FDA clarifies position on Amarin's free-speech suit

A lawsuit Amarin Corp. plc (NASDAQ:AMRN) filed last month against FDA has elicited a response from the agency that clarifies its policies on manufacturers disseminating information about off-label uses of their drugs.

Amarin's suit alleges that FDA regulations violate the First Amendment to the U.S. Constitution because they have prevented the company from providing "truthful and non-misleading information" to healthcare professionals about off-label use of Vascepa icosapent ethyl, derived from fish oil, to treat cardiovascular disease (see BioCentury Extra, May 8). ...