Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense: Lessons from the Gulf War

By Richard A. Rettig | Go to book overview
CONTENTS
Preface v
Figure and Tables ix
Summary xi
Acknowledgments xvii
Glossary xix
Chapter One
INTRODUCTION 1
Purpose and Organization 1
Background 1
TheIraqiThreat 1
The Regulatory Regime 3
The Drugs in Question 5
The Response to the Iraqi Threat 7
The Issues 10
The Text of the Interim Rule 11
Chapter Two
THE HISTORY OF THE INTERIM RULE 13
The Memorandum of Understanding Between DoD and FDA 13
Careful Deliberations: 1990 15
DoD-FDA Discussions 15
DoD Requests Authorization to Waive Informed Consent 23
FDA Rule Making 25
Request for Waivers 26
Litigation: 1991 28
John Doe and Mary Doe v. Louis Sullivan and Richard Cheney, USDC, District of Columbia, 756F. Supp. 12, January 31, 1991 28
Doe v. Sullivan, 938 F.2d 1370, No. 91-5019, USApp DC 111, heard March 18, 1991, decided July 16, 1991 30

-vii-

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Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense: Lessons from the Gulf War
Table of contents

Table of contents

  • Military Use of Drugs Not Yet Approved by the Fda for Cw/Bw Defense *
  • Preface v
  • Contents vii
  • Figure and Tables ix
  • Summary xi
  • Acknowledgments xvii
  • Glossary xix
  • Chapter One - Introduction 1
  • Chapter Two - The History of the Interim Rule 13
  • Chapter Three - What Uses of Drugs Are Investigational? 41
  • Chapter Four - The Interim Rule and Its Alternatives 59
  • Chapter Five - Broader Issues 81
  • Chapter Six - Conclusions and Recommendations 95
  • Chapter Seven - Postscript 97
  • References 99
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