FDA, Amarin settle off-label promotion case

Settling a landmark free speech lawsuit, FDA agreed to allow Amarin Corp. plc (NASDAQ:AMRN) to make truthful, non-misleading statements about off-label use of Vascepa icosapent ethyl to treat persistently high triglycerides. The settlement implements a preliminary injunction the U.S. District Court for the Southern District of New York issued in August (see BioCentury, Oct. 26, 2015).

Under the settlement's terms, FDA agreed that truthful, non-misleading promotion of Vascepa "may not form the basis of a prosecution for misbranding," and that statements the court approved in August meet the truthful, non-misleading standard. ...