November 4, 2005 - ASM Comments on the Biodefense and Pandemic Vaccine and Drug Development Act of 2005

The Honorable Richard Burr
Chair, Subcommittee on Bioterrorism and Public Health Preparedness
Committee on Health, Education, Labor and Pensions
424 Dirksen Senate Office Building
Washington, DC 20510-6307

Dear Senator Burr:

The American Society for Microbiology (ASM), the largest life science society with a membership of over 42,000, is writing to comment on Section 3, the Biomedical Advanced Research and Development Agency (BARDA), in the Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (S.1873). ASM members are involved in research and public health efforts aimed at eradicating the scourge of infectious diseases. In responding to the threat of biological agents, the United States needs to ensure that we have the vaccines, pharmaceuticals and diagnostics to protect the public health from naturally occurring infectious diseases as well as bioterrorism. Combating infectious diseases and increasing medical preparedness against pandemic infections and bioterrorism necessitates increasing biomedical and other life science research.

The ASM concurs that efforts are needed to speed the development of new products and research tools to protect against terrorism and pandemic diseases and is grateful for the support that Congress has provided for the Department of Health and Human Services (DHHS), including the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). Since September 11, 2001, significant progress has been made through the enactment of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project Bioshield Act of 2004. The public health infrastructure has been strengthened at the state and federal levels. The National Institute of Allergy and Infectious Diseases (NIAID), the lead agency at NIH for infectious diseases and immunology research which is responsible for implementation of the strategic plan for biodefense research, has put in place over 60 biodefense initiatives. The DHHS has created a top level Office of Public Health Emergency Preparedness (OPHEP) to coordinate department activities. However, it is apparent that deficiencies and gaps remain, particularly related to policies and resources for late stage product development and the implementation of Project Bioshield.

It is our understanding that S.1873 is intended to build on Project Bioshield by removing barriers and creating incentives to encourage countermeasure development for medicines and diagnostics for infectious diseases. The ASM is concerned, however, about the proposal for the creation of a new and additional agency, i.e. BARDA; it does not appear to be the best solution. Alternatively, we recommend that OPHEP be given authorities outlined in S. 1873 and the resources necessary to effectively expedite and oversee late stage product development.

While ASM agrees with the needs outlined for establishment of the National Biodefense Advisory Board, working groups, and the flexibility required to rapidly access individuals with special areas of expertise, we are concerned that these activities could be conducted outside the requirements set forth in the Federal Advisory Committee Act (FACA) and Freedom of Information Act (FOIA) exceptions, which raises concerns about transparency and infectious diseases. Information should be subject to disclosure unless the HHS determines that disclosure would pose a threat to national security, rather than making nondisclosure the default mode. A decision of HHS to withhold documents should be subject to judicial review.

The roles of the OPHEP and other agencies in early and late stage product development should be more clearly delineated. An external review by an independent body such as the Institute of Medicine of the National Academy of Sciences would be useful in this regard and would also help to identify existing gaps, inefficiencies, and duplication of efforts as the processes currently exist. The ASM understands the need for oversight and coordination, but for the nation to derive the full benefit of its research programs, it cannot afford to dilute existing and planned scientific research or confuse and duplicate research initiatives.

Finally, language in the bill is unclear about the source and amount of funding for the proposed BARDA. The extent to which the existing budget of HHS for research on existing and emerging infectious diseases would be affected is uncertain. While adequate funding for OPHEP and oversight of late stage product development is critical, funding of activities authorized in S. 1873 should not be at the expense of research that is the essential underpinning for the development of countermeasures.

The ASM appreciates the opportunity to comment on S. 1873 and looks forward to working with you to assess the most efficient and effective system for responding to threats from infectious diseases.

Sincerely,

Stanley Maloy, Ph.D., President, ASM

cc: 

The Honorable Joe Barton, Chair of the House Committee on Energy and Commerce
The Honorable John Dingell, Ranking Minority Member of the House Committee on Energy and Commerce

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