On March 8, 2016, Amarin Pharmaceuticals, Inc. (“Amarin”) and the Food and Drug Administration (“FDA” or the “Agency”) reached a settlement agreement in a closely followed case involving Amarin’s First Amendment rights to engage in truthful and non-misleading speech promoting an off-label use of Vascepa®. Amarin and FDA had been engaged in settlement talks since last August, when Judge Engelmayer, in the Southern District of New York, granted a motion for preliminary injunction (PI) in favor of Amarin.

In the August decision, Judge Engelmayer held that FDA may not bring a misbranding action under the Food, Drug & Cosmetic Act (FD&C Act) “based on truthful promotional speech alone, consistent with the First Amendment.” Amarin Pharma, Inc. v. United States Food and Drug Administration, 119 F. Supp. 3d 196, 224 (S.D.N.Y. 2015).