Jordan Lipp, Esq. | Partner, Davis Graham & Stubb
As discussed more in an earlier post, Amarin Pharma sued the FDA in May 2015 asserting that under the First Amendment’s free speech protections, it could engage in truthful and non-misleading speech promoting the off-label use of its drug, Vascepa, for the treatment of patients with persistently high triglyceride levels. On August 7, 2015, a federal judge in New York granted Amarin’s preliminary injunction in the case, and held that under the First Amendment’s free speech protections, the FDA could not bring a misbranding action against Amarin for Amarin’s off-label promotion. As the Court stated: “Where the speech at issue consists of truthful and non-misleading speech promoting the off-label use of an FDA-approved drug, such speech . . . cannot be the act upon which an action for misbranding is based.”
Yesterday, Amarin and the FDA settled this lawsuit. The settlement largely mirrors the Court’s preliminary injunction order – with the FDA agreeing “to be bound by the Court’s conclusions that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa®,” and Amarin agreeing that it “bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa® remain truthful and non-misleading.” The settlement also sets forth a preclearance procedure between Amarin and the FDA on other future off-label promotion of Vascepa.
This settlement cements Amarin’s victory on its preliminary injunction. The course of this lawsuit has provided a roadmap for drug and device manufacturers looking to promote their products off-label – in terms of how to raise such promotional plans with the courts to obtain court approval and FDA agreement on such off-label promotion.