The Indirect Consequences of Expanded Off-Label Promotion
46 Pages Posted: 8 Sep 2017 Last revised: 2 Feb 2018
Date Written: August 1, 2017
The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs — when a manufacturer promotes a drug for a use for which the FDA has not approved it — leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that — as suggested in the dissenting opinion in United States v. Caronia, a high-profile 2012 case regarding off-label promotion — protections for off-label promotion might affect the FDA’s decision-making in areas other than drug promotion, and analyzes precisely what those effects could be in light of the FDA’s current statutory authority.
Keywords: FDA, Food and Drug Law, Administrative Law, First Amendment, Commercial Speech, Off-Label Promotion
JEL Classification: I18, K23, K39
Suggested Citation: Suggested Citation