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

by Carpenter, Daniel P.

• ISBN13: 9781400835119
• ISBN10: 1400835119
• Copyright: 2010-04-29
• Publisher: Princeton Univ Pr

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 Powertraces 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 Powerdemonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested.

Table of Contents

List of Illustrations	p. ix
List of Tables	p. xi
Acknowledgments	p. xiii
List of Abbreviations and Acronyms	p. xvii
Introduction: The Gatekeeper	p. 1
Reputation and Regulatory Power	p. 33
Organizational Empowerment and Challenge
Reputation and Gatekeeping Authority: The Federal Food, Drug and Cosmetic Act of 1938 and Its Aftermath	p. 73
The Ambiguous Emergence of American Pharmaceutical Regulation, 1944-1961	p. 118
Reputation and Power Crystallized: Thalidomide, Frances Kelsey, and Phased Experiment, 1961-1966	p. 228
Reputation and Power Institutionalized: Scientific Networks, Congressional Hearings, and Judicial Affirmation, 1963-1986	p. 298
Reputation and Power Contested: Emboldened Audiences in Cancer and AIDS, 1977-1992	p. 393
Pharmaceutical Regulation and Its Audiences
Reputation and the Organizational Politics of New Drug Review	p. 465
The Governance of Research and Development: Gatekeeping Power, Conceptual Guidance, and Regulation by Satellite	p. 544
The Other Side of the Gate: Reputation, Power, and Post-Market Regulation	p. 585
The Détente of Firm and Regulator	p. 635
American Pharmaceutical Regulation in International Context: Audiences, Comparisons, and Dependencies	p. 686
Conclusion: A Reputation in Relief	p. 727
Primary Sources and Archival Collections	p. 753
Index	p. 759
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