On August 7, 2015, Judge Engelmayer of the Southern District of New York ruled that a pharmaceutical manufacturer's truthful and non-misleading statements about off-label drug uses are protected by the First Amendment. Amarin Pharma, Inc. v. FDA, No. 1:15-cv-03588. Amarin, the maker of the fish oil-based drug Vascepa, sought to make affirmative statements to physicians regarding the use of Vascepa for a patient population not currently approved by FDA. After unsuccessful negotiations with FDA, Amarin filed a complaint against FDA claiming that the threat of criminal prosecution chilled its commercial speech that was protected by the First Amendment. In the complaint, Amarin sought a ruling that the company may engage in truthful and non-misleading speech to doctors, both as to specific proposed statements and as a general matter, free from risk of criminal prosecution.
In addition to reviewing Amarin's specific proposed statements, the District Court also analyzed whether Amarin had a general right to make truthful and non-misleading off-label promotional statements under the First Amendment. Relying heavily on the Second Circuit's decision in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), the Court found that "[w]here the speech at issue consists of truthful and non-misleading speech promoting the off-label use of an FDA-approved drug, such speech, under Caronia, cannot be the act upon which an action for misbranding is based."
Although the Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit off-label promotion, FDA has long taken the position that a manufacturer who promotes or markets for off-label use risks criminal liability for "misbranding" under 21 USC 331(a). But this position was called into question when the Second Circuit overturned the criminal conviction of a sales representative for his truthful and non-misleading promotion of offlabel uses of a drug in the 2012 Coronia decision on First Amendment grounds. FDA declined to appeal and has argued in Amarin that Caronia was limited to the facts, namely the government's particular theory of prosecution and the jury instructions given in the underlying criminal trial, and accordingly would not impact the agency's enforcement of off-label promotion.
The District Court squarely rejected FDA's reading of Caronia, however, explaining that the Second Circuit decision was not about the specific facts at issue, but whether, consistent with the First Amendment, a misbranding prosecution can ever be based on truthful speech. And the Court found that, under Caronia, FDA may not base misbranding prosecution on speech alone without violating the First Amendment. The Court left the door open, however, to introducing evidence of speech to show the intent behind other non-speech conduct, such as company sponsored vacations for prescribing physicians.
The Court's decision could free pharmaceutical manufacturers to promote drugs more broadly so long as statements are truthful and not misleading. At the same time, companies should be mindful that the truthfulness of such off-label company statements could itself be a source of litigation. It's not yet known if FDA will appeal this decision.
An advisory providing a more in-depth analysis of the District Court's decision is available here.