DTC Prescription Drug Advertising: The History and Impact of FDA Regulation

Abstract

This paper traces the history of direct-to-consumer (DTC) advertising for prescription drugs in the United States, beginning with the enactment of the Federal Food, Drug, and Cosmetics Act in 1938 and continuing through the current state of FDA regulation. A detailed analysis of how the promulgation of DTC ads has affected a variety of groups (including consumers, the medical profession, pharmaceutical companies, the government, and advertisers) is followed by a brief look at a well-known DTC ad campaign (Schering-Plough’s Claritin). The paper questions whether DTC ads are a constructive or a deconstructive element of the American healthcare system and concludes by offering an opinion on the current state of DTC advertising regulation and enforcement by the FDA.