Addressing the Threshold: Regulating Off-Label Drug Promotion

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

Share

Authors

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

Download

Issue

Publication details

Dates

Licence

All rights reserved

File Checksums (MD5)

  • pdf: 9ac3da19fb2acc850fe81e4e24cb756b