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

by Miller, MD, Henry I.

• ISBN13: 9780817999025
• ISBN10: 0817999027
• Format: Paperback
• Copyright: 2000-08-01
• Publisher: Hoover Institution Press

Summary

A government monopoly over drug regulation is not sacrosanct. In fact, federal oversight-which vitally affects the availability of drugs to patients in need-is in shambles. The regulatory monopoly of the federal Food and Drug Administration has become, literally, overkill and actually threatens public health. Regulatory reform that introduces competition and incentives to get safe, effective drugs to patients can, however, transform the drug development process and reverse the current upward spiral of time and costs. The public will benefit directly by earlier access to greater numbers of less costly drugs and indirectly by greater robustness and productivity in the pharmaceutical industry.

Author Biography

Dr. Henry I. Miller -- physician, molecular biologist, public policy analyst, and former federal regulator -- is a senior research fellow at the Hoover Institution at Stanford University

Table of Contents

List of Figures	ix
Foreword	xi
Terry L. Anderson
Preface	xvii
John J. Cohrssen
Acknowledgments	xxiii
Introduction	1	(10)
PART I THE NEED FOR FUNDAMENTAL FOOD AND DRUG ADMINISTRATION REFORM
The Birth and Growth of Premarket Regulation	11	(8)
Factors Affecting Drug Development	19	(16)
Reforming the Current System	35	(14)
The Failure of Self-Reform and Congressional Reform	49	(22)
PART II A MODEL FOR REFORM OF THE FOOD AND DRUG ADMINISTRATION
A Spectrum of Possibilities	71	(12)
A Proposal for Regulatory Reform	83	(24)
Summary	105	(2)
Index	107