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date: 24 October 2020

Abstract and Keywords

This article synthesizes and extends, in a nontechnical manner, recent research on the Food and Drug Administration (FDA). The aim is to shed light on whether the policies of the agency itself are safe and effective when measured in terms of economic efficiency. The first section provides an overview of the role of the FDA in regulating pharmaceutical drugs and medical devices. The second section surveys the existing efficiency rationales for government regulation of the information about and the quality of medical products, and then canvasses the literature for empirical studies on the effects of FDA regulation on innovation and costs. The final section examines the growing role of tort law—specifically, products liability litigation—in supplementing FDA regulation of drug quality.

Keywords: Food and Drug Administration, drug policy, economic efficiency, FDA regulation, medical device regulation, tort law, product liability, drug quality

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