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
Date Written: September 11, 2017
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
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