Health Policy and Cardiovascular Medicine

1136 The US Food and Drug Administration (FDA) is among the oldest agencies in the federal government. Its origins can be traced back to 1862, when President Abraham Lincoln appointed a chemist, Charles M. Wetherill, to serve in the Department of Agriculture. One of the key early pieces of legislation that initiated the evolution of the FDA into its modern form was the 1906 Pure Food and Drug Act, which prohibited interstate commerce in misbranded drugs, thereby giving the FDA its first regulatory oversight over medical product labeling. The transformation of the FDA took another major step forward in 1938 with passage of the Food, Drug and Cosmetic Act, which gave the FDA authority to require evidence of safety before new drugs could be marketed. Finally, in the 1962 Kefauver-Harris Amendments, the FDA’s drug regulatory authority was expanded to require the FDA to certify drug efficacy and safety before marketing. The Medical Device Amendments in 1976 gave the FDA similar authority to certify the effectiveness and safety of high-risk medical devices before their approval. Each of these points in the FDA’s early history represented a broadening of its authority and occurred in the context of public health crises related to widely promoted unsafe or ineffective drugs or medical devices, justifying the need for greater government oversight. For example, the KefauverHarris Amendments were designed to address the proliferation of medications with poorly documented efficacy and the occurrence of severe side effects caused by some drugs, the most noteworthy example of which was the sedativeantinauseant thalidomide. The 1976 legislation was passed after >100 deaths of young women from a widely promoted, but largely untested, implantable intrauterine contraceptive device. Currently, the FDA describes its responsibilities as ensuring the safety, efficacy and security of the medical products for which it maintains oversight; advancing the public health by helping to speed innovations that make medicines more effective and safer; and helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. Given the FDA’s central role in regulating and facilitating access to the medical products that make up physicians’ therapeutic armamentarium, it is important that physicians be familiar with the processes and decisions made during drug and device development and evaluation. The purpose of this review is to discuss current FDA policies related to the approval and postmarket surveillance of new drug and biological therapies, generic drugs, and medical devices, along with the implications of these policies for clinical care, particularly in the context of cardiovascular care.