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

37 Pages Posted: 16 Sep 2010  

Gregory Conko

George Mason University Law & Economics Center

Date Written: September 2010

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.

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

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

Suggested Citation

Conko, Gregory, Truth or Consequences: The Perils and Protection of Off-Label Drug and Medical Device Promotion (September 2010). Health Matrix: Journal of Law-Medicine, Vol. 21, 2011. Available at SSRN: https://ssrn.com/abstract=1677609 or http://dx.doi.org/10.2139/ssrn.1677609

Gregory Conko (Contact Author)

George Mason University Law & Economics Center ( email )

3301 Fairfax Drive
Suite 440
Arlington, VA 22201
United States

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