Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents: Interim Report (2003)

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STUDY COMMITTEE AND STUDY CHARGE 1 Accelerating the Research, Development, and Acquisition ofMedical Countermeasures AgainstBiological Warfare Agents Interim Report INTRODUCTION Having the means to protect its military personnel against biological warfare agents is a long-standing objective for the United States. The development of safe and effective medical countermeasures—vaccines, antitoxins, and prophylactic and therapeutic drugs—against those agents is one of the essential components of the nation’s biological defense efforts. The nation’s experience in the fall of 2001 with civilian infections and five deaths following exposure to anthrax spores sent through the U.S. postal system reinforced the seriousness of the threat posed by biological warfare agents and the need for medical countermeasures against them. Currently, the United States has a limited repertoire of licensed medical countermeasures that the Department of Defense (DoD) can use to protect members of the armed forces against more than a dozen bacteria, viruses, and toxins identified as possible biological warfare agents. As part of its Chemical and Biological Defense Program, DoD is engaged in research and development efforts aimed at making available a broader range of medical countermeasures. In the National Defense Authorization Act for fiscal year 2002,1 Congress directed the Secretary of Defense to accelerate these efforts. In addition, the Secretary was directed to contract with the Institute of Medicine (IOM) and the National Research Council (NRC) for a study of the review and approval process for new medical countermeasures in order to identify new approaches to accelerate that process and to identify methods for assuring that new countermeasures will be safe and effective. This document is an interim report on the IOM/NRC study, as required under the contract with DoD. STUDY COMMITTEE AND STUDY CHARGE To carry out the congressionally mandated study, IOM and NRC convened the Committee on Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents. The members of the committee bring to the study expertise in drug and vaccine acquisition in DoD; vaccine and drug research, 1National Defense Authorization Act for Fiscal Year 2002, P.L. 107–107 (2001); National Defense Authorization Act for Fiscal Year 2002, Conference Report to Accompany S. 1438, House Rpt. 107–333 (2001).