9780691141800

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

by
  • ISBN13:

    9780691141800

  • ISBN10:

    0691141800

  • Edition: 1st
  • Format: Paperback
  • Copyright: 2010-04-01
  • Publisher: PRINCETON UNIVERSITY PRESS

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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.

Author Biography

Daniel 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, 18621928 (Princeton).

Table of Contents

List of Illustrationsp. ix
List of Tablesp. xi
Acknowledgmentsp. xiii
List of Abbreviations and Acronymsp. xvii
Introduction: The Gatekeeperp. 1
Reputation and Regulatory Powerp. 33
Organizational Empowerment and Challenge
Reputation and Gatekeeping Authority: The Federal Food, Drug and Cosmetic Act of 1938 and Its Aftermathp. 73
The Ambiguous Emergence of American Pharmaceutical Regulation, 1944–1961p. 118
Reputation and Power Crystallized: Thalidomide, Frances Kelsey, and Phased Experiment, 1961–1966p. 228
Reputation and Power Institutionalized: Scientific Networks, Congressional Hearings, and Judicial Affirmation, 1963–1986p. 298
Reputation and Power Contested: Emboldened Audiences in Cancer and AIDS, 1977–1992p. 393
Pharmaceutical Regulation and Its Audiences
Reputation and the Organizational Politics of New Drug Reviewp. 465
The Governance of Research and Development: Gatekeeping Power, Conceptual Guidance, and Regulation by Satellitep. 544
The Other Side of the Gate: Reputation, Power, and Post-Market Regulationp. 585
The Détente of Firm and Regulatorp. 635
American Pharmaceutical Regulation in International Context: Audiences, Comparisons, and Dependenciesp. 686
Conclusion: A Reputation in Reliefp. 727
Primary Sources and Archival Collectionsp. 753
Indexp. 759
Table of Contents provided by Ingram. All Rights Reserved.

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