Article Title

Addressing the Threshold: Regulating Off-Label Drug Promotion

Publication Title

Washington University Journal of Law & Policy


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.