Off-Label Promotion


Off-Label Promotion vs. Freedom of speech

First there was Amarin.  In this case Amarin wanted to make truthful non-misleading statements to doctors concerning the drug Vacepa’s off-label use.  However, the FDA threatened to bring charges of misbranding against the company and its employees.  Thus Amarin filed a civil complaint against the FDA claiming that FDA’s threat of prosecution for misbranding Vascepa had a chilling effect on Amarin’s commercial speech that was otherwise protected by the First Amendment.

On August 7, Judge Engelmayer granted a motion for preliminary injunction in favor of Amarin stating that the proposed communications concerning Vacepa are truthful and non-misleading and may not form the basis for prosecution for misbranding.

In the news this week is Pacira Pharmaceuticals who have sued the FDA stating that their off-label information is truthful and should also be allowed under the recent Amarin ruling.  As noted by FDANEWS Pacira’s lawsuit citing Amarin will likely be followed by others, weakening the FDA’s enforcement arm against drugmakers that promote products for off-label uses.

It will be very interesting to watch how these cases will play out.  As Judge Engelmayer (p.53) stated, if the speech at issue is found truthful and non-misleading, under Caronia, it may not serve as the basis for a misbranding action.  With a second case underway, how many more will follow?  will there be relief for previous cases for example the the Court of Appeals vacated a pharmaceutical sales rep’s conviction  for off-label use. Amarin (and Caronia) both differentiate between the truthful/ non-misleading speech that is protected, and the non-truthful/ misleading speech which is not protected and may still be the basis for a misbranding action.

UPDATE – As reported by FDA News (Oct 27), FDA has removed the September 2014 warning letter issued to Pacira Pharmaceuticals. In Pacira Pharmaceuticals Inc., et. al v. Food and Drug Administration et. al, the company maintains that the promotional material is truthful and should be allowed under the same ruling as Amarin Pharma Inc., et. al v. Food and Drug Administration et. al.