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(More customer reviews)This is a masterful work. Carpenter examines the historical development of FDA power. He shows how it leveraged crises to increase its own power; but that it did so only after it had developed substantial expertise, procedures, and networks. He notes first that the FDA is (was) an extraordinarily strong bureaucracy; the seems at odds with conventional explanations of the United States as having a weak administrative state. He argues that traditional political science explanations, such as agency capture, do not explain how the FDA could achieve this. Instead, he suggests that a reputation-based analysis gets us much further.
The book has two parts. The first part is an in-depth examination of the accumulation of power. It includes analysis the agency norms, and how it established a gatekeeping power. In the 1930's "nostrums" could be marketed at will. By the 1960's, they had to go through testing procedures and efficacy standards established by the FDA. The second part examines how the politics of reputation interacts with firms, academics, teaching hospitals, and members of Congress in various stages of the drug-approval process, including the pre- and post-approval stages. The FDA has managed to alter the behavior of firms, including how they conduct experiments (such as 3 phases of testing), who is accredited to run the experiments, what controls must be used, and what paperwork must be kept to document findings.
The range of sources, and the amount of evidence collected in this work is astonishing. Further, his theory of reputation and networks has a wide range of applicability.
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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.
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