Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA: Organizational Image and Pharmaceutical Regulation at the FDA

Product Description 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. Review "In his massive, magisterial Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA, the Harvard political scientist Daniel Carpenter provides both a history of the agency and an analysis of how it gained and flexed its most important regulatory power, the ability to keep new drugs off the market. Carpenter carefully documents the ways FDA bureaucrats have worked to exploit opportunities to expand their influence and reshape how the drug industry and the medical profession operate." ---Keith E. Wittington, Reason "Carpenter's book was ten years in the making and it shows. The research is wide ranging and groundbreaking and the impressive range of materials will certainly help expand the field. . . . Reputation and Power is essential reading for modern historians of medicine. In a renewed climate of interest in regulation, it is a sober addition to the previous polemical debates about the world of pharmaceuticals and their regulation and is sure to generate a broad discussion." ---Lucas Richert, Social History of Medicine "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 "This book succeeds quite well in achieving its ambitious objectives. It provides a compelling and useful account for the exceptional role of the FDA in American society, government, and regulation. Perhaps more importantly for organizational scholars, it provides a very rich case study of the evolution of an organization's reputation, image and power and how these combine to affect its performance." ---Thomas D'Aunno, Administrative Science Quarterly "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 " Reputation and Power