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

Chapter Six

CONCLUSIONS AND RECOMMENDATIONS

On the basis of the foregoing analysis, we reached the following conclusions about the policy governing the use of investigational drugs by DoD for certain military combat exigencies. First, although policymaking in the shadow of war may involve careful deliberation, as occurred in the months preceding the Gulf War, it is better to have an adequate policy in place beforehand, broad enough to respond to a number of contingencies and yet narrow enough to avoid abuse or confusion.

Second, as preliminary orienting assumptions to the regulatory regime, it is important to recognize that the threat of CW/BW agents being used against U. S. military forces has permanently altered the context in which the use of investigational drugs is being considered. In addition, notwithstanding many similarities, there are important differences between military drug development and commercial drug development for a civilian market.

Third, a rule authorizing the Commissioner of FDA to waive informed consent for the use of investigational drugs in certain military situations is needed. The Interim Rule provided an adequate policy in the Gulf War, notwithstanding major problems in its implementation. A modification of this rule is likely to result from the completion of rule making. However, complete revocation of the existing rule could be potentially very dangerous in operational terms if it limited DoD's ability to respond to CW/BW threats.

Fourth, investigational is a term without precise meaning. It does not demarcate the boundary between research and treatment with a bright orange line. Rather, it constitutes a gray zone in which most of the activity is research, much of the activity involves both research and treatment, and some activity is solely treatment.

Fifth, the most sensible modifications of the current Interim Rule would involve briefly indicating the general requirements for the provision of information to military personnel, training of medics and others responsible for administration of vaccines, training of commanders responsible for ordering self‐

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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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