Organizational Image and Pharmaceutical Regulation at the FDA
Author: Daniel Carpenter
Publisher: Princeton University Press
Category: Political Science
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. Some images inside the book are unavailable due to digital copyright restrictions.
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Organizational Image and Pharmaceutical Regulation at the FDA
Author: Daniel P. Carpenter
"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"
The topic of negotiation has turned out to be of crucial interdisciplinary interest for our understanding of what we are doing in language use. Are we exchanging meanings defined in advance and presupposing equal understanding on the basis of a rule-governed system, or are we negotiating meaning and understanding in the framework of an open dialogic universe? Negotiation, on the one hand, can be taken as the name of a specific dialogue type or action game of bargaining. On the other hand, it represents a methodological concept for describing and explaining dialogic interaction which replaces the orthodox view of pattern transference. The papers collected in this volume deal with both versions of the concept of negotiation. This volume contains a selection of papers presented at the International Conference on Pragmatics and Negotiation at Tel Aviv University and the Hebrew University of Jerusalem in June, 1999. The dialogic aspect was taken as the key concept to guide the present selection.
An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
Using Richard E. Neustadt's analytical framework of presidential power, Bowles develops five case studies around Nixon's economic policies. These analyses help readers understand the sources of Nixon's authority and power and his use of both, and demonstrate the implications of authority and power for understanding the institution of the presidency.
Beloved as a writer of exciting biographies and renowned for his philanthropic essays on almost any subject possible, Plutarch created a diverse range of works that have entertained generations of readers since the days of Imperial Rome. Delphi's Ancient Classics series provides eReaders with the wisdom of the Classical world, with both English translations and the original Greek texts. This comprehensive eBook presents the complete works of Plutarch, with beautiful illustrations, informative introductions and the usual Delphi bonus material. (Version 1) * Beautifully illustrated with images relating to Plutarch's life and works * Features the complete works of Plutarch, in both English translation and the original Greek * Concise introductions to the works * Provides the complete PARALLEL LIVES and the complete extant essays of MORALIA, for the first time in digital printing * Includes many translations previously appearing in Loeb Classical Library editions of Plutarch's works * Excellent formatting of the texts * Easily locate the biographies and treatises you want to read with individual contents tables * Features two bonus biographies - discover Plutarch's ancient world * Scholarly ordering of texts into chronological order and literary genres Please visit www.delphiclassics.com to browse through our range of exciting titles CONTENTS: The Translations PARALLEL LIVES MORALIA The Greek Texts LIST OF GREEK TEXTS The Biographies INTRODUCTION TO PLUTARCH by Bernadotte Perrin LIFE OF PLUTARCH by Aubrey Stewart Please visit www.delphiclassics.com to browse through our range of exciting titles