Description
Book SynopsisThe US Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? This book 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.
Trade ReviewWinner of the 2011 Allan Sharlin Memorial Award, Social Science History Association "Reputation and Power is ... and authoritative and well researched book. Political scientists will admire Carpenter's scholarship. It is, indeed, a good mix of history, politics, gossip, and intrigue."--Michael Rawlins, Lancet "In his massive, magisterial Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA, the Harvard political scientist Daniel Carpenter provides both a history of the agency and an analysis of how it gained and flexed its most important regulatory power, the ability to keep new drugs off the market. Carpenter carefully documents the ways FDA bureaucrats have worked to exploit opportunities to expand their influence and reshape how the drug industry and the medical profession operate."--Keith E. Wittington, Reason "This immense volume considers the Food and Drug Administration's regulation of the pharmaceutical industry, focusing on the connection between the FDA's stellar reputation and its ability to wield power as a regulatory body. The book is exceptional, successfully combining an array of methodological approaches."--Choice "Carpenter's book has much to offer. Reputation and Power will be a valuable resource for anyone who is interested in understanding US pharmaceutical regulation and the debates surrounding it."--Mary K. Olson, Health Affairs "This book succeeds quite well in achieving its ambitious objectives. It provides a compelling and useful account for the exceptional role of the FDA in American society, government, and regulation. Perhaps more importantly for organizational scholars, it provides a very rich case study of the evolution of an organization's reputation, image and power and how these combine to affect its performance."--Thomas D'Aunno, Administrative Science Quarterly "Carpenter's book was ten years in the making and it shows. The research is wide ranging and groundbreaking and the impressive range of materials will certainly help expand the field... Reputation and Power is essential reading for modern historians of medicine. In a renewed climate of interest in regulation, it is a sober addition to the previous polemical debates about the world of pharmaceuticals and their regulation and is sure to generate a broad discussion."--Lucas Richert, Social History of Medicine "Reputation and Power ... is a masterful study in the best tradition of political science and will stand as a definitive treatment of regulation, and not merely of the FDA's policies and practices. Along with his earlier work, this book will be an essential part of the emerging study of the American administrative state, whether that study takes place in political science, history, sociology, law, or, indeed, in schools of medicine and pharmacology."--John Ferejohn, Perspectives on Politics
Table of ContentsLIST OF ILLUSTRATIONS ix LIST OF TABLES xi ACKNOWLEDGMENTS xiii LIST OF ABBREVIATIONS AND ACRONYMS xvii INTRODUCTION: The Gatekeeper 1 CHAPTER ONE: Reputation and Regulatory Power 33 PART ONE: ORGANIZATIONAL EMPOWERMENT AND CHALLENGE CHAPTER TWO: Reputation and Gatekeeping Authority: The Federal Food, Drug and Cosmetic Act of 1938 and Its Aftermath 73 CHAPTER THREE: The Ambiguous Emergence of American Pharmaceutical Regulation, 1944-1961 118 CHAPTER FOUR: Reputation and Power Crystallized: Thalidomide, Frances Kelsey, and Phased Experiment, 1961-1966 228 CHAPTER FIVE: Reputation and Power Institutionalized: Scientific Networks, Congressional Hearings, and Judicial Affirmation, 1963-1986 298 CHAPTER SIX: Reputation and Power Contested: Emboldened Audiences in Cancer and AIDS, 1977-1992 393 PART TWO: PHARMACEUTICAL REGULATION AND ITS AUDIENCES CHAPTER SEVEN: Reputation and the Organizational Politics of New Drug Review 465 CHAPTER EIGHT: The Governance of Research and Development: Gatekeeping Power, Conceptual Guidance, and Regulation by Satellite 544 CHAPTER NINE: The Other Side of the Gate: Reputation, Power, and Post-Market Regulation 585 CHAPTER TEN: The Detente of Firm and Regulator 635 CHAPTER ELEVEN: American Pharmaceutical Regulation in International Context: Audiences, Comparisons, and Dependencies 686 CHAPTER TWELVE: Conclusion: A Reputation in Relief 727 PRIMARY SOURCES AND ARCHIVAL COLLECTIONS 753 INDEX 759
