This report examines the regulatory issues associated with the use of drugs not yet approved by the Federal Food and Drug Administration (FDA) for the defense of military forces against chemical and biological warfare agents. It uses the 1991 Gulf War as the point of departure but deals with the issues in the context of contemporary FDA policymaking.
The purposes of this report are (1) to examine historically the adoption in 1990, in the shadow of the impending Gulf War, of the Interim Rule (55 FR 52814,
December 21, 1990), which 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; and the subsequent controversy surrounding the rule, its application, and its implications; (2) to analyze the issues the Interim Rule raised when investigational drugs are used for such purposes; and (3) to make recommendations.
Chapter Two examines the historical development of the Interim Rule. Chapter Three addresses the definitional issues surrounding investigational. In Chapter Four, the Interim Rule and its alternatives are considered. Chapter Five discusses several broader issues than the immediate regulatory questions the
Interim Rule itself raised. Finally, in Chapter Six, conclusions are drawn and recommendations are made.
Iraq invaded Kuwait on August 2, 1990. In response, the U. S. government demanded its withdrawal, deployed over half a million military personnel to Saudi Arabia (Operation Desert Shield) to deter further Iraqi aggression against neighboring states, and initiated a United Nations debate that called for Iraq's withdrawal by January 15. When Iraq ignored this deadline, coalition forces, led