Modernizing The FDA: An Incremental Revolution

PROLOGUE: In November 1997 Congress passed a sweeping reform of one of the nation's oldest public health laws: the Federal Food, Drug, and Cosmetic Act. Unlike past legislation aimed at the Food and Drug Administration (FDA), the Food and Drug Administration Modernization Act (FDAMA) affects most of the products that the agency regulates—foods, drugs, and medical devices. Implementing the new law, in a span of eighteen to twenty-four months, “is one of the most demanding challenges faced by the agency in its 92-year history,” the FDA stated last summer in a Message to FDA Stakeholders ( www.fda.gov/oc/fdama/comm/message.htm , 22 July 1998). In this paper Richard Merrill, a long-time expert on and former chief counsel to the FDA, assesses the new law's impact on the agency's responsibilities. In his view, the legislation represents a new level of congressional fine-tuning of the agency's charter, giving it new authorities but also detailed instructions as to how it is to carry out its expanded mission. This reflects a more general propensity on the part of Congress to limit agencies’ discretion and control their operations more tightly. Merrill is Daniel Caplin Professor of Law at the University of Virginia School of Law in Charlottesville. He holds a law degree from Columbia University and studied at Oxford as a Rhodes Scholar in the 1960s. In the early 1990s he served on the Health and Human Services (HHS) Secretary's Advisory Committee on the Food and Drug Administration and as chair of the Institute of Medicine (IOM) Committee on the Nutrition Components of Food Labeling. He has been an IOM member since 1977. ABSTRACT: The U.S. Food and Drug Administration (FDA) is responsible for protecting consumers from unsafe or ineffective drugs and medical devices. The agency's role is defined by a growing and increasingly complex set of statutes, which reflect Congress's desires, on the one hand, to prevent product hazards and, on the other, to expedite FDA review and approval of promising new medical technologies. Congress's latest attempt to calibrate regulation to achieve these goals, the 1997 Food and Drug Administration Modernization Act, endorses certain of the FDA's own innovations and changes in the agency's ways of doing business.