A Proposed End To 'Amarin Pharm v. FDA' Has FDA Agreeing To Abide By District Court's Order

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...