Federal Preemption in the Area of Direct-to-Consumer (DTC) Advertising of Prescription Drugs

Abstract

FDA involvement in the policy space of direct-to-consumer (DTC) advertising of prescription drugs raises the question whether state-law based lawsuits based on such advertising are preempted. Congress and the Supreme Court have not provided helpful guidance. The FDA has recently taken an aggressive stance favoring preemption. The lower courts that have considered the issue in areas of (1) failure-to-warn claims, (2) fraud and false advertising claims, and (3) claims for specific relief. The lower courts have reached mixed results, though the majority seem to disfavor preemption. This paper argues that, for a variety of reasons, most state-law based claims founded on DTC advertising should be preempted under either "implied" preemption doctrine or as obstacles to the FDA's program of encouraging optimal drug use.