FDA May Cut Its Losses In Amarin Off-Label Promotion Case

07 Sep 2015

Amarin and FDA explore settlement of Vascepa suit. The agency could allow Amarin to proceed with its statements and disclosures rather than risk a difficult appeal to the Second Circuit, the same court that handed FDA a loss in Caronia three years ago.

FDA's exploration of a legal settlement with Amarin Corp. PLC involving statements about off-label use of Vascepa (icosapent ethyl) suggests the agency is not interested in appealing an adverse First Amendment ruling in the case to the Second Circuit US Court of Appeals.

Instead of making what experts predict would be a highly challenging appeal to the Second Circuit, FDA may have decided...