Note

Addressing the Threshold: Regulating Off-Label Drug Promotion

Author: Christine Lama (J.D. 2019, Washington University School of Law)

Abstract

The Food and Drug Administration (FDA) engages in a premarketing approval process established by Congress which permits the agency to restrict the sale of prescription drugs and approve medications for a specific purpose. After a drug is approved for one specific purpose, medical professionals may discover other valuable uses for a particular drug, known as “off label uses.” This note addresses the First Amendment implications of the FDA’s general prohibition of advertising off-label uses. The note proposes the establishment of an independent agency to objectively determine whether a given advertising claim is “false or misleading,” and therefore whether or not First Amendment protection of it is warranted.

Keywords: off-label uses, Food and Drug Administration, FDA, prescription drugs, medication, First Amendment

How to Cite: Lama, C. (2019) “Addressing the Threshold: Regulating Off-Label Drug Promotion”, Washington University Journal of Law and Policy. 60(1).