Amarin, FDA Seek More Time in Off-Label Promotion Lawsuit

Settlement talks in a case challenging the FDA’s authority over off-label promotion for prescription drugs continue to drag on, with both the agency and plaintiff Amarin Pharma seeking more time to resolve their differences.

Judge Paul Engelmayer of the U.S. District Court for the Southern District of New York held that Amarin has a constitutional right to promote its fish oil drug Vascepa (icosapent ethyl) for off-label uses so long as the language is truthful and nonmisleading. The company has been telling physicians that the drug can help lower triglyceride levels in patients who are already taking statins.

This is the second time the two parties in Amarin Pharma, Inc., et al. v U.S. Food and Drug Admin., et al. have asked for a delay in the case following the Aug. 31 disclosure that they were negotiating settlement terms.