstance and of course, really good deals on furniture and new cars. As you wind down your day of patriotic reflection or bargain hunting and haggling, relax and enjoy all the compliance news you need to know, in our weekly News in Review.

We begin in Philadelphia, the city where Presidents Washington and Adams hung their tri-cornered hats, from 1790 to 1800. The U.S. Attorney for the District of Eastern Pennsylvania, Zane Memeger, says that the Caronia decision will not affect his office’s pursuit of off-label cases, for now. Memeger believes that individuals and corporations do not have the right to make false or misleading statements about drugs, and he sees no reason why he shouldn’t continue to prosecute the cases as he did before the well-publicized decision.

Over at the U.S. Supreme Court, several briefs have been filed supporting the Federal Trade Commission’s position that pay-for-delay deals are anti-competitive. A related is set to begin in late March. Representative Henry Waxman and organizations like the AMA and AARP sent briefs detailing their concern about the potential drug costs to the government and consumers. Representing several states, Washington D.C., and Puerto Rico, New York Attorney General, Eric Schniederman, sent a brief stating that the attorneys general believe any payment intended to delay a generic drug’s entry into the market constitutes an unlawful inducement.

The FDA is considering a monumental change to generic drug labeling regulations. The revised rule would allow generic drug manufacturers to change their label when the situation warrants. Current regulations dictate that generic drugs must have the same label information as the brand name product. The change would allow generic manufacturers to make label changes to add side effects that are not included on the brand label.

Now that CMS has released the final rule on Sunshine, Medical Marketing and Media has released a list of winners and losers related to the Act. The winners, including CROs, market research firms, and accredited CME providers, all benefited from the lighter level of detail required for payment tracking. The losers, including medical education providers, medical societies, and the hospitality industry, are likely to see changes in their business dealings with the industry.

When pharmaceutical company lobbyists (or in this case, sales reps) speak, medical students listen. At least that’s what two new studies about the impact of gift bans on the prescribing habits of medical students reveal. A study by the British Medical Journal followed 2,500 students who attended medical that had gift bans in place, and compared their prescribing habits to counterparts who attended schools that allowed gifts from reps. Physicians who attended the schools where gifts were banned were less likely to prescribe new and heavily marketing drugs. A similar study, conducted by Medical Care, compared the prescribing habits of doctors who completed residency before 2001 to those who completed residency in 2008, when gift bans were more common. Those in the programs that had bans in place were less likely to prescribe new, heavily marketed drugs.

And so ends another week of the pontification we call the News in Review. Have a great week everyone!