Second Circuit Delivers Blow to Off-Label Promotion Prosecutions in U.S. v. Caronia


In a much-anticipated decision, a federal court of appeals has ruled that the government cannot criminally prosecute pharmaceutical manufacturers and their representatives under the Food, Drug and Cosmetics Act (“FDCA”) for truthful, non-misleading speech promoting the off-label uses of FDA-approved drugs. On December 3, 2012, the Second Circuit reversed the conviction of Alfred Caronia, a pharmaceutical sales representative, for conspiracy to introduce a misbranded drug into interstate commerce, in violation of the FDCA. Over a strong dissent, the majority held that Caronia’s conviction for off-label promotion of the drug Xyrem violated his constitutional right of free speech under the First Amendment. The Caronia decision seriously challenges the legal underpinnings of the government’s prosecution of off-label promotion, but is unlikely to signal a retreat from ongoing aggressive enforcement by the government.


The FDA does not regulate the practice of medicine, and nothing prohibits physicians from prescribing drugs and devices off-label (i.e., for uses not approved by the FDA). In fact, physicians widely employ off-label uses, particularly in specialties such as oncology and pediatrics. In order to balance the risks and benefits of off-label uses, physicians need reliable and up-to-date scientific information concerning such uses. Drug and device manufacturers are an important source for such information. The government, however, fears that allowing the free flow of such information will encourage companies to bypass the regulatory approval process and undermine the FDA’s mission to ensure the safety and efficacy of drugs and devices. In recent years, a steady stream of criminal prosecutions has been based on the premise that off-label promotion constitutes “misbranding” under the FDCA.2 In short, the government considers drugs and devices marketed for an unapproved use to be misbranded because their labeling cannot include “adequate directions for use” for the off-label use. Precisely what manufacturers can and cannot say and do in connection with physicians’ off-label uses of their products before crossing the line into “promotion” is often unclear. As a result, companies must resort to monitoring the latest multimillion dollar settlements to determine where the government is drawing those lines.

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