Promotion of Unapproved Uses of Approved Drugs and Devices: An Analysis under the First Amendment

Abstract

This paper seeks (1) to provide the background necessary to understand current commercial speech jurisprudence; (2) to explore the First Amendment analysis in recent cases against FDA; (3) to examine the landscape of food and drug law and FDA’s regulation with respect to the promotion of prescription drugs and medical devices; and (4) to discuss the viability of other FDA policies on off-label promotion. In light of the recent decisions and the expansion of ways to provide information to consumers, the paper argues in favor of increased consumer access to information and the expansion of manufacturers’ ability to provide information, within certain parameters.