Jazz Pharmaceuticals neurology news
FDA said in a statement that the government decided not to seek further review of a December decision that found that the federal government could not prosecute a sales representative for speech promoting the legal, off-label use of an FDA-approved drug. According to the statement, the agency does not believe the 2-1 decision from the U.S. Court of Appeals for the Second Circuit in United States v. Caronia "will significantly affect the agency's enforcement of the drug misbranding provisions" of the Food, Drug and Cosmetic Act (FDCA). FDA added that the decision "does not strike down any provision [of FDCA] or its implementing regulations, nor does it find a conflict between the act's misbranding provisions and the First Amendment or call into question the validity of the act's drug approval framework."
The appeals court said in the 2-1 ruling that 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." FDCA prohibits misbranding, but does not expressly prohibit the promotion or marketing of drugs for off-label use (see BioCentury, Dec. 10, 2012). ...