March 28 Before the House Labor, Health and Human Services, and Education (LHHS) Appropriations Subcommittee

NIH Director Dr. Collins Testifies Before the House on FY2013 Budget, NCATS Implementation

Legislative Update
March 20, 2012

On March 20, National Institutes of Health (NIH) Director Francis Collins, M.D., Ph.D. testified before the House Labor, Health and Human Services, and Education (LHHS) Appropriations Subcommittee on the President’s Fiscal Year (FY) 2013 budget request. Dr. Collins was joined by Thomas Insel, M.D., Director of the National Institute of Mental Health and Acting Director of NIH’s new National Center for Advancing Translational Sciences (NCATS), which was approved by Congress and initially funded in FY2012 appropriations. Dr. Collins and Dr. Insel comprised the first panel that testified.

Witnesses in the second panel included Scott Koenig, M.D., Ph.D. (MacroGenics), representing the Biotechnology Industry Organization (BIO), Todd Sherer, Ph.D. from the Michael J Fox Foundation for Parkinson’s Research, and Roy Vagelos, M.D., former Chairman and CEO of Merck & Co., Inc. and currently Chairman of the Board of Regeneron Pharmaceuticals, Inc. In addition to Chairman Denny Rehberg (R-MT) and Ranking Member Rosa DeLauro (D-CT), Members in attendance included Congs. Alexander (R-LA), Lummis (R-WY), Lowey (D- NY), Roybal-Allard (D-CA), and Simpson (R-ID).

The two topics most prevalent throughout the hearing were NCATS, especially its mission and funding, and the Institutional Development Awards (IDeA) program, which funds and was moved to the National Institute of General Medical Sciences (NIGMS) when the National Center for Research Resources (NCRR) was abolished and the majority of its programs moved to NCATS.

In his opening statement, Chairman Rehberg cited a number of concerns with the NIH budget proposal, including cuts to the IDeA program, changes to the National Children’s Study, and preserving the Clinical and Translational Science Awards (CTSA) program, which was moved from the NCRR and comprises the majority of the NCATS budget. In praising the basic research function of NIH, he also suggested NIH needs to work on its “governance” to ensure it maintains its traditional balance of basic versus translational research and extramural versus intramural research. Finally, he voiced concerns with NCATS, stating multiple times that NIH should not compete with industry in developing drugs.

Ranking Member DeLauro spoke passionately about the potential damage from NIH cuts stating that, accounting for inflation, the NIH budget had shrunk by five percent since 2010 and 16 percent since 2003. She cited the United for Medical Research report released on March 19 which detailed the number of jobs and economic impact related to NIH funding to academic Institutions around the country.

In his testimony, Dr. Collins stressed the NIH’s impact on health and medical advances, as well as its significant beneficial effect on the economy. He also described his vision for how NCATS could play a pivotal role in working with industry to “re-engineer” the drug discovery pipeline, especially to eliminate “the bottlenecks that have created the so-called Valley of Death between discovery and translation.” He noted that, in FY2012, there was little new funding for NCATS, as it was comprised primarily of existing programs from other NIH Institutes and Centers (I/Cs) other than the new funding for the Cures Acceleration Network (CAN) at $10 M. He did note that the NCATS budget would increase for FY2013, driven primarily by CAN funding at $50 million. He concluded by stating that, although translational research activities at other I/Cs would continue as in the past, all would benefit from NCATS’ efforts.

During questioning, Chairman Rehberg stated that, while he was supportive of NCATS, he didn’t “like the way NCATS came about” and also questioned whether the commitment to NCATS signaled a divestment in basic, extramural research. Dr. Collins apologized for the fast pace of the NCATS process, stating he was an “impatient physician-scientist” who wanted to prove the government doesn’t have to move slowly. He went on to assure the Subcommittee that the percentages for basic research and clinical research have essentially remained steady over time (hovering around 54% and 46%, respectively) and NIH has no plans to change that.

There was back-and-forth during the questioning on the proposed cuts to the IDeA program, particularly from Congs. Alexander, Simpson, and Lummis. Dr. Collins re-stated the President’s budget interpretation that additional funding for IDeA in FY2012 was a one-time opportunity while Chairman Rehberg pushed back, stating that the Subcommittee had never intended for that in its final Report Language. Despite their concerns about IDeA program funding, both Congs. Simpson and Lummis praised NIH. Cong. Simpson called it the “best kept secret in Washington,” while Cong. Lummis stated she strongly supported the federal role in supporting biomedical research. She also expressed concern about whether money was being taken away from basic research and IDeA for NCATS. Dr. Collins ultimately pointed out that, in a flat or reduced budget environment, it wasn’t possible to fund everything, and it was these lost opportunities that “kept him up at night.”

Cong. DeLauro concluded her questions by asking Dr. Collins what the current success rate is for young investigators compared to ten years ago, as well as the impact of sequestration [mandatory cuts, per the Budget Control Act of 2011]. Dr. Collins responded that young investigators currently had a one-in-six chance of being funded, compared to a one-in-three chance a decade ago. Citing the Congressional Budget Office (CBO) estimate of a 7.8 percent NIH cut in sequestration, he described the potential effect as “devastating” and said that 2,300 grants that NIH had planned to fund could not be awarded. He also provided statistics to compare U.S. funding of biomedical research to other countries, stating that China was giving research a 26 percent boost, India was increasing by double digits, Europe was going to increase research investment by 40 percent despite current economic troubles, and that Russia had planned a 65 percent increase in research investment.

In the second panel, Dr. Koenig and Dr. Sherer voiced support for NIH’s plans regarding NCATS, while Dr. Vagelos spoke strongly in opposition to NCATS, stating that private industry could best do drug development and that NIH would be better off investing the funds in supporting doctoral training. However, all three panelists agreed on and reiterated the importance of NIH’s investment in basic research and its relationship to industry’s development of drugs and devices.

Note: An NIH summary of the House hearing also appears in the inaugural edition of its NCATS newsletter.