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After Caronia: First Amendment Concerns In Off-Label Promotion, Stephanie M. Greene

San Diego Law Review

The government has successfully prosecuted pharmaceutical companies for off-label promotion of drugs, maintaining that such promotion impermissibly undermines the FDA’s premarket approval process and jeopardizes the public health. In several recent cases, however, pharmaceutical companies have alleged that regulations prohibiting such promotion are unconstitutional because off-label promotion is protected under the First Amendment. Two recent U.S. Supreme Court cases contain language that gives broad protection to advertising and marketing in the pharmaceutical field. This Article questions the reach of these cases as applied to the practice of off-label promotion through detailing.