American journal of law & medicine
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This article provides an overview of how the constitutional protections for commercial speech affect the Food and Drug Administration's (FDA) regulation of drugs, and the emerging issues about the scope of these protections. A federal district court has already found that commercial speech allows manufacturers to distribute reprints of medical articles about a new off-label use of a drug as long as it contains disclosures to prevent deception and to inform readers about the lack of FDA review. This paper summarizes the current agency guidance that accepts the manufacturer's distribution of reprints with disclosures. ⋯ Violations of the Federal Food Drug and Cosmetic Act (FFDCA) can be considered violations of the False Claims Act, which opens the way to fraud and abuse suits. The scale of penalties involved in these suits may lead to more examination of the scope of FDA regulation and commercial speech protections. Thus this symposium's consideration of these issues is timely and important.