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Investigator publications listed on this site relate to research funded through the Investigator Awards program. References are provided for books and selected journal articles written by the investigators. Abstracts are available for some featured publications.
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Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA
Carpenter, D.P.
Published: 2010
Princeton University Press
»Show summary
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.

Daniel P. Carpenter is the Allie S. Freed Professor of Government at Harvard University. He is the author of The Forging of Bureaucratic Autonomy: Reputations, Networks, and Policy Innovation in Executive Agencies, 1862-1928 (Princeton).

Endorsements:

"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

Linked Investigator Award(s):
Daniel P. Carpenter, Ph.D.Reputation and Regulation: A Study of Pharmaceutical Policy at the FDA
Award Year: 2003

»Show Abstract
As U.S. expenditures on prescription drugs continue to rise and account for a growing share of gross national product, Daniel P. Carpenter, Ph.D. examines a major institution in American health care: the U.S. Food and Drug Administration (FDA). His project, Reputation and Regulation: A Study of Pharmaceutical Policy at the FDA, considers the power the FDA exerts and how political, social, and other considerations influence its decisions. Focusing on the Center for Drug Evaluation and Research (CDER), the agency's drug reviewing division, Dr. Carpenter dissects the FDA's reputation for protecting the American public, the evolution of that role, and its impact on regulation of new drugs. Specifically, he explores how the FDA's concerns about its image and credibility affect whether drugs are approved or rejected, and whether drug development is accelerated or slowed. His work should also reveal who wins and who loses when agency self-protection motivates the making of prescription drug policy.
More Books by Author(s):
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Carpenter, D.P., Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA. Princeton, NJ: Princeton University Press, 2010.