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The confrontation that began when Iraq invaded Kuwait in August 1990 brought with it the threat that chemical and biological weapons might be used against the more than half a million military personnel the United States deployed to the region. To protect these troops from such threats, the Department of Defense wished to use drugs and vaccines that, not having been tested for use in these specific situations, were considered “investigational” by the federal Food and Drug Administration. This report examines the history of the Interim Rule, adopted in December 21, 1990, that authorized the Commissioner of Food and Drugs to waive informed consent for the use of investigational drugs and vaccines for certain military uses; how this authority was used for pyridostigmine bromide and botulinum toxoid during the Gulf War; and the subsequent controversy surrounding the rule, its application, and its implications. The report then analyzes the issues the Interim Rule raised when investigational drugs are used for such purposes and makes recommendations for dealing with similar situations in the future.

Table of Contents

  • Chapter One

    Introduction

  • Chapter Two

    The History of the Interim Rule

  • Chapter Three

    What Uses of Drugs Are Investigational?

  • Chapter Four

    The Interim Rule and Its Alternatives

  • Chapter Five

    Broader Issues

  • Chapter Six

    Conclusions and Recommendations

  • Chapter Seven

    Postscript

This research was sponsored by the RAND National Security Research Division and RAND Health.

This report is part of the RAND Corporation monograph report series. The monograph/report was a product of the RAND Corporation from 1993 to 2003. RAND monograph/reports presented major research findings that addressed the challenges facing the public and private sectors. They included executive summaries, technical documentation, and synthesis pieces.

The RAND Corporation is a nonprofit institution that helps improve policy and decisionmaking through research and analysis. RAND's publications do not necessarily reflect the opinions of its research clients and sponsors.