True and Non-misleading Off-Label Promotion is Protected Commercial Speech According to SDNY

U.S. FDA News

On August 7, 2015, Judge Engelmayer of the U.S. District Court for the Southern District of New York granted the preliminary injunction sought by Amarin Pharma against the FDA in Amarin Pharma Inc. et al v. Food and Drug Administration et al, No. 15cv3588 (S.D.N.Y. 2015). The court held that the First Amendment prevents the FDA from bringing or threatening charges of misbranding when a drug maker engages in truthful and non-misleading speech to promote the off-label use of a drug. If the decision is sustained, it could open the door for drug makers, including biosimilar applicants, to seek approval from the FDA for one indication, while retaining the ability to promote off-label uses via truthful, non-misleading communications.

Amarin sells Vascepa® (icosapent ethyl), which has been approved by the FDA to lower serum triglycerides in patients with triglyceride levels above 500 mg/dL. Lowering serum triglycerides has been reported to protect against cardiovascular events such as heart attacks. Amarin subsequently sought approval for a second indication (to treat patients with 200-499 mg/dL triglycerides), and conducted clinical trials that showed that Vascepa lowered serum triglycerides in those patients. The FDA ultimately denied Amarin’s second application because other recent studies questioned whether lowering a patient’s serum triglycerides actually protected against cardiovascular events. Further, the FDA refused to allow Amarin to use the clinical trial results—that Vascepa effectively lowered serum triglycerides— in the Vascepa label or marketing materials, threatening Amarin with misbranding charges if it did so.

Amarin sought a declaratory judgment that the First Amendment protected truthful and non-misleading commercial speech, even when used in promotion of an off-label use. The District Court granted Amarin’s request for a preliminary injunction, and enjoined the FDA from prosecuting Amarin for misbranding.

An appeal is likely to follow, and we will bring you updates as this case proceeds.

Download PDF

Comments are closed.