On August 2, 2021, the Food and Drug Administration (FDA) issued its final rule amending its medical-product “intended use” regulations. The new rule fails to adequately account for drug and device manufacturers’ First Amendment rights. The FDA’s rule identifies many types of evidence of intended use that comprise constitutionally protected speech. Under this regulatory approach, almost any statement by a manufacturer about its product may now be deemed by the agency to be an implicit promotion of that product. WLF had filed formal comments on the proposed rule reminding FDA that, under multiple federal-court decisions interpreting the First Amendment, the FDA may not consider all scientific claims about a drug or device to be presumptively untruthful or misleading. Unfortunately, the FDA’s approach to intended-use misbranding comes dangerously close to doing just that, as it fails to distinguish between true and false claims or statements.
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