Amarin and FDA settle off-label suit

As we reported last August, U.S. District Judge Paul Engelmayer ruled that Amarin Pharma has a First Amendment right to truthfully promote its prescription drug Vascepa for off-label uses. August 10, 2015,  article.  Shortly afterward, Amarin and the government entered settlement talks.  August 31, 2015 update. We are now able to report that on March 8, 2016, the parties entered into a proposed Settlement Agreement resolving all causes of action in Amarin's suit against the FDA.

In June 2015, Amarin had sought to enjoin the FDA from prohibiting claims about Vascepa's efficacy in patients with "persistently high triglyceride levels" when its approved indications had been restricted to patients with "very high triglyceride levels." In his August 7, 2015, Opinion and Order, Judge Engelmeyer granted Amarin's motion for a preliminary injunction reasoning that under Caronia, Amarin may make truthful and non-misleading statements promoting Vascepa's potential benefits for patients with persistently high triglyceride levels without fear of prosecution. Op. & Order.

In a series of settlement activities that began in August 2015 and culminated yesterday, the parties reached a proposed agreement ending the underlying suit.

In resolving the case, FDA agreed that Amarin may promote Vascepa for patients with persistently high triglycerides notwithstanding the fact that the drug is not approved for that indication. In addition, FDA agreed that Amarin's speech was truthful and not misleading.

Going forward, the parties agreed to the following key provisions:

• Amarin bears the responsibility of assurance that its promotions to physicians regarding off-label use of Amarin remain truthful and non-misleading;
• There are no limitations on Amarin's right to submit prospective communications to FDA for comment; and no limitations on Amarin's constitutional rights to free speech concerning Vascepa;
• Between the entry of the settlement and December 31, 2020, Amarin will have the right to submit to FDA up to two new communications per calendar year concerning the off label use of Vascepa. FDA will have 60 days to voice any concerns and Amarin will have 45 days to respond. Within 30 days following Amarin's response, FDA will determine if — and to what extent, why — a dispute remains, at which time either party may file a motion with the Court requesting judicial resolution.

Amarin appears to have solidified its ability to promote Vascepa without regard to FDA's approved labeling as long as that promotion is truthful and not misleading. Together with the FDA's recent settlement with Pacira, this case  signals the dramatic impact the Second Circuit's decision in Caronia may  have on FDA's regulation of off-label promotion.