Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects truthful, non-misleading promotional statements about off-label uses for approved drugs.

The case’s origins go back to the Second Circuit’s 2012 opinion in United States v. Caronia. The Court of Appeals there vacated a pharmaceutical sales representative’s conviction for conspiring to introduce a misbranded drug into interstate commerce on the ground that the First Amendment protects truthful and non-misleading speech that promotes FDA-approved drugs for off-label use. The DOJ and FDA declined to seek review either in the Second Circuit en banc or in the Supreme Court, deferring for another day the question of Caronia’s scope. That day has come.

In May 2015, Amarin proactively sought a preliminary injunction to prohibit the FDA from prosecuting the company for truthful and non-misleading statements relating to unapproved uses for its approved drug Vascepa, an omega-3 fatty acid.  In the alternative, Amarin sought declaratory relief.  In a sound opinion issued on August 7, 2015, Judge Paul A. Engelmayer granted Amarin’s application and held that statements proposed by the company were truthful and non-misleading and could not form the basis for a misbranding prosecution due to Caronia.

In the short term, the case has been stayed by Judicial Order until October 30, 2015, as the parties explore settlement. In the long term, the question whether truthful and non-misleading statements could provide the basis for a qui tam whistleblower, civil action under the False Claims Act still remains unanswered.