The June 11-12 National Institutes of Health (NIH) Advisory Committee to the Director (ACD) meeting included the discussion of a number of important issues for the agency, including its fiscal year (FY) 2016 budget and its efforts to develop a five-year strategic plan by December 2015.
FY 2016 Budget
The newly appointed Associate Director for Legislative Policy and Analysis, Adrienne Hallett, provided a legislative update to the ACD, including a timeline for the year ahead. Hallett who joined the NIH after 14 years working for Congress, including the Senate Appropriations Committee, highlighted Congressional activities that would impact the NIH, such as the House (June 24) and Senate (June 25) markups of the Labor, Health and Human Services and Education (Labor-HHS) appropriations bills, potential floor consideration of H.R. 6, the 21st Century Cures Act (see related story), and the Supreme Court decision regarding the Affordable Care Act (King v. Burwell). Hallett also predicted that Congress would pass a temporary continuing resolution (CR) in September to keep the government operating into FY 2016 and leading up to November when Congress will need to address the debt ceiling.
Reflecting on the year ahead, Hallett pointed to a “paradox” for NIH—support for the agency has never been stronger but Congress’ appetite to address the issue of sequestration and a larger fiscal compromise is weak. Hallett pointed out, however, that when appropriators have the money they are likely to give it to NIH. She further observed that Members of Congress are getting creative in an effort to help the NIH. The creation of the Senate NIH Caucus by Senators Lindsey Graham (R-SC) and Richard Durbin (D-IL), is “one of the strongest and most specific statements of support for the NIH,”
The 21st Century Cures Act would provide an additional $10 billion in funding over five years via a new Innovation Fund. However, as Hallett observed, these “funds are divided up more specifically than appropriators typically [stipulate].” She noted that the bill also creates a new Accelerating Advancement Program which, while not well-defined at this point, would direct money to the institutes and centers, where it would have to be matched dollar for dollar. Rep. Fred Upton (R-MI) would like to see consideration of the bill completed by the end of the year, but the Senate Health, Education, Labor, and Pension Committee (HELP) is on a much slower trajectory. HELP is focused on reauthorizing the K-12 education program, a reflection of a difference in the missions of the committees with jurisdiction over the NIH.
An additional potential opportunity for increased funding for NIH, Hallett explained, is the consideration of the debt ceiling. She highlighted Senate Majority Leader Mitch McConnell’s May 1 statement: “I always think a debt ceiling is a good tool to carry something. I hope we can add something to it.”
Lastly, in terms of the dollars actually appropriated, Hallett noted four other bills introduced in the 114th Congress that, if enacted, would provide supplemental funding to NIH (See Update, February 15, 2015 and February 24, 2014):
1) Accelerating Biomedical Research Act (S. 318/H.R. 531), introduced by Senator Barbara Mikulski (D-MD) and Rep. Rosa DeLauro (D-CT)
2) American Cures Act (S. 289/H.R. 2104), introduced by Senator Richard Durbin (D-IL) and Rep. Anna Eshoo (D-CA)
3) Medical Innovation Act of 2015 (S.320/H.R. 744), introduced by Senator Elizabeth Warren and Rep. Chris Van Hollen (D-MD)
4) Permanent Investment in Health Research Act of 2015 (H.R. 777), introduced by Rep. Kathy Castor (R-FL)
NIH Director Francis Collins updated the ACD on NIH’s effort to create a NIH-wide strategic plan. According to Collins, NIH has been contemplating how to take advantage of the Congressional directive in the Consolidated and Further Continuing Appropriations Act, 2015 (H.R. 83) mandating that NIH create an agency-wide, five-year strategic plan to “synthesize what is already the effort of the institutes and centers that have their own strategic plans and turn it into a document that could serve the NIH well in terms of explaining how the agency set priorities and what direction it thinks biomedical research is going.”
The NIH’s efforts are being led by NIH deputy director Larry Tabak and a group of institute directors. Tabak shared a draft framework of these efforts with the Committee. Congress wants the agency to “conduct priority setting reviews” to make sure the NIH’s portfolio is “balanced and free of unnecessary duplication.” In addition, the framework takes advantage of the collaborative and cross-cutting research and put together the data used to assess research, Tabak explained to the ACD.
He noted that there is also a provision in the 21st Century Cures Act directing the agency to create a trans-NIH strategic plan and specifies that it include certain elements (See Update, May 9, 2015). The bill also mandates that investments should be identified and that overarching trans-NIH strategic areas should include rare pediatric diseases and conditions.
According to Tabak, the working group came up with criteria that would dictate what should or should not be part of the plan. For example, it should clearly articulate the highest priorities of the NIH overall, describe how the NIH will achieve these priorities, and be a living document that will require refinement throughout the lifecycle. The report should not describe all the many important things that NIH does and will do in the future or address priorities of the individual institutes and centers (ICs) since each IC has its own strategic plan.
So far, Tabak explained, NIH has reviewed the strategic plans and identified common themes among the 24 ICs; developed a draft framework for the strategic plan by subgroup of directors; and discussed the draft framework with the NIH Executive Committee, the Steering Committee and with the IC directors. The next step is to present the draft framework to the ACD for feedback and guidance on implementing a public planning process, followed by the development of a subsequent draft to be shared with NIH stakeholders. In addition, NIH intends to solicit public comment from stakeholders, including patient advocacy groups, researchers, and industry, via a request for information (RFI) and a series of webinars in July and August. The feedback will be integrated and an amended draft plan will be presented at the National Advisory Council meetings in September, with an updated plan reviewed by the ACD at its December meeting. NIH expects to transmit the strategic plan to Congress by mid-December.
The proposed framework presented by Tabak includes an overarching goal: “Support research in pursuit of fundamental knowledge about the nature and behavior of living systems, and the application of that knowledge to extend healthy life and reduce illness and disability.” It identifies seven trans-NIH priority areas that considers return on investment and contributes to expanding knowledge to improve public health through biomedical research: (1) cancer, (2) infectious and immunological diseases, (3) cardiovascular disease, (4) diabetes and obesity, (5) brain diseases and disorders, (6) human development, and (7) chronic diseases and conditions.
The draft frameworks also includes four major goals to achieve the above overarching goal and trans-NIH priority areas: (1) basic research; (2) translational, clinical, and population based research; (3) workforce, research infrastructure, preparedness; and (4) enhancing stewardship.
The working group received a substantial amount of feedback and suggestions from ACD members. Collins and Tabak indicated that they would take this feedback to the working group and revisit the organizing principles of the framework.