Courts Goes Against FDA to Allow Off-Label Promotion… Again!
[Posted on: Monday, August 17, 2015]

Off-label promotion is an enigma; it is legal if the doctors do it or if the patients do it by drawing interpretations based on their experience or reading journal articles but it is illegal if a drug company talks about the same information. More than one in five prescriptions (21%) written in the US are for off-label purposes. For some drugs such as antidepressants and pain medication, more than 90% of prescriptions written for pediatric and adolescent populations are for off-label purposes. At the same time, FDA has successfully litigated against companies for making off-label promotional claims leading to files as high as to a billion dollars and one and a half billion dollars. The basis for legality or not of off-label promotion hinges on intent; using information for commercial benefit is illegal but all else is not. According to FDA’s interpretation of the law, it is illegal even if the off-label information being discussed by a company is true and non-misleading. Twice, in the last three years, US courts have decided otherwise. In Dec 2012, the US Court of Appeal for the Second Circuit decided that off-label promotion is protected by free-speech so long as it is true and non-misleading. On Friday, 7 Aug 2015, the US District Court of the Southern District of New York ordered FDA to allow the pharmaceutical company, Amarin, to promote its omega-3 fatty acid drug Vascepa for off-label uses on the basis of its First Amendment free-speech rights. The 2012 ruling was more about decriminalizing the off-label promotion where a criminal prosecution of a sales agent was deemed illegal, while the ruling last week is more about proactively allowing off-label promotion. The 71 page ruling is a great read for anyone trying to understand the debate. Together these two ruling have turned FDA’s off-label promotion rules on their head. FDA has to be more specific in its prosecution of off-label promotion based on actually safety concerns and false and misleading claims. These ruling do provide an avenue for drug companies to promote new uses of their drugs without waiting for FDA approval of the same. It may create an environment where companies may not even seek formal approval for new uses of their drugs provided they can communicate the said uses to consumers without breaking the law. One note of caution before we turn drug promotion into the “Wild West”, both the court rulings in discussions were special cases where FDA clearly over-stepped its boundaries and had to lick its wounds. One should be very careful and have a very clear regulatory justification before extrapolating these rulings to their case. We are certainly in for a lot of similar legal battles in the near future. Also, soon FDA is expected to release a new guidance clarifying its policies in the light of the two court rulings. We will keep you posted, stay tuned.

Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research