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NIH Director Dr. Elias Zerhouni Updates Congress on Status of NIH Reauthorization Legislation

Legislative Update
September 10, 2008


NIH Director Elias Zerhouni
Yesterday, the House Energy and Commerce (E&C) Committee’s Health Subcommittee held a hearing entitled The National Institutes of Health (NIH) Reform Act of 2006: Progress, Challenges, and Next Steps at which NIH Director Elias Zerhouni, M.D., was the sole witness. The House E&C Committee, along with the Senate Health, Education, Labor and Pensions (HELP) Committee, have authorizing jurisdiction over the NIH, and NAEVR worked closely with both in the development of the NIH Reform Act of 2006, which passed into law in December 2006. The law enhanced the authority available to the NIH Director’s office to conduct strategic planning and to facilitate and fund trans-NIH research, and created more budgetary, organizational, and programmatic transparency and standardized information management systems.

In his opening statement, which mirrored that of full E&C Committee Chairman John Dingell (D-MI), Subcommittee Chair Frank Pallone (D-NJ) noted that, although the law was a significant step in the right direction, the NIH still faces many hurdles—including: attracting and retaining young scientists, creating opportunities for trans-disciplinary research, and managing the portfolio of extramural and intramural research—at a time of decreased funding. Along party lines, the Subcommittee’s Democratic members criticized the President’s Fiscal Year (FY) 2009 budget request, which would have flat-funded the NIH (net loss with the biomedical inflation rate of 3.5 percent factored in).

E&C Ranking Member Cong. Joe Barton (R-TX), who chaired the Committee in the 109th Congress, expressed his regret that Congress has not been able to appropriate the funding increases authorized in the bill. He also expressed concern about the continued introduction of disease-specific legislation in the Congress, as he had hoped that giving the NIH the new tools in the legislation would enable it to set disease research priorities. As he stated, "Scientists should make decisions, and NIH should not be micromanaged by Congress nor the advocacy groups." He concluded his opening statement by acknowledging that the NIH was already in the second year of a three year reauthorization, and that his priority in this hearing was to determine what other tools NIH needed to better plan for the future of biomedical research.

Dr. Zerhouni’s initial comments, which mirrored his July 19 testimony to the Senate Labor, Health and Human Services, and Education (LHHS) Appropriations Subcommittee, focused on the rapid pace of new discovery and how the research enterprise must be flexible and collaborative to meet that challenge. As in his Senate testimony, he acknowledged that the initial discovery of gene variants associated with Age-related Macular Degeneration (AMD)—made in 2005 as a direct result of the Human Genome Project—has grown into an almost-daily announcement of gene discoveries associated with a multitude of diseases. He emphasized that those discoveries must be translated into prevention, diagnostic, and treatment strategies, especially if the NIH is to conform with the new paradigm for healthcare research and delivery that is predictive, preemptive, personalized, and participatory.

With respect to implementation of specific requirements of the law, he announced that:

  • The NIH common fund for trans-Institute research is in place, and that it has been directly funded by Congressional appropriators, serving essentially as a “venture capital” funding mechanism for breakthrough science, especially that which is "high risk, high reward."

  • NIH has submitted its first required biennial report to Congress.

  • NIH has developed and is currently implementing the Research, Condition, and Disease Categorization (RCDC) system using a unique knowledge management software that will account for NIH investment in disease areas, the latter of which he acknowledged is of great interest to Congress and to disease advocacy groups. He cautioned, however, that the RCDC will present data differently than in the past and that the system will likely evolve over time.

  • NIH had just announced the composition of the Scientific Management Review Board (SMRB), which will develop recommendations regarding NIH management and structure.

Dr. Zerhouni acknowledged that, although the law has helped NIH to streamline governance and to better plan short-term, its ability to plan medium-to-long term has been limited by the lack of predictable and sustained funding increases. He cited that lack of predictable funding as the primary cause of NIH’s biggest challenge—workforce issues, specifically those related to the training and retention of new investigators and clinician-scientists. This concern was echoed by almost every Member in attendance, especially in relation to the United States’ competitiveness with other nations, prompting Cong. Anna Eshoo (D-CA) to urge Congressional action on science education such that "the spigot is not turned off."

In response to a concluding question from Cong. Barton about what Congress could do in the next reauthorization, Dr. Zerhouni identified the following:

  • Management of disease-specific requests, specifically how "NIH can remain flexible in responding without creating permanent structures (e.g., Institutes) or funding entitlements."

  • Equalize authorities over all Institutes to "create a level playing field, since no one disease is superior to another and they increasingly appear to be integrated."

  • The process by which NIH is funded does not support medium-to-long-term capital investment, as it is not currently predictable.

NAEVR has an entire section devoted to its NIH Reauthorization activities on its Web site.