Emory Corporate Governance and Accountability Review


Caroline Poplin


Dr. Poplin examines two recent federal cases, Caronia v. FDA and FDA v. Amarin, in which courts held that the First Amendment protects pharmaceutical manufacturers who market their drugs off-label as long as the advertising is 'truthful and non-misleading.' In so doing, these courts essentially overturned restrictions Congress imposed in 1962, after the thalidomide disaster. The drug at issue in Caronia is particularly dangerous'it is closely related to a date-rape drug, and was approved for a narrow indication. The defendant sales representative nonetheless said the drug was 'very safe', and recommended it for a variety of common diseases, including Parkinson's and insomnia. Today, however, the medical community requires rigorous evidence to determine the truth of any proposition. Yet these courts found the manufacturers' statements 'truthful and non-misleading' without any evidence at all. Dr. Poplin concludes that decisions about drug advertising are best left to an independent expert agency, the FDA.