House NIH Reauthorization Bill on Hold Until Late October

September 15, 2005—The House Energy and Commerce Committee’s draft legislation to reauthorize the National Institutes of Health (NIH) has been put off until at least late October while the Committee focuses on more pressing issues related to rising fuel prices and cutting $10 billion from Medicaid.

Congress last reauthorized NIH in 1993. Energy and Commerce Committee Chairman Joe Barton (R-TX) made reauthorizing NIH one of his priorities after taking over as chairman of the committee in 2004.

Background on Draft NIH Reauthorization Bill
On August 22, the Energy and Commerce Committee released a second draft of the legislation to reauthorize NIH.

Overall, the draft bill focuses the organization and function of the Office of the Director of NIH and its relationship to the individual NIH institutes and centers, provides enhanced authorities (and possibly increased funding) for strategic planning and support of trans-institute initiatives, and standardizes a detailed series of reporting requirements covering research and other activities supported by NIH to promote greater accountability and stewardship of the funds invested in medical research.

NIH Structure
The bill does not eliminate or consolidate any existing NIH institutes or centers. However, the discussion draft divides the current institutes and centers into two major categories: “mission specific” institutes and “science enabling” institutes and centers. In addition, the discussion draft limits the total number of institutes with mission specific responsibilities to 14 and the total number of institutes and centers with science-enabling responsibilities to 10, effectively capping the number of NIH institutes and centers at the current level.

The draft legislation provides the NIH Director the authority to reorganize (by reducing or consolidating) the institutes and centers, by meeting the following requirements for that process: a public process carried out by regulation that involves all the affected constituencies, consultation with an external committee of scientific advisors, approval of the Secretary of the Department of Health and Human Services, and notice to Congress.

NIH Authorization Levels
The discussion draft also changes the NIH structure to four specific line item funding authorizations: (1) Office of the Director; (2) Division of Program Coordination, Planning, and Strategic Initiatives within the Office of the Director; (3) Institutes with mission-specific responsibilities; (4) Institutes and centers with science-enabling responsibilities. Currently, each NIH institute and center has a specific line item authorization for their annual funding level. The authorized funding levels for each of the four new line items are blank in the discussion draft.

The discussion draft also establishes a common fund for trans-NIH research activities (what Dr. Zerhouni describes as “a common fund for common needs”). At the beginning of a fiscal year, a predetermined percentage of overall NIH funding will be set aside to fund trans-NIH research activities. Funding set-aside for trans-NIH research activities will be allocated to the Institutes and Centers to conduct research activities identified through the Division of Program Coordination, Planning, and Strategic Initiatives and recommended by the advisory council. The overall size of the set-aside will gradually increase over the three-year authorization period.

More Authority to NIH Director
Under the draft legislation, the NIH Director will be responsible for program coordination, including conducting priority-setting reviews, to ensure that NIH’s research portfolio is balanced and free of unnecessary, duplicative research. The draft explicitly states that the authorities of the Institute and Center Directors to oversee research programs within the Institutes and Centers remain exactly the same as the current practice at NIH today. The NIH Director will ensure that scientifically-based strategic planning is implemented in support of research as determined by the Institute and Center Directors. The NIH Director will be responsible for program coordination across institutes and centers, to ensure that the research portfolio of NIH takes advantage of collaborative, cross-cutting research. The goal is to enhance the Director’s authority across NIH, but not to allow control of individual institutes or centers. Broader transfer authorities for the NIH Director are also a part of the draft bill.

The draft legislation also creates a new Division of Program Coordination, Planning, and Strategic Initiatives within the Office of the Director. The Division will identify research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that would benefit from additional research where such research involves the responsibilities of more than one Institute or Center. These “trans-NIH” research activities will be time limited. Only trans-NIH research projects recommended by an advisory council will receive funding.

Comments on the Discussion Draft
Some of the major concerns expressed about the NIH reauthorization legislation include:

New NIH Structure
The legislation modifies the way in which NIH programs are authorized and appropriated. By dividing the institutes into mission-specific and science-enabling categories, the legislation does not recognize that each has a mandate with defined priorities that address science and health matters from a specific perspective.

In addition, the new line item structure would authorize broad levels of funding to only four areas, changing the current process by which appropriations are allocated through line items for each institute and center. Another potential concern is that without specific appropriations for each institute and center, it could be up to the NIH Director to allocate the appropriated funds within NIH.

The Division of Program Coordination, Planning, and Strategic Initiatives would address initiatives that are beyond the purview or resources of any one institute or center but need to be undertaken by NIH as a whole. The proposed division would not supplant or dictate specific research plans or investigator-initiated research within the institutes and centers. Although establishing a mechanism to increase coordination and synergy across the institutes is a worthy objective, the amount of resources allocated for these crosscutting initiatives, the interaction of the proposed Division with the institutes and centers, and the scope of its authority are of concern.

Unspecified Authorization Levels
The current reauthorization draft does not include authorized funding levels for the four new line items. Rather than stating “such sums as necessary” (like past NIH reauthorization bills), the draft bill has a space in each line item for a specific authorized funding level. The threat to the research community is that the bill will authorize NIH funding levels that do not allow the Institutes to continue the momentum of discovery in the research enterprise. With Congress increasingly concerned about controlling federal discretionary spending, it could be a struggle to authorize NIH for an appropriate funding level. The last three years have shown the effect of funding NIH at less than the cost of medical inflation—difficulties in managing the new and already obligated research commitments and grants being funded at below the approved levels. Without the authorization for an appropriate funding level, all the momentum generated from the NIH budget doubling years will be quickly erased.

Broad Transfer Authorities
The draft legislation does not specify the percentages or provide details about the NIH Director’s new transfer authorities. Presently, the NIH Director has the authority to transfer 1 percent of the total funding within NIH. The only guidance about transfer authority in the draft legislation states that the NIH Director cannot transfer an amount of funding from an institute or center that would lower its funding below the fiscal year 2006 level.

If the NIH reauthorization bill were to increase the transfer authority to 3 percent of the total budget, this would represent $850 million, a significant amount to many NIH institutes and centers. Therefore, several groups have noted there are few checks and balances built into the draft legislation, which means that the appropriations committees would cede some authority to the NIH Director for a significant sum of money in terms of allocating funding to institutes and centers.

ASH will keep members informed about the NIH Reauthorization legislation as discussions continue in the House Energy and Commerce Committee. If you have questions, or need more information, please contact ASH Government Affairs Manager Jeff Coughlin at (202) 776-0544.