Forbidden and Permitted Statements About Medications—Loosening the Rules

A federal court ruling in 2015 sided with Amarin Pharmaceutical’s claim that the First Amendment protects its right to promote its fish oil product Vascepa for an unapproved indication, provided the statements are “truthful,” representing the latest in a series of legal and regulatory developments weakening FDA authority over off-label drug promotion. The authors examine how this expanding interpretation of commercial speech rights threatens the longstanding regulatory tradition of requiring manufacturers to demonstrate efficacy before making promotional claims, with potentially significant implications for patient safety and evidence-based prescribing.