The Statutory Case against Off-Label Promotion

University of Chicago Law Review Online, 2016

SMU Dedman School of Law Legal Studies Research Paper No. 371

19 Pages Posted: 13 Sep 2017 Last revised: 15 Nov 2017

Nathan Cortez

Southern Methodist University - Dedman School of Law

Date Written: September 11, 2017

Abstract

The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit companies from marketing or promoting drugs for unapproved, "off-label" uses. The FDA itself acknowledges that off-label promotion is not a "prohibited act" under the statute, or an element of any such act. Instead, the FDA uses off-label promotion as evidence of other statutory violations. This Article engages in perhaps the most thorough statutory construction analysis of the FDCA on this question, finding that the statute does support the FDA's functional ban on off-label promotion. Using various tools of construction, I find that several sections of the FDCA assume or expressly contemplate a ban on off-label promotion, and that the FDCA's regulation of medical products, as a whole, depends on such a ban.

Keywords: FDA, Drugs, Devices, Off-Label, Approval, Promotion, Marketing, Statutory Construction, Regulation

Suggested Citation

Cortez, Nathan, The Statutory Case against Off-Label Promotion (September 11, 2017). University of Chicago Law Review Online, 2016; SMU Dedman School of Law Legal Studies Research Paper No. 371. Available at SSRN: https://ssrn.com/abstract=3035413 or http://dx.doi.org/10.2139/ssrn.3035413

Nathan Cortez (Contact Author)

Southern Methodist University - Dedman School of Law ( email )

P.O. Box 750116
Dallas, TX 75275
United States
(214) 768-1002 (Phone)

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