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.
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: