Truth or Consequences: The Perils and Protection of Off-Label Drug and Medical Device Promotion

Abstract:     
Off-label prescribing is an essential component of good medical care, and it offers greater choice in treatment options for millions of patients. Food and Drug Administration rules prohibit manufacturers from disseminating most information about off-label uses, though, making it difficult for doctors and their patients to learn about important therapeutic options. The prohibition on truthful and non-misleading speech raises constitutionality questions, which have not yet been fully explored by courts. This paper examines the role of off-label prescribing in medical practice and the regulation of off-label promotion. It also discusses the scope of permissible commercial speech regulation and analyzes the constitutionality of off-label speech restrictions in light of applicable case law. It concludes that the FDA’s ban on off-label promotion is unconstitutional, but suggests less burdensome alternative restrictions that likely would pass constitutional muster while still advancing the government’s asserted interests.

Number of Pages in PDF File: 37

Keywords: FDA, pharmaceuticals, medical devices, off-label, commercial speech

JEL Classification: I10, I18, K23, K32, L65, M31

working papers series