District court sides with Amarin in free-speech case

The U.S. District Court for the Southern District of New York granted preliminary relief to Amarin Corp. plc (NASDAQ:AMRN) allowing the company to engage in "truthful and non-misleading speech" under the First Amendment to promote off-label use of Vascepa icosapent ethyl. The court's opinion said such speech "may not form the basis of a prosecution for misbranding."

According to Amarin's suit, FDA's interpretation of off-label promotion by a drug manufacturer as misbranding put Amarin at risk for criminal prosecution. The suit seeks a declaration that FDA's regulations are an unconstitutional infringement on its right to free speech and due process, and preliminary and permanent injunctions preventing FDA from taking action against Amarin on the basis of truthful, non-misleading speech used in off-label promotion of Vascepa. During oral arguments held in July, Amarin said that as an alternative to an injunction, effective relief could constitute a declaration that its intended communications are protected against a misbranding action. ...