Amarin, FDA may settle free speech case

According to a court filing, Amarin Corp. plc (NASDAQ:AMRN) and FDA have "agreed to explore the possibility of settlement" of Amarin's suit against FDA and requested a stay of further proceedings until Oct. 30, when the parties will advise the court of their views on next steps.

Amarin had filed suit in May, claiming that limitations on off-label promotion of its cardiovascular drug Vascepa icosapent ethyl constitute unconstitutional infringement of its First Amendment rights. Earlier this month, the U.S. District Court for the Southern District of New York granted Amarin preliminary relief, allowing the company to engage in "truthful and non-misleading speech" under the First Amendment to promote off-label use of Vascepa (see BioCentury Extra, Aug. 7). ...