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

35 Pages Posted: 2 Jul 2016 Last revised: 23 Feb 2018

Date Written: February 20, 2018


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 those who peddle unapproved drugs reveals the common legal regime 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 a companion paper shows that, 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 (February 20, 2018). 78 Ohio State Law Journal 1019 (2017), Arizona Legal Studies Discussion Paper No. 16-19, Available at SSRN:

Christopher T. Robertson (Contact Author)

Boston University ( email )

765 Commonwealth Avenue
Boston, MA 02215
United States
6179100649 (Phone)
02215 (Fax)

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