Reputation and Power

In this truly splendid, magisterial study, Carpenter thoroughly documents and narrates the FDA's struggle with the certainties of science, the uncertainties of politics, and the requirements of reputation, an asset that simultaneously granted the agency autonomy and then took it away through ever-increasing expectations of performance. -- Richard Bensel, Cornell University Deeply researched and subtly conceived, Reputation and Power demonstrates how much our modern system of drug regulation and clinical research owes to the scientific creativity and political skills of federal drug regulators over the past sixty years. It will be the standard work on the FDA for decades to come, while providing instructive lessons for how one can think critically about government regulation without recourse to the ideological lenses of the Left or the Right. -- Harry M. Marks, history of medicine, Johns Hopkins University Reputation and Power is by far the most thorough and penetrating study of the most powerful and important regulatory agency in the world--the U.S. Food and Drug Administration--and one of the best studies of any American regulatory agency. The book is essential reading for anyone seriously interested in American politics, public policy, administrative institutions, or health and medicine. This is an extraordinary work. -- Paul Quirk, University of British Columbia Carpenter has integrated an understanding of the FDA's legal history and programmatic responsibilities with a perceptive grasp of the personalities who shaped that history. His work surpasses in depth and scope all other accounts of the FDA with which I am familiar. No one in the future will be able to write seriously about the FDA's drug approval system without taking account of Carpenter's work. His curiosity knows no limits. -- Richard A. Merrill, professor emeritus, University of Virginia, former FDA general counsel, and coauthor of "Food and Drug Law: Cases and Materials"

The US Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? This book traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints.The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Reputation and Power traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints. Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today. Reputation and Power demonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested.