The Indirect Consequences of Expanded Off-Label Promotion

Publication Title

Ohio State Law Journal

Authors

Patricia J. Zettler, Georgia State University College of LawFollow

Document Type

Article

Publication Date

2017

Abstract

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.

Comments

External Links

Westlaw

Recommended Citation

Patricia J. Zettler, The Indirect Consequences of Expanded Off-Label Promotion, 78 Ohio St. L.J. 1053 (2017).

Institutional Repository Citation

Patricia J. Zettler, The Indirect Consequences of Expanded Off-Label Promotion, Faculty Publications By Year 2600 (2017)
https://readingroom.law.gsu.edu/faculty_pub/2600

Volume

78

Issue

4

First Page

1053

Last Page

1097