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

PREFACE

This report is one of several commissioned by the Special Assistant to the Deputy Secretary of Defense for Gulf War Illnesses. It deals with the Interim Rule, adopted in December 1990, which established the authority of the Commissioner of Food and Drugs to waive informed consent for using investigational drugs in certain military contingencies. The contingency for which it was adopted and in which it was used was the 1991 Gulf War, when U. S. and coalition forces confronted the possibility of chemical and biological weapons being used by the Iraqi military. The investigational drugs in question were pyridostigmine bromide and botulinum toxoid vaccine.

In mid-1997, when the research on which this report is based was completed, the rule making initiated by the Interim Rule had not been completed. Rule making resumed, however, with the issuance on July 31, 1997 of a "Request for Comments" by the Food and Drug Administration (FDA) (62 Federal Register 40996), "Accessibility to New Drugs for Use in Military and Civilian Exigencies When Traditional Human Efficacy Studies are Not Feasible; Determination Under the Interim Rule That Informed Consent Is Not Feasible for Military Exigencies." This request asked for public comment on the merits of issuing an unchanged Interim Rule as a final rule, modifying the current rule, or revoking it entirely. Although comments were received in response to this FDA request, rule making had not been completed by summer 1998. However, by mid‐ October, Congress resolved the issue with the enactment of Sec. 731 of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 (Public Law 105-261, October 17, 1998). This statutory enactment vested the authority to grant waivers, initially authorized by the Interim Rule, solely in the President of the United States. A brief postscript at the end of this report summarizes these developments.

This long lapse of time between the adoption of the Interim Rule and the statutory resolution of policy issues raised by it reflects both the low frequency with which the threat of chemical and biological weapons arises and the complexity of the issues raised by the rule. Regarding the frequency, Judge Ruth

-v-

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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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