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Massachusetts Medical Society




In 2012, the U.S. Court of Appeals for the Second Circuit handed down a landmark decision in the case of pharmaceutical sales representative Alfred Caronia. The Food and Drug Administration (FDA) had approved sodium oxybate (Xyrem) for treating narcolepsy, but Caronia promoted it for a wide range of nonapproved (off-label) indications, including insomnia, Parkinson’s disease, and fibromyalgia. Off-label use is common, especially in specialties such as oncology, in which it may even be considered the standard of care. However, surveys have revealed that supporting evidence is lacking for a majority of off-label uses of medical products.1 The uses Caronia proposed were not based on high-quality data and were likely to cause patients substantial harm (sodium oxybate, or gamma-hydroxybutyrate, is also known as the “date-rape drug” in nonclinical use).

Nonetheless, because prosecutors relied on Caronia’s own words to show that he intended the drug to be used for nonapproved purposes, in violation of the Food, Drug, and Cosmetic Act (FDCA), the appeals court reversed the conviction, holding that Caronia’s sales pitches were protected commercial speech under the First Amendment.


From The New England Journal of Medicine, Christopher T. Robertson and Aaron S. Kesselheim, Regulating Off-Label Promotion — A Critical Test, Volume 375, Page 2313 Copyright © (2016) Massachusetts Medical Society. Reprinted with permission.



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