Direct-to-Consumer Advertising of Prescription Drugs: Emerging Legal and Regulatory Issues

Abstract

Is direct-to-consumer (DTC) advertising a gold mine or mine field for pharmaceutical manufacturers? It seems to be a little of both.

Consumerism has proliferated in recent decades, as the public has sought more information about health care, medications, and medical issues in general. The General Accounting Office (GAO) estimated that at least 8.5 million Americans each year request and receive prescriptions for specific drugs after seeing or hearing advertisements for these products.¹ Proponents of DTC advertising argue that it gives consumers the information they need to discuss treatment options with their physicians and can play an important role in improving health care. Opponents are concerned that these ads are misleading, that they fail to communicate risks, that they lead to drug overuse, and that their costs elevate drug prices — thereby adding to the costs of prescription drugs and fueling the rising cost of health care.¹

In 1999, the first lawsuit was brought against a pharmaceutical company in connection with DTC advertising. Other cases have followed, with a significant impact on pharmaceutical product liability law. Civil liability has emerged from DTC advertisements of prescription drugs in print, broadcast, promotional, and cyberspace materials. Proposed legislative or regulatory limitations on DTC advertising have raised both First Amendment and public policy issues.

Keywords

direct-to-consumer advertising FDA regulation legal issues

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