Overview

In the last quarter of the 20th century, politicians in Washington, as well as interest groups, regulatory policy makers, and drug industry leaders were forced to confront the hot-button issue of pharmaceutical regulation. The struggle always centered on product innovation, consumer protection, and choice in the free market. As the American economy stuttered in the late 1970s, the stakes were extremely high for the powerful drug industry and the American public. At the center of this drama was the Food and Drug Administration, which was censured from both the left and right of the political spectrum for being too strict and too lenient in the application of its regulatory powers. Lucas Richert explores the FDA, drugs, and politics in the context of the watershed Reagan era, a period when the rhetoric of limited government, reduced regulation, and enhanced cooperation between businesses and U.S. regulatory agencies was on the ascent. As he investigates the controversies surrounding Laetrile, Reye’s Syndrome, Oraflex, patient package inserts, diet pills, and HIV/AIDS drugs, Richert argues that the practical application of conservative economic principles to the American drug industry was A Prescription for Scandal.

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9780739194645

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Reviews

Lucas Richert's book ably reviews the place of the FDA in the modern regulatory order, and helps make the agency's struggles comprehensible. Richert shows that our system of drug approval and regulation cannot be understood in simple back-and-white terms. Instead, a host of competing interests pull the FDA in all sorts of directions. Anyone interested in contemporary drug regulation will find this a useful resource. -- Joseph F. Spillane, University of Florida Conservatives, Consumer Choice, and the FDA in the Reagan Era is an engaging analysis of the influence of presidential ideology, congressional oversight, and the political character of the FDA's leadership on the agency's institutional identity and regulatory work. Lucas Richert's compelling and nuanced perspective exposes the limits of the deregulatory ethos of the Reagan era and demonstrates the persistence of an institutional identity that has balanced the imperatives of consumer safety against those of pharmaceutical innovation. This book is a must-read for anyone interested in the recent history of pharmaceutical regulation and for policymakers engaged in the making of pharmaceutical policy. -- Dominique Tobbell, University of Minnesota A thoughtful and accessible narrative history that situates the FDA in the partisan and ideological politics of the long Reagan era. -- David Herzberg, University at Buffalo, State University of New York

Lucas Richert's book ably reviews the place of the FDA in the modern regulatory order, and helps make the agency's struggles comprehensible. Richert shows that our system of drug approval and regulation cannot be understood in simple back-and-white terms. Instead, a host of competing interests pull the FDA in all sorts of directions. Anyone interested in contemporary drug regulation will find this a useful resource. -- Joseph F. Spillane, University of Florida Conservatives, Consumer Choice, and the FDA in the Reagan Era is an engaging analysis of the influence of presidential ideology, congressional oversight, and the political character of the FDA's leadership on the agency's institutional identity and regulatory work. Lucas Richert's compelling and nuanced perspective exposes the limits of the deregulatory ethos of the Reagan era and demonstrates the persistence of an institutional identity that has balanced the imperatives of consumer safety against those of pharmaceutical innovation. This book is a must-read for anyone interested in the recent history of pharmaceutical regulation and for policymakers engaged in the making of pharmaceutical policy. -- Dominique Tobbell, University of Minnesota A thoughtful and accessible narrative history that situates the FDA in the partisan and ideological politics of the long Reagan era. -- David Herzberg, University at Buffalo, State University of New York The effect of presidential and interest-group politics on public agencies has been a fundamental problem in public administration for more than a century. This new book, a case study of the Food and Drug Administration during the 1980s, is an effort to show how President Ronald Reagan's budget and regulatory policies impacted the FDA's effectiveness in protecting the public and in supporting the creation of new pharmaceuticals. This period was also the time of the beginning of the HIV/AIDS pandemic and the rapid growth of generic drugs. Richert suggests that many of the FDA's difficulties in the 1980s and beyond can be traced to the Reagan administration's budget cutting, Congress's expansion of the agency's range of responsibilities, and political pressures from HIV/AIDS advocates and makers of generic drugs. He based his analysis on a wide range of secondary sources, along with official documents from the FDA and elected officials. Readers will reach different conclusions regarding the book's success in establishing the causal connections between Reaganism and the FDA's problems, but the book makes a strong case that the FDA does not operate in a political vacuum. Summing Up: Recommended. Lower-division undergraduate collections and above. * CHOICE * This book is a contribution to a growing body of scholarship on the history of the US Food and Drug Administration (FDA). . . . The book tells an interesting part of the FDA story in the 1980s that can be put into longer historical perspective. * Social History Of Medicine *

Author Information

Lucas Richert is a postdoctoral fellow at the University of Saskatchewan.

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