Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological 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,

1  

National 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).



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Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents: Interim Report Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological 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, 1   National 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).

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Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents: Interim Report development, testing, and evaluation in academia and the pharmaceutical and biotechnology industries; animal laboratory science; federal drug and vaccine regulatory policy; legal and economic issues in drug and vaccine development; and management processes in government and industry. The committee has the following charge: The committee will examine DoD’s biowarfare countermeasure drug and vaccine acquisition process. The acquisition process includes the early science and technology development (research and development program elements 6.1, 6.2, 6.3) and advanced development (program elements 6.4, 6.5) through the approval and licensure of products. The study will not examine production and procurement processes. The committee will identify factors that are impeding or slowing the acquisition processes and will recommend strategies or options for accelerating these processes. The medical products covered by the study include vaccines, antitoxins, chemoprophylactics, and chemotherapeutics. The committee is not examining acquisition of diagnostic products or other biodefense products, such as protective suits, decontamination equipment, or sensors for detection of biological agents, that are also being developed as part of DoD’s Chemical and Biological Defense Program. The contract calls for the submission of this interim report by March 31, 2003, and the final report by December 31, 2003. STUDY PROCESS The committee plans to gather information for this study through a series of public meetings, through a review of related reports to Congress and DoD, and through a review of other information related to the study task. At the time this interim report was prepared, the committee had held two public meetings, in December 2002 and January 2003 (see Appendix A for meeting agendas). These meetings focused on discussions of the origins of the study and the organization and management of DoD’s research and development for medical countermeasures against biowarfare agents, as well as an overview of the role of the Food and Drug Administration (FDA) in the licensure of drugs and vaccines and other biological products. The committee heard formal presentations from invited participants and had an opportunity to ask them questions and engage in less structured discussions. The committee expects to hold additional public meetings for information gathering in March, April, and June 2003. A closed meeting devoted to committee deliberations is also planned. At the upcoming public meetings, the committee expects to hear again from representatives from DoD and in more detail from representatives from FDA. The committee will also hear from others with relevant responsibilities and expertise, such as representatives from the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health, the Department of Homeland Security, the pharmaceutical and biotechnology industries, and the academic research community. The findings and recommendations from two previous reports on related matters were also reviewed with the committee at its first meeting. A report on DoD’s acquisition of vaccine production (Top et al., 2000), commissioned by the Deputy Secretary of Defense in July 2000, was prepared by a panel of experts chaired by Franklin Top, Jr. Their report was submitted to DoD in late 2000 and publicly released in July 2001. The second report, Protecting Our Forces:

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Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents: Interim Report 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 COMMITTEE’S 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 committee—accelerating research, development, and acquisition of safe and efficacious medical countermeasures against biowarfare agents—is 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 DoD’s acquisition of medical countermeasures occurs. Funding for DoD’s 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). DoD’s 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 committee’s 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 DoD’s acquisition of medical countermeasures against biowarfare agents.

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Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents: Interim Report REFERENCES Aldridge EC Jr. 2002. Acquisition decision memorandum—management of the Chemical/Biological Defense Program. Memorandum for Secretary of the Army. Department of Defense, Washington, D.C., September 19. DHHS (Department of Health and Human Services). 2002. Possession, use, and transfer of select agents and toxins; interim final rule. Federal Register 67(240):76885–76905. DoD (Department of Defense). 2003. DoD medical biological defense research funding. Information provided by the Chemical and Biological Defense Program to the Institute of Medicine/National Research Council Committee on Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents. Washington, D.C. FDA (Food and Drug Administration). 2002. New drug and biological drug products; evidence needed to demonstrate effectiveness of new drugs when human efficacy studies are not ethical or feasible. Federal Register 67(105):37988–37998. IOM (Institute of Medicine). 2002. Protecting Our Forces: Improving Vaccine Acquisition and Availability in the U.S. Military. Lemon SM, Thaul S, Fisseha S, O’Maonaigh H, eds. Washington, D.C.: National Academies Press. Top FH Jr., Dingerdissen JJ, Habig WH, Quinnan GV Jr., Wells RL. 2000. DoD Acquisition of Vaccine Production: Report to the Deputy Secretary of Defense by the Independent Panel of Experts. In DoD, 2001. Report on Biological Warfare Defense Vaccine Research and Development Programs. Washington, D.C.: Department of Defense. White House. 2003. President details Project BioShield. Washington, D.C., February 3. [Online] Available: http://www.whitehouse.gov/news/releases/2003/02/print/20030203.html [accessed February 5, 2003].