Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton Studies in American Politics: Historical, International, and Comparative Perspectives) - Softcover

Carpenter, Daniel

Softcover

ISBN 10: 0691141800 ISBN 13: 9780691141800

Verlag: Princeton University Press, 2010

Inhaltsangabe

How the FDA became the world's most powerful regulatory agency 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 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 Power demonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested.

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Daniel Carpenter

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"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

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Reputation and Power

ORGANIZATIONAL IMAGE AND PHARMACEUTICAL REGULATION AT THE FDABy DANIEL CARPENTER

PRINCETON UNIVERSITY PRESS

Copyright © 2010 Princeton University Press
All right reserved.
ISBN: 978-0-691-14180-0

Contents

LIST OF ILLUSTRATIONS.....................................................................................................................................ixLIST OF TABLES............................................................................................................................................xiACKNOWLEDGMENTS...........................................................................................................................................xiiiLIST OF ABBREVIATIONS AND ACRONYMS........................................................................................................................xviiINTRODUCTION The Gatekeeper..............................................................................................................................1CHAPTER ONE Reputation and Regulatory Power...............................................................................................................33CHAPTER TWO Reputation and Gatekeeping Authority: The Federal Food, Drug and Cosmetic Act of 1938 and Its Aftermath.......................................73CHAPTER THREE The Ambiguous Emergence of American Pharmaceutical Regulation, 1944-1961....................................................................118CHAPTER FOUR Reputation and Power Crystallized: Thalidomide, Frances Kelsey, and Phased Experiment, 1961-1966.............................................228CHAPTER FIVE Reputation and Power Institutionalized: Scientific Networks, Congressional Hearings, and Judicial Affirmation, 1963-1986.....................298CHAPTER SIX Reputation and Power Contested: Emboldened Audiences in Cancer and AIDS, 1977-1992............................................................393CHAPTER SEVEN Reputation and the Organizational Politics of New Drug Review...............................................................................465CHAPTER EIGHT The Governance of Research and Development: Gatekeeping Power, Conceptual Guidance, and Regulation by Satellite.............................544CHAPTER NINE The Other Side of the Gate: Reputation, Power, and Post-Market Regulation....................................................................585CHAPTER TEN The Dtente of Firm and Regulator.............................................................................................................635CHAPTER ELEVEN American Pharmaceutical Regulation in International Context: Audiences, Comparisons, and Dependencies......................................686CHAPTER TWELVE Conclusion: A Reputation in Relief.........................................................................................................727PRIMARY SOURCES AND ARCHIVAL COLLECTIONS..................................................................................................................753INDEX.....................................................................................................................................................759

Chapter One

Reputation and Regulatory Power

In ways that are stark and in ways not easily seen, organizational reputations animate, empower, and constrain the manifold agencies of government. Reputations are composed of symbolic beliefs about an organization-its capacities, intentions, history, mission-and these images are embedded in a network of multiple audiences. From military bodies and diplomatic establishments to disaster relief outfits and regulatory commissions, government agencies are buffeted and suffused by a multidimensional politics of legitimacy. Reputations can expand or deflate the legal authority that agencies exercise by virtue of law and delegation. Reputations can intimidate or embolden the subjects of government and, in so doing, reputations can complicate an agency's tasks or render them facile. Reputations can, by assigning expertise and status to government agencies, allow them to define basic terms of debate, essential concepts of thought, learning, and activity. In its directive facets, its gatekeeping facets, and its conceptual facets, regulatory power depends profoundly upon the image of state organizations.

The central concept in a reputation-based perspective on regulation is that of audience. An audience is any individual or collective that observes a regulatory organization and can judge it. Put most simply, audiences shape regulation in two ways. First, various audiences empower or weaken the regulator. Audiences such as legislatures can grant authority to the regulator. Audiences such as firms and regulated individuals can convey power by obeying the regulator's rules and suggestions, or contest power by challenging those precepts. Audiences such as scientific and professional organizations, firms, and institutions of learning can grant conceptual power to the regulator by accepting the agency's definitions of technical terms and concepts. These audiences also reproduce the regulator's definitions by using them as if they were natural or "purely" scientific, rather than as a partially regulatory creation. Second, regulatory organizations and their members adapt to their audiences. They adapt behavior and rhetoric. They adapt both consciously and unconsciously, in ways that are dynamically planned and in ways they may scarcely recognize. Patterns of anticipation and reaction to audience can in fact permit scholars to systematically interpret and explain regulatory behavior, in ways that scholars using other theories and models cannot.

Matters are of course more complicated than this simple portrait suggests. Government agencies live among numerous audiences, and these audiences overlap and blend into one another. Audiences include the political and judicial authorities who endow organizations with power; interest groups and civic associations; organizations of professional and scientific expertise; media syndicates in print and broadcast, and the mass publics who digest the information produced by these syndicates; the companies, corporations, and citizens who are governed by agencies; the clienteles who rely upon agencies for benefits and for order. In political systems like the United States-with formal separation of powers among legislative, executive, and judicial branches; with federalist structures that multiply and refract government capacity; and with pluralist political structures that often scatter the forces of business, labor, religion, race, and ethnicity-these audiences stand ever more diffuse.

Another central complication is that what one audience sees is not necessarily what another audience sees. Within and between the audiences of government there flow opaque and symbolic beliefs about the agency-its intentions, its authenticity and legality, its capacities and weaknesses, its unity or disunity, its most historic achievements and most enduring failures, its likely actions in the next day, year, or decade. In part because perception differs across audiences, so does judgment. These images and judgments shape the power of government organizations, and more broadly, the powers of the state.

The powers of government depend in enduring ways upon organizational vessels of state and their collective images. This pattern is especially relevant in government regulation of social and economic behavior. In the sort of government regulation that is practiced in democratic republics, generally small...

Details zur Ausgabe

• Verlag: Princeton University Press
• Erscheinungsdatum: 2010
• Sprache: Englisch
• ISBN 10: 0691141800
• ISBN 13: 9780691141800
• Einband: Taschenbuch
• Anzahl der Seiten: 826
• Kontakt zum Hersteller: Nicht verfügbar
• Verantwortliche Person: gpsr@libri.de; gpsr@libri.de; ; Europaallee 1; Bad Hersfeld; 36244; Deutschland