Reputation and Power: Organizational Image and Pharmaceutical Regulation at the

Description: FREE SHIPPING UK WIDE Reputation and Power by Daniel Carpenter The 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 agencys organizational reputation has been the primary source of its power, yet also one of its ultimate constraints. FORMAT Paperback LANGUAGE English CONDITION Brand New Publisher Description 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 agencys 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 FDAs 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 FDAs 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. Notes In this truly splendid, magisterial study, Carpenter thoroughly documents and narrates the FDAs 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 FDAs 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 FDAs drug approval system without taking account of Carpenters 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" Back Cover "In this truly splendid, magisterial study, Carpenter thoroughly documents and narrates the FDAs 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 FDAs 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 FDAs drug approval system without taking account of Carpenters 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 Flap "In this truly splendid, magisterial study, Carpenter thoroughly documents and narrates the FDAs 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 FDAs 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 FDAs drug approval system without taking account of Carpenters 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 Author Biography Daniel P. 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, 1862-1928 (Princeton). Table of Contents LIST 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 Review Winner 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 Carpenters 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 Administrations regulation of the pharmaceutical industry, focusing on the connection between the FDAs stellar reputation and its ability to wield power as a regulatory body. The book is exceptional, successfully combining an array of methodological approaches."--Choice "Carpenters 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 organizations reputation, image and power and how these combine to affect its performance."--Thomas DAunno, Administrative Science Quarterly "Carpenters 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 FDAs 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 Promotional In this truly splendid, magisterial study, Carpenter thoroughly documents and narrates the FDAs 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 FDAs 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 FDAs drug approval system without taking account of Carpenters 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" Prizes Winner of Allan Sharlin Memorial Award 2011 Long Description 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 agencys 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 FDAs 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 FDAs 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. Review Quote Winner of the 2011 Allan Sharlin Memorial Award, Social Science History Association Details ISBN0691141800 Short Title REPUTATION & POWER Publisher Princeton University Press Language English ISBN-10 0691141800 ISBN-13 9780691141800 Media Book Format Paperback Year 2010 Imprint Princeton University Press Subtitle Organizational Image and Pharmaceutical Regulation at the FDA Place of Publication New Jersey Country of Publication United States Pages 856 Publication Date 2010-05-02 Translated from English UK Release Date 2010-05-02 NZ Release Date 2010-05-02 US Release Date 2010-05-02 Author Daniel Carpenter Alternative 9780691141794 DEWEY 322.30973 Illustrations 13 halftones. 17 line illus. 13 tables. Audience Tertiary & Higher Education AU Release Date 2010-07-11 Series Princeton Studies in American Politics We've got this At The Nile, if you're looking for it, we've got it. With fast shipping, low prices, friendly service and well over a million items - you're bound to find what you want, at a price you'll love! 30 DAY RETURN POLICY No questions asked, 30 day returns! FREE DELIVERY No matter where you are in the UK, delivery is free. SECURE PAYMENT Peace of mind by paying through PayPal and eBay Buyer Protection TheNile_Item_ID:161691477;

Price: 68.58 GBP

Location: London

End Time: 2025-01-03T06:05:04.000Z

Shipping Cost: 6.98 GBP