Federal Judge Lets Amarin Promote Vascepa Off-Label, Says FDA Policies Violate 1st Amendment

A federal district court judge ruled Friday (Aug. 7) in a closely watched off-label promotion case that Amarin Pharma Inc. can promote its drug Vascepa to health care professionals for off-label uses as long as the drug maker's statements are truthful and non-misleading. The ruling, applauded by the drug industry lobby, lets the drug maker make off-label statements similar to those used by a supplement maker. While the judge said his decision is specific to Vascepa, drug industry sources are...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.