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Senators Harkin and Specter Introduce An Emergency Supplemental Appropriations Bill to Add $5.2 Billion to FY2008 NIH Funding; Action Comes After Senate LHHS Appropriations Hearing on FY2009 NIH Funding Featuring NIH Director Dr. Zerhouni

Legislative Update
July 17, 2008

Senate FY2008 NIH Emergency Supplemental Appropriations

Senator Arlen Specter
On the afternoon of July 16, Senator Arlen Specter (R-PA), the Ranking Member of the Senate Labor, Health and Human Services, and Education (LHHS) Appropriations Subcommittee, on behalf of Subcommittee Chairman Senator Tom Harkin (D-IA), made a statement on the Senate floor introducing Senate Bill 3272, which would make emergency supplemental appropriations of $5.2 billion for the National Institutes of Health (NIH) for the Fiscal Year (FY) ending September 30, 2008. Of the $5.2 billion contained in the bill, $4 billion would be provided to the Office of the NIH Director to be transferred to the Institutes and Centers, and $1.2 billion additional would go directly to the National Cancer Institute (NCI) to enhance cancer research.

Although Senator Specter, who just completed a chemotherapy regimen for Hodgkin’s disease, noted that the Senate’s FY2009 Appropriations bill (S. 3230) does increase NIH funding by $875 million (net of an increase over FY2008 of $1.025 billion minus $150 million additional funding for Global AIDS), that increase of 3.5 percent just matches the biomedical inflation rate and does not begin to restore the 13 percent loss of purchasing power lost by NIH over the past five funding cycles. The $5.2 billion supplemental appropriations would just make up that inflationary loss. As a point of reference, the President’s FY2009 proposed budget would flat-fund the NIH.

In his statement, Senator Specter noted that the special emphasis of funds for cancer research emerged from discussions with leading cancer patient advocacy organizations, which have estimated the cost of “conquering” cancer at $335 billion, or approximately $22 billion a year over the next fifteen years.

This Senate action comes just two weeks after the President signed an FY2008 Supplemental Appropriations bill to primarily fund the wars in Iraq and Afghanistan that included $150 million in additional funding for the NIH. These funds, intended to underwrite an additional 246 research grants in FY2008, are to be distributed to the Institutes, Centers, and the NIH common fund along the lines of the initial FY2008 NIH appropriations. The NIH has not yet announced the amount to be distributed to the National Eye Institute (NEI).

Dr. Zerhouni Testifies at Senate LHHS Appropriations Subcommittee Hearing

NIH Director Elias Zerhouni
On the morning of July 16, after an opening statement by Chairman Harkin, NIH Director Elias Zerhouni, M.D., testified before the LHHS Appropriations Subcommittee on NIH’s accomplishments and challenges. He was joined by four Institute Directors: Francis Collins, M.D., Ph.D. (National Human Genome Research Institute); Anthony Fauci, M.D. (National Institute of Allergy and Infectious Diseases); Elizabeth Nabel, M.D. (National Heart, Lung and Blood Institute); and John Niederhuber, M.D. (National Cancer Institute).

Dr. Zerhouni further elaborated on previous testimony about NIH advances that are transforming the research and healthcare practice paradigm to one that is predictive, personalized, preemptive, and participatory. He noted that the almost-daily announcement of genes associated with specific diseases, which has emerged from the Human Genome Project, represents a “revolution of knowledge” that NIH must take advantage of by being flexible and adaptive. For example, he stated that NIH must follow up on these gene discoveries by: confirming the findings in large population-based studies; better understanding the complexity of the associated disease process and how the biology works to identify potential targets; and translating the discoveries into prevention, diagnosis, and treatment.

Regarding NIH’s budget, Dr. Zerhouni stated that “medical research is a long-term process that does not operate on a twelve month cycle” and that predictable funding is necessary to sustain the research enterprise. He added that a reasonable success rate is also necessary to maintain the scientific infrastructure (for the first time, the FY2009 NIH success rate is expected to fall under 18 percent), especially to encourage young and first-time investigators. Regarding the latter, when asked what NIH would do with a $1 billion dollar increase, Dr. Zerhouni stated that the first priority should be funding young/first-time investigators by putting a “lock box’ on a specific amount of appropriations. In so stating, he noted that “NIH should be funding at least 3,000 new scientists a year, and it is currently less than that” (FY2008 funding for new/first-time investigators is $60 million, and proposed FY2009 funding is $108 million). Other key NIH priorities with increased funding include: encouraging risk-taking/innovation in research; having adequate resources to conduct clinical trials; and encouraging collaboration across disciplines.

Dr. Zerhouni Comments on Extramural Research Conflict of Interest Issues

The Report Language accompanying the Senate’s FY2009 LHHS Appropriations bill requires the Secretary of Health and Human Services (DHHS) to issue an Advance Notice of Proposed Rulemaking (ANPR) to solicit public comment in advance of modifying regulations governing financial conflicts of interest among extramural investigators receiving grant support from the NIH.

In response to a question from Senator Harkin about the need for such regulations, Dr. Zerhouni stated that:

  • DHHS has already put into effect rigorous safeguards regarding conflict of interest for NIH personnel and intramural investigators.

  • There is value to a well-managed interaction between the public and private funding of research, and it is up to Congress, the NIH, and the receiving academic institutions to strike that fine balance and to have an appropriate and transparent process.

  • Any regulation must stratify the “risk” associated with public/private interaction, for example, basic research may present less risk than a clinical trial.

  • He does see the need for cultural changes within the receiving academic institutions, and that enforcement of any policy may need to be done through a third-party, independent organization that is more rigorous than the current policy of “self-policing.”

Note that, although NEI Director Paul Sieving M.D., Ph.D., did not testify, NEI did provide a written statement. In that regard, Chairman Harkin noted that it is the Subcommittee’s intent to resume hearings including all Institute and Center Directors in the FY2010 appropriations process, as was done in the FY2008 process.