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 Bader Ginsburg, then the circuit court judge for the U.S. Court of Appeals for the District of Columbia Circuit, wrote in 1991 that the likelihood of U.S. military personnel encountering chemical and biological warfare threats in the future fell "in the middle ground between cases in which the recurrence prospect is nonexistent or extremely remote, and those in which the probability of repetition is extremely high."[1] Such uncertain threats with potentially disastrous consequences pose difficult challenges for both military and civilian policymakers. This report attempts to contribute to the understanding of the complexity of the issues surrounding the Interim Rule and to an understanding of the controversy that was only recently resolved.
The other RAND reports are reviews of the scientific literature on the health effects of chemical and biological agents, pyridostigmine bromide, oil fire pollution, depleted uranium, pesticides, infectious diseases, immunizations, and stress.
This work is sponsored by the Office of the Special Assistant and was carried out jointly by RAND Health's Center for Military Health Policy Research and the Forces and Resources Policy Center of the National Defense Research Institute. The latter is a federally funded research and development center sponsored by the Office of the Secretary of Defense, the Joint Staff, the unified commands and the defense agencies.
The audiences for whom this paper is intended include the civilian and military officials responsible for doctrine, policy, and systems related to the deployment of troops to theaters of operation where the threat of attack with chemical and biological weapons is a real possibility, including those responsible for the protection of the health and fitness of U.S. military personnel and for the conduct of supporting medical research and drug development. Another audience is the civilian officials responsible for administering the laws and regulations governing the review and approval of drugs and vaccines for military use, including those officials with specific responsibilities for the protection of human subjects of research. Finally, a critical audience is the American public concerned that its public policies regarding the protection and treatment of U.S. military personnel deployed to hostile environments in which they face the threat of chemical or biological weapons are simultaneously pragmatic and ethical.