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 Two

THE HISTORY OF THE INTERIM RULE

The history of the Interim Rule involves the discussions that led to its promulgation ; the immediate, but limited, controversy surrounding it; and the FDA decision seven years after the Gulf War to complete the rule-making process. The brief text of the Interim Rule was provided at the end of Chapter One. Its main provisions are these: A process is established by which a determination may be made by the Commissioner of Food and Drugs, pursuant to a written request by the Assistant Secretary of Defense (Health Affairs) (ASD[HA]), that obtaining informed consent for the use of investigational drugs is "not feasible" for a "specific military operation involving combat or the immediate threat of combat." The request must indicate that a duly constituted IRB has reviewed and approved the use of the IND without informed consent. The commissioner, in reaching his or her decision, may find that obtaining informed consent is not feasible "only when withholding treatment would be contrary to the best interests of the military personnel" and when "no available satisfactory alternative therapy" is available.


THE MEMORANDUM OF UNDERSTANDING BETWEEN DOD AND
FDA

A Memorandum of Understanding (MOU) has existed between DoD and FDA for some time that pertains to the "investigational use of drugs, antibiotics, biologics, and medical devices" by DoD (52 FR 33472, September 3, 1987). 1 It provides that clinical testing of investigational drugs, biologics, or medical devices under programs sponsored by DoD, whether conducted within DoD facilities or by a contractor or grantee, will follow FDA regulations governing

____________________
1
Initially executed by the Department of Health, Education, and Welfare and DoD in 1964, the MOU was revised in 1974 to indicate the procedures that would be followed "to ensure that the requirements of the Federal Food, Drug, and Cosmetic Act and its implementing regulations are fully met without jeopardizing or impeding the requirements of national security." It was revised again in 1987, and it is this version that is currently in force.

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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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