Regulation of Drugs and Devices: An Evolution

Prologue: The Food and Drug Administration (FDA) is a federal regulatory agency that has left a tangible mark on American life. Through a long, controversial, but often distinguished history y the agency has granted approval to products that it considered worthy of its imprimatur while rejecting others that failed to pass the rigorous regulatory tests applied. Of a wide variety of products that fall under its purview, pharmaceuticals and medical devices receive substantial scrutiny, although they are formally subject to different legal standards. In this essay Richard Merrill, the Daniel Caplin Professor of Law at the University of Virginia in Charlottesville, discusses the evolution of the agency's regulation of drugs and devices. As a former chief FDA counsel (1975–1977) during parts of the Ford and Carter administrations, Merrill is uniquely qualified for the task. He not only knows the agency from the inside, but he also represented the Carter administration in negotiating the content of the Medical Device Amendments of 1976 with congressional staff and directly with Rep. Paul G. Rogers, who at the time chaired the House Energy and Commerce Subcommittee on Health and the Environment. Merrill has the reputation of being an eloquent writer who deals with complex legal material in an understandable fashion. He is a member of the Institute of Medicine (IOM) of the National Academy of Sciences and previously served on its Governing Council. Merrill was a member of the IOM'S Committee to Study FDA Use of Advisory Committees and also chaired the IOM's Committee on the Nutrition Components of Food Labeling. Merrill, a Rhodes Scholar at Oxford University, graduated with honors from Columbia University and its law school. Abstract: The U.S. Food and Drug Administration's (FDA's) drug approval process has evolved from a system in which a drug could lawfully be marketed unless the FDA were able to prove that the manufacturer knew that the drug would not work for the conditions for which it was promoted to one in which drugmakers require advance approval from the agency for almost every important step in testing, production, and marketing. The more modern system for regulating medical devices is the product of amendments to the federal Food, Drug, and Cosmetic Act in 1976. In those amendments, Congress sought to create a framework for control of device technology that would also facilitate innovation. This paper suggests that, notwithstanding this aspiration, both external pressures and internal practices are inexorably bringing device regulation closer to the “drug model.”