By
Jamie Bay Nishi, CEO, ASTMH; and
Jodie Curtis, Senior Policy Advisor, Venable LLP
In June, U.S. Congressional House Energy and Commerce (E&C) Chair Cathy McMorris-Rodgers (R-WA), in conjunction with Chair Robert Aderholt (R-AL), released a
framework and sweeping proposal to reform NIH, with an invitation for public comment by mid-August. Less than two weeks later, House appropriators announced their
fiscal year 2025 budget plan with a major reorganization of NIH factored in as if it were a done deal. Here is a brief recap of the proposed changes that would impact global health research:
Mergers & Acquisitions at NIH
The most radical idea on its face might be decreasing the numbers of NIH Institutes and Centers from 27 to 15 centers. Changes would include splitting the National Institute of Allergies and Infectious Disease (NIAID) into two: the National Institute on Infectious Diseases and the National Institute on Immune System and Arthritis. Fogarty International Center would be consolidated with four other Centers to create a National Institute for Health Science Research. Furthermore, the Advanced Research Projects Agency for Health (ARPA-H), an agency founded in 2022 to serve as a civilian counterpart to the Defense Advanced Research Projects Agency, and intended explicitly to sit outside of NIH, would be brought under NIH and merged with existing Institutes to become the National Institute on Innovation and Advanced Research (see charts below).
Mostly flat funding with one big exception
In terms of budget, the two derivatives of NIAID are proposed to receive approximately $3.3 billion each, which, combined, is an increase from NIAID’s fiscal year 2024 (FY24) allocation. NIH’s Fogarty International Center, under its new home within the National Institute on Health Sciences Research, is proposed to receive level funding from the previous enacted year (FY24) at $95 million, although it’s unclear whether there will be any shifts in how resources under the new Institute will be allocated once rolled together. The new Institute housing ARPA-H is proposed to be cut by $1 billion, essentially wiping out its entire budget, likely including its Division of International Affairs, or severely cutting funding across all of the institutes it would be merging with.
Revisiting how work is done by NIH and its grantees
There are many other provisions in the E&C proposal that could have huge impacts as well. A few that may impact our community directly include:
- Introduction of term limits for Institute and CenterlLeadership. Every Institute or Center Director would have a five-year term, with the ability to serve two consecutive terms, if approved by the NIH Director.
- Limit on awards to primary instigators. There would be a focus on providing grants and awards only to primary investigators that do not have more than three ongoing concurrent NIH engagements. Grants would need to consider opportunities to continue to bolster and support early-stage investigators; encourage systematic replication studies across research portfolios and fields; and prevent research and data waste, fraud and misconduct.
- Demanding accountability from grantees working with foreign subgrantees. Ensure primary grantees are complying with all requirements, including written attestations, to share and provide access to all relevant and supporting information and documentation related to research being conducted by any foreign subgrantee.
- Incorporate a National Security Review. Incorporate a specific national security or intelligence community review into the grant and award process for grants that involve research occurring by, or on behalf of, entities or actors that have been designated as foreign adversaries.
Where do we go from here?
Although there are those In the House and Senate who want NIH reform, it’s unclear how much traction the reform proposal has within the U.S. Senate, as Sen. Bill Cassidy (R-LA) issued a NIH
white paper earlier this year with more modest recommendations to modernize NIH. In recent years, House appropriators have proposed funding cuts to U.S. health agencies, but the Senate has typically stepped in to mitigate them when negotiating final budget packages. . We expect the Senate will want to have a say in any NIH reforms, and this will likely slow down the process. Therefore, we do expect the conversation on NIH will continue into the new year and the new Congress.
ASTMH is actively engaging with fellow scientific societies, friends of NIH and global health advocates to compare notes and try to gain a better understanding of the rationale behind some of the proposed changes. ASTMH will provide direct commentary to the House Energy & Commerce Committee and keep our community informed as deliberations progress.
While some aspects of the reform proposal may be welcome, we are committed to ensuring that NIH’s critical global health-related research is not diluted or diminished through any reorganization or funding cuts. Stay tuned!
Source: House Energy and Commerce Committee.
Reforming the National Institutes of Health: Framework for Discussion, Pages 6 and 7, June 2024.