To America's Health: A Proposal to Reform the Food and Drug Administration

Overview

A government monopoly over drug regulation is not sacrosanct. This hard-hitting book describes the current regulation of drugs by the FDA and proposes a model for fundamental, yet workable, reform—including an innovative proposal for drug testing and certification review.
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Overview

A government monopoly over drug regulation is not sacrosanct. This hard-hitting book describes the current regulation of drugs by the FDA and proposes a model for fundamental, yet workable, reform—including an innovative proposal for drug testing and certification review.
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Editorial Reviews

From the Publisher

"Extraordinary for its depth, documentation, and originality. In terms of analyzing the current system of drug regulation, making the case for reform, and proposing a remedy, this volume simply dwarfs everything else available on the subject. Most important of all, it really does move us along the path 'To America's Health!'"

- Michael H. Mellon, M.D., Associate Clinical Professor, Pediatrics, University of California, San Diego, School of Medicine, La Jolla, CA

Booknews
The Food and Drug Administration (FDA) is the national gatekeeper for the introduction of new drugs into US markets. The author, a senior research fellow at the Hoover Institution at Stanford University, argues that the FDA's monopoly over drug regulation actually threatens public health, and recommends regulatory reform that introduces competition and incentives to get safe, effective drugs to patients. Annotation c. Book News, Inc., Portland, OR (booknews.com)
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Product Details

  • ISBN-13: 9780817999025
  • Publisher: Hoover Institution Press
  • Publication date: 10/1/2000
  • Series: Publication Series
  • Pages: 112
  • Product dimensions: 6.05 (w) x 9.04 (h) x 0.36 (d)

Meet the Author

Henry I. Miller, M.S., M.D., is a research fellow at the Hoover Institution. His research focuses on public policy toward science and technology, especially pharmaceutical development and the new biotechnology. His work often emphasizes the excessive costs of government regulation and models for regulatory reform.

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Table of Contents

List of Figures
Foreword
Preface
Acknowledgments
Introduction 1
Pt. I The Need for Fundamental Food and Drug Administration Reform
1 The Birth and Growth of Premarket Regulation 11
2 Factors Affecting Drug Development 19
3 Reforming the Current System 35
4 The Failure of Self-Reform and Congressional Reform 49
Pt. II A Model for Reform of the Food and Drug Administration
5 A Spectrum of Possibilities 71
6 A Proposal for Regulatory Reform 83
Summary 105
Index 107
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