• Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion
  • December 11, 2012
  • Law Firm: Covington Burling LLP - Washington Office
  • On December 3, the United States Court of Appeals for the Second Circuit issued a significant opinion in United States v. Caronia, concerning the application of the First Amendment to pharmaceutical promotion. Relying in part on the Supreme Court’s opinion in Sorrell v. IMS Health, Inc., the court held that under the First Amendment, the government “cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.” This decision raises significant questions about the government’s ability to prohibit truthful, non-misleading off-label promotional speech.