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STATUS OF THE COMMITTEEâS INVESTIGATIONS 3 Improving Vaccine Acquisition and Availability in the U.S. Military (IOM, 2002), which was released in September 2002, was prepared by an IOM committee that was convened in April 2000 to advise the U.S. Army Medical Research and Materiel Command on the acquisition process for vaccines to protect against naturally occurring disease threats. STATUS OF THE COMMITTEEâS INVESTIGATIONS The committee reports that at this time its investigations are not yet complete and do not provide an adequate basis for developing any findings or recommendations. The issue before the committeeâaccelerating research, development, and acquisition of safe and efficacious medical countermeasures against biowarfare agentsâis complex and requires careful consideration of many different matters, including the organization and management of activities in multiple components of DoD; regulatory policies and procedures involving FDA; the state of the science related to biowarfare agents and the development of drugs, vaccines, and other prophylactic or therapeutic products to be used against those agents; and the availability of financial and other resources to support the acquisition process. Moreover, the committee requires sufficient time to learn more about and assess the implications of recent and important changes that are reshaping the environment in which DoDâs acquisition of medical countermeasures occurs. Funding for DoDâs research and development for medical countermeasures has increased over the past 3 years (DoD, 2003), and DoD has reorganized various aspects of its Chemical and Biological Defense Program, including changes ordered within the past 6 months (Aldridge, 2002). DoDâs work is directed primarily at protection of U.S. military forces on the battlefield, but it cannot be examined in isolation from new activities that focus on domestic concerns for protection against bioterrorism. These new activities include: proposals for substantial new funding for biodefense research and development for NIAID for fiscal years 2003 and 2004; official establishment of the Department of Homeland Security in January 2003; and announcement in January 2003 in the State of the Union Address of Project BioShield, a proposed initiative aimed at ensuring the availability of modern drugs and vaccines to protect against chemical and biological threats (White House, 2003). Also relevant to the committeeâs task is consideration of a new FDA rule (FDA, 2002) that as of July 2002 permits the submission of animal data to demonstrate the efficacy of new drugs and biological products when human efficacy studies are not ethical or feasible. The committee must consider as well interim regulations that are to take effect in February 2003 and will impose stricter security procedures for research in academia and the private sector involving certain pathogens and toxins (i.e., select agents) (DHHS, 2002). After it has completed its review and deliberations involving these and other matters, the committee looks forward to providing in its final report constructive findings and recommendations regarding accelerating DoDâs acquisition of medical countermeasures against biowarfare agents.
