We have been closely following Amarin Pharm, Inc. v. FDA with respect to the preliminary injunction granted by the Southern District of New York that prohibited the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug Vascepa. We’ve also been following the similar Pacira Pharm., Inc. v. FDA case, which settled in December 2015. Yesterday, the parties in Amarin filed a letter advising the court that those parties also had reached a settlement, and its terms are notable in several respects.

As you may recall, Vascepa was approved by the FDA to treat adult patients with “very high” triglyceride levels, and Amarin sought to disclose truthful, non-misleading information to doctors that Vascepa could also be used to treat patients with “high” triglyceride levels. The District Court’s Opinion and Order is available at:  Amarin Pharma, Inc. v. FDA, 119 F. Supp. 3d 196 (SDNY 2015).

Since the court’s August 2015 order, the parties have been discussing settlement, and the proceedings have been stayed while they did so.

The parties’ March 8, 2016 proposed order of settlement includes the following provisions:

  • Defendants agree to be bound by the Court’s conclusion that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa and, under United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), such speech may not form the basis of a prosecution for misbranding.
  • Defendants agree to be bound by the Court’s conclusion that the combination of statements and disclosures that Amarin proposes to make to doctors relating to the use of Vascepa in patients with persistently high triglycerides, as those statements were modified in the court’s August 7, 2015 Order, are truthful and non-misleading.
  • Amarin bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading.
  • Amarin may submit to the FDA, through certain pre-clearance procedures, up to two proposed communications per calendar year about the off-label use of Vascepa before communicating them in promotion to doctors to determine if the FDA has concerns with Amarin’s proposed communications. If the FDA has any concerns, it will contact Amarin. The proposed order of settlement includes the timeline and procedure for resolving any dispute.
  • The parties also waive all rights to appeal the proposed settlement order.

The Amarin settlement is notable because the FDA now has agreed that a manufacturer can engage in truthful, non-misleading promotion about off-label uses that fall outside the scope of its scientific and medical publications Guidance, and its responding to unsolicited requests Guidance. Whether it signals that the FDA agrees that, more generally, truthful, non-misleading promotion is permissible remains to be seen, however, because the Amarin settlement comes within the context of some rather case-specific facts. Moreover, even if the Amarin settlement does reflect FDA recognition that the First Amendment protects rather more speech than it has acknowledged to date, determining whether given speech is “truthful” and “not misleading” may pose its own challenges as well.

We will update this post when the court enters an order of settlement.