August 2, 2005 - ASM Comments on NIH Reauthorization Bill

The Honorable Joe Barton, Chairman
Committee on Energy and Commerce
United States House of Representatives
Washington, DC 20515

Dear Representative Barton:

The American Society for Microbiology (ASM), the largest single life science society with over 42,000 members, welcomes the opportunity to comment on the draft legislation to amend title IV of the Public Health Service Act to revise and extend the authorities of the National Institutes of Health (NIH). The ASM appreciates Congress’s strong support for the NIH as the leader of the nation’s biomedical research enterprise. In general, the role of Congress has been one of oversight and appropriation, which has benefited NIH and provided a climate of flexibility without inappropriate political control over scientific decision making. The NIH has been able to respond to changes and opportunities in research which has led to enormous scientific progress against disease and disability. We urge that this approach be continued to maximize the nation’s investment in health related research.

The ASM wishes to emphasize the importance of Congressional support for NIH to ensure its continued success as the world leader in sponsoring biomedical research and responding to present and future health challenges. These challenges remain daunting, as emerging and still incurable diseases threaten millions of people and strategies for prevention, treatment and care remain to be addressed.

The significant number of new discoveries resulting from NIH supported research attest to the effective way in which the NIH and the respective institutes have carried out the mission of NIH to pursue scientific knowledge to improve human health. In general, NIH reauthorization legislation should recognize that it is critical that scientific directions and research priorities be identified at the Institute level to ensure the best and most appropriate scientific expertise is brought to bear on decisions concerning strategies to exploit research opportunities, to assess the implications of new molecular analytic tools and to evaluate major changes in science and public health needs in relationship to resource allocations. By balancing unsolicited meritorious research grants with special initiatives, NIH responds to urgent public health needs, emerging scientific opportunities and gaps in scientific knowledge.

The NIH institutes have developed decision making processes for planning and priority setting that incorporate input from a variety of sources, including the scientific community, patient groups, the pharmaceutical industry, other federal agencies involved in research and public health, the Administration, Congress, and others. The national advisory councils of the individual institutes and other standing and ad hoc advisory bodies include scientific and lay advisors who are able to interact with the institutes in the process of shaping the priorities and direction of research. The NIH Director works together with the leadership of the institutes and centers on the best strategic mechanisms for achieving the mission and goals of NIH. The NIH peer review system is pivotal to translating scientific direction into medical progress.

Revisions in the NIH organization and management must be done carefully to avoid disturbing judicious planning processes and the role of institutes in providing the structure and expertise needed to implement the mission and goals of NIH.

As the House Committee on Energy and Commerce moves forward with NIH reauthorization, we would like to submit the following comments for the Committee’s review and consideration.

1) Authorization of funding: NIH reauthorization legislation should authorize adequate funding levels to ensure that funding builds on the momentum of successes of the NIH and biomedical research. Following the doubling of the NIH budget between l999 and 2003, the NIH budget has flattened. At less than 1 percent, the proposed FY 2006 budget increase for NIH would result in difficult funding decisions for biomedical research programs. The FY 2006 budget request for NIH falls below the current biomedical rate of inflation, which is 3.5 percent. This static state in funding comes at a time of unprecedented opportunities for major advances in human health and also at a time when the nation’s competitors are increasing investments in research. Increased investment in research in the United States is essential to the growth of US technology as well as medical progress.

2) New funding structure: The legislation modifies the way in which NIH programs are authorized and appropriated. The discussion draft creates four appropriations categories and clusters the 24 NIH institutes and centers into two major divisions with mission specific and science enabling responsibilities. This change in policy would authorize broad levels of funding for four divisions, changing the current process by which appropriations are allocated through line items along institute and center designations. Dividing the institutes into mission and science enabling categories is not appropriate since each has a mandate with defined priorities that address science and health matters from a specific perspective. The purpose of the new funding structure and how consolidating funding for the institutes and centers into four divisions will affect budget decisions is unclear. It is not obvious how this change will affect the institutes and centers, how funds would be divided among the institutes and centers and how the funding baselines for each institute and center would be determined each year. The justification for or benefit of this new budget alignment is not apparent.

3) Transfer authorities: The discussion draft provides new authorities to the NIH Director, including identifying research important to the advancement of biomedical science and involving the responsibilities of more than one institute or center. The Director is empowered with the same grant making authorities that currently reside at the institute level to conduct trans-NIH research activities, subject to advisory council approval. A trans-agency fund would give the NIH Director authority to allocate an undetermined percentage of the NIH appropriation, from statutorily required contributions by institutes and centers to support new and strategic research opportunities. We support the goal to increase the role of the NIH Director in facilitating processes to coordinate across the institutes when it is beneficial to scientific progress and public health needs, as well as enhancing the authority of the Director to oversee the NIH research portfolio.

While we agree that the NIH Director should have transfer authority, which is currently set at 1 percent of the NIH budget, increasing the authority to reallocate funds from the institutes and centers and raising the amount of this pool of funds to an unspecified level which can be redirected from the institutes raises a number of issues which could represent a potential risk to science and the established framework of advisory and scientific program decision making at the institute level. It is unclear how much funding would be reallocated and the process and accountability for expenditure of these funds based on research opportunities, public health needs and priorities. A ceiling should be established for such transfers. The draft legislation does not specify how the Director would use the grant making authorities. It is unclear how the advisory council and the planning process will work for identifying major new trans-NIH research projects and the needs and high priority new initiatives that no single institute can address alone. It will be necessary to obtain the relevant scientific and public health input to achieve consensus on crosscutting priorities and initiatives.

4) Division of program coordination, planning and strategic initiatives: The legislation establishes within the Office of the Director a Division of Program Coordination, Planning and Strategic Initiatives which would have its own authorized level of funding and authority to conduct and support research. There is little to guide the scientific community in knowing how this Division would function and how resources under the control of the Division would be managed and spent. Facilitating processes to increase coordination and synergy across the institutes is a worthy objective. However, the amount of resources that would be allocated to the Division, the interaction of the proposed Division with the institutes and centers, and the scope of its authority and competence to make grants as a centralized Division within NIH are issues of concern.

5) Reorganization authority: The discussion draft authorizes the Director of NIH to reorganize the ICs subject to three requirements: approval of the Secretary of HHS, a public process carried out by regulation and notice to Congress. In addition to the public process, we recommend that an external committee of scientific experts or the Institute of Medicine carefully assess proposed changes to the NIH institute and center structure.

The ASM appreciates the opportunity to comment on the proposed reauthorization bill for the NIH and we look forward to working with Congress on ways to strengthen biomedical research and the NIH.

Sincerely,

Ruth L. Berkelman, M.D., Chair, Public and Scientific Affairs Board
Gail H. Cassell, Ph.D., Chair, Committee on Biomedical Research

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