The Tip of the Iceberg: A First Amendment Right to Promote Drugs Off-Label

44 Pages Posted: 2 Jul 2016 Last revised: 13 Oct 2016

Christopher T. Robertson

University of Arizona - James E. Rogers College of Law; Harvard University - Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

Date Written: October 12, 2016

Abstract

Scholars, advocates, and courts have begun to recognize a First Amendment right for the makers of drugs and medical devices to promote their products “off-label”, without proving safety and efficacy of new intended uses. Yet, so far, this debate has occurred in a vacuum of peculiar cases, where convoluted commercial speech doctrine underdetermines the outcome. Juxtaposing these cases against other routine prosecutions of snake oil salespeople reveals the common legal regime now at issue. Review of the seven arguments deployed in the off-label domain finds that, if they were valid, they would undermine the FDA’s entire premarket approval regime. Even more, if valid, this First Amendment logic would undermine a wide range of statutory regimes that have similar intent-based structures and that rely on speech as evidence of intent.

Keywords: First Amendment, FDA, pre-market approval, drugmakers, medical devices, off-label, regulation, commercial speech, regulatory regimes

Suggested Citation

Robertson, Christopher T., The Tip of the Iceberg: A First Amendment Right to Promote Drugs Off-Label (October 12, 2016). Ohio State Law Journal, 2017, Forthcoming; Arizona Legal Studies Discussion Paper No. 16-19. Available at SSRN: https://ssrn.com/abstract=2803315

Christopher T. Robertson (Contact Author)

University of Arizona - James E. Rogers College of Law ( email )

P.O. Box 210176
Tucson, AZ 85721-0176
United States

HOME PAGE: http://www.law.arizona.edu/faculty/getprofile.cfm?facultyid=714

Harvard University - Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics ( email )

23 Everett Street
Cambridge, MA 02155
United States

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