Reputation and Power (ebook)

Argumento de Reputation and Power (ebook)

Winner of the 2011 Allan Sharlin Memorial Award, Social Science History Association

"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

"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

"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

"In this truly splendid, magisterial study, Carpenter thoroughly documents and narrates the FDA's struggle with the certainties of science, the uncertainties of politics, and the requirements of reputation, an asset that simultaneously granted the agency autonomy and then took it away through ever-increasing expectations of performance."--Richard Bensel, Cornell University

"Deeply researched and subtly conceived, Reputation and Power demonstrates how much our modern system of drug regulation and clinical research owes to the scientific creativity and political skills of federal drug regulators over the past sixty years. It will be the standard work on the FDA for decades to come, while providing instructive lessons for how one can think critically about government regulation without recourse to the ideological lenses of the Left or the Right."--Harry M. Marks, history of medicine, Johns Hopkins University

"Reputation and Power is by far the most thorough and penetrating study of the most powerful and important regulatory agency in the world--the U.S. Food and Drug Administration--and one of the best studies of any American regulatory agency. The book is essential reading for anyone seriously interested in American politics, public policy, administrative institutions, or health and medicine. This is an extraordinary work."--Paul Quirk, University of British Columbia

"Carpenter has integrated an understanding of the FDA's legal history and programmatic responsibilities with a perceptive grasp of the personalities who shaped that history. His work surpasses in depth and scope all other accounts of the FDA with which I am familiar. No one in the future will be able to write seriously about the FDA's drug approval system without taking account of Carpenter's work. His curiosity knows no limits."--Richard A. Merrill, professor emeritus, University of Virginia, former FDA general counsel, and coauthor of Food and Drug Law: Cases and Materials

"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

"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

"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 Affairs0LIST 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 Détente 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