Reputation and power organizational image and pharmaceutical regulation at the FDA / Daniel Carpenter.

Format:

Book

Author/Creator:

Carpenter, Daniel P., 1967-

Series:

Princeton studies in American politics.

Princeton studies in American politics

Language:

English

Subjects (All):

United States. Food and Drug Administration.

United States.

Pharmaceutical policy--United States.

Pharmaceutical policy.

Drugs--Research--United States.

Drugs.

Physical Description:

1 online resource (825 p.)

Edition:

Course Book

Place of Publication:

Princeton : Princeton University Press, c2010.

Language Note:

English

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 re

Contents:

Cover; CONTENTS; LIST OF ILLUSTRATIONS; LIST OF TABLES; ACKNOWLEDGMENTS; LIST OF ABBREVIATIONS AND ACRONYMS; INTRODUCTION: The Gatekeeper; CHAPTER ONE: Reputation and Regulatory Power; PART ONE: ORGANIZATIONAL EMPOWERMENT AND CHALLENGE; CHAPTER TWO: Reputation and Gatekeeping Authority: The Federal Food, Drug and Cosmetic Act of 1938 and Its Aftermath; CHAPTER THREE: The Ambiguous Emergence of American Pharmaceutical Regulation, 1944-1961; CHAPTER FOUR: Reputation and Power Crystallized: Thalidomide, Frances Kelsey, and Phased Experiment, 1961-1966

CHAPTER FIVE: Reputation and Power Institutionalized: Scientific Networks, Congressional Hearings, and Judicial Affirmation, 1963-1986CHAPTER SIX: Reputation and Power Contested: Emboldened Audiences in Cancer and AIDS, 1977-1992; PART TWO: PHARMACEUTICAL REGULATION AND ITS AUDIENCES; CHAPTER SEVEN: Reputation and the Organizational Politics of New Drug Review; CHAPTER EIGHT: The Governance of Research and Development: Gatekeeping Power, Conceptual Guidance, and Regulation by Satellite; CHAPTER NINE: The Other Side of the Gate: Reputation, Power, and Post-Market Regulation

CHAPTER TEN: The Détente of Firm and RegulatorCHAPTER ELEVEN: American Pharmaceutical Regulation in International Context: Audiences, Comparisons, and Dependencies; CHAPTER TWELVE: Conclusion: A Reputation in Relief; PRIMARY SOURCES AND ARCHIVAL COLLECTIONS; INDEX

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

ISBN:

9786612639487

9781282639485

128263948X

9781400835119

1400835119

OCLC:

655342133