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

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

by Daniel Carpenter
     
 

ISBN-10: 0691141800

ISBN-13: 9780691141800

Pub. Date: 04/29/2010

Publisher: Princeton University Press

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

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Overview

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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Product Details

ISBN-13:
9780691141800
Publisher:
Princeton University Press
Publication date:
04/29/2010
Series:
Princeton Studies in American Politics: Historical, International, and Comparative Perspectives Series
Pages:
856
Sales rank:
772,462
Product dimensions:
5.90(w) x 9.20(h) x 2.00(d)

Table of Contents

List of Illustrations ix

List of Tables xi

Acknowledgments xiii

List of Abbreviations and Acronyms xvii

Introduction: The Gatekeeper 1

Chapter 1 Reputation and Regulatory Power 33

Part 1 Organizational Empowerment and Challenge

Chapter 2 Reputation and Gatekeeping Authority: The Federal Food, Drug and Cosmetic Act of 1938 and Its Aftermath 73

Chapter 3 The Ambiguous Emergence of American Pharmaceutical Regulation, 1944–1961 118

Chapter 4 Reputation and Power Crystallized: Thalidomide, Frances Kelsey, and Phased Experiment, 1961–1966 228

Chapter 5 Reputation and Power Institutionalized: Scientific Networks, Congressional Hearings, and Judicial Affirmation, 1963–1986 298

Chapter 6 Reputation and Power Contested: Emboldened Audiences in Cancer and AIDS, 1977–1992 393

Part 2 Pharmaceutical Regulation and Its Audiences

Chapter 7 Reputation and the Organizational Politics of New Drug Review 465

Chapter 8 The Governance of Research and Development: Gatekeeping Power, Conceptual Guidance, and Regulation by Satellite 544

Chapter 9 The Other Side of the Gate: Reputation, Power, and Post-Market Regulation 585

Chapter 10 The Détente of Firm and Regulator 635

Chapter 11 American Pharmaceutical Regulation in International Context: Audiences, Comparisons, and Dependencies 686

Chapter 12 Conclusion: A Reputation in Relief 727

Primary Sources and Archival Collections 753

Index 759

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