Balancing Acts: An Analysis of Food and Drug Administration Letters about Direct-to-Consumer Advertising Violations

Abstract

Traditionally, physicians have considered themselves the gatekeepers to health care and have desired (and received) tight control over information conveyed to patients. Approval by the Food and Drug Administration (FDA) of direct-to-consumer (DTC) advertising changes this dynamic. The FDA is charged with promoting public health by reviewing clinical research and by taking timely, appropriate action on the marketing of regulated products. In addition, the FDA must ensure that human drugs are safe and effective. To accomplish this, the FDA must balance drug marketers’ desires to provide persuasive advertising messages with the concerns of several other groups about the effects of DTC messages on both the cost of medical care and the quality of patient interaction. The FDA must also balance these concerns with First Amendment protection of commercial speech. This study investigates the FDA's perceptions of the problems with DTC advertising. To accomplish this, the author examines FDA letters to pharmaceutical manufacturers about concerns about advertising messages that do not meet the guidelines established by the FDA. The author also provides suggestions about where the FDA should put its resources to best address these concerns: enhanced guidelines, consumer involvement, and intra-agency cooperation.