FNew federal agencies have enjoyed a better reputation on Capitol Hill in recent decades than the National Institutes of Health. But a host of challenges are fueling calls for reform on Capitol Hill that the agency has a hard time fending off without making concessions.
The NIH’s reputation, coupled with enthusiasm about the agency’s role in advancing discoveries to improve health, made possible a doubling of the agency’s budget that ended 20 years ago. Many members of Congress remained sympathetic to the agency’s challenges during the ensuing period of flat or declining budgets, particularly Republicans, who tend to be less supportive of nondefense or security-related domestic spending.
Over the past decade, the agency’s reputation—and its cadre of well-positioned members of Congress—has resulted in several years of significant growth, helping to regain ground lost as the crisis doubled.
Unfortunately for the NIH and its vast universe of influential external stakeholders, including universities, academic medical centers, nonprofit patient advocacy groups, and the medical products industry, the agency finds itself in a perfect storm of challenges. These include:
- A leadership change after the more than 12-year tenure of Director Francis S. Collins.
- There are still questions and concerns about the agency’s support for gain-of-function research and activities related to SARS-CoV-2, the virus that causes Covid-19, including its approach to long-term Covid research.
- Budgetary pressures reminiscent of those of the late 2000s and early 2010s.
- Questions — even from longtime supporters — about the effectiveness of the NIH’s culture led to a push to make the Advanced Research Projects Agency-Health (ARPA-H) independent of the agency, including its headquarters in Bethesda.
- Retirements of many of the most pro-NIH lawmakers at the top of both the authorizing and budget committees, such as former Senators Roy Blunt (R-Mo.), Richard Burr (R-N.C.), and Richard Shelby (R-Ala.), and former Rep. Fred Upton (R-Mich.), along with declining support for the NIH among the Republican caucus that has historically been home to many of its most effective legislative champions.
In addition to these challenges, influential leaders in Congress are also calling for substantive changes at the NIH. In particular, top Republicans on the two committees that oversee the agency, the House Energy & Commerce Committee and the Senate HELP Committee.
Taken together, these challenges point to growing frustration with the agency and should alert the NIH and its many supporters that meaningful changes may be needed to restore its once-premier bipartisan reputation. Following a request for information in the fall of 2023, HELP Committee Sen. Bill Cassidy (R-La.) published a white paper in May focused on modernizing the NIH. The paper touched on several concerns, including balancing support for basic versus applied research and between “investigator-initiated” and targeted opportunities, failing to provide redundant support for research activities and identifying efficiencies, strengthening the biomedical research workforce, and improving transparency and accountability to Congress and the public.
In June, outgoing Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) released a more ambitious framework for reforming the NIH. The framework includes several changes that, if implemented, would significantly alter the NIH’s structure. They include:
- The number of institutes and centers would be reduced from the current 27 to 15. Consolidated institutes would include a “National Institute on Body Systems Research,” which would be the second-largest institute or center under current funding levels; institutes focused on the immune system and arthritis, dementia and disability research; and an Institute for Innovation and Advanced Research. It would also consolidate ARPA-H with several other entities and form a National Institute on Innovation and Advanced Research. The House Budget Committee included consolidation in its proposed FY2025 budget bill for the NIH, which was unveiled last week.
- Establishing a commission to propose a “comprehensive, overall evaluation of the NIH’s performance, mission, objectives, and programs.”
- Establishing a maximum term of office of 10 years for directors of institutes or centres.
- Addressing indirect costs – the often significant sums paid to a researcher’s home institution to cover the institution’s overhead costs – can be done in a number of ways, including by setting indirect rates as a percentage of the total award, by capping such costs, or by incentivising awards to institutions with lower indirect costs and requiring that such rates be publicly available.
- Prioritize awards to investigators with lower NIH funding levels.
- Strengthening oversight and reporting requirements for grant recipients to address concerns about foreign influence on research funding and establishing an external review process for gain-of-function research proposals.
Some of these issues, such as term limits for directors, have been explored before. For example, the 21st Century Cures Act included five-year terms for institute or center directors, but did not limit the number of terms a director could serve. That act also included provisions intended to address duplication of research, improve transparency and strengthen NIH strategic planning, and establish a program to support early-career investigators. When NIH proposed imposing a hard cap on the number of grants investigators could receive, it quickly withdrew the plan after encountering significant opposition.
The 21st Century Cures Act was widely embraced by the NIH and its stakeholders and was developed iteratively and in a positive climate. The Energy & Commerce framework, however, is, by its omission and title, clearly a reform plan.
The last major reauthorization of the NIH occurred in late 2006 and early 2007. While that act authorized the Common Fund to support cross-cutting research programs and established the current composition of NIH institutes and centers, it also eliminated several disease-specific authorizations in exchange for increased reporting.
If the 2006-07 reforms did anything, they limited the influence of many in Congress over NIH by freezing the passage of legislation deemed disease-specific. The law also made Congress’s budgetary authorities more influential, making the language of the annual budget report—nonstatutory guidance for NIH offices, institutes, and centers—the primary tool for shaping research activities and priorities. Ultimately, the 2006-07 reforms may have been most beneficial to agency officials who benefited from a kid-glove approach to oversight, and least beneficial to outside stakeholders and most members of Congress who did not sit on budget committees and who found themselves lacking in ways to influence the agency’s activities.
What, if anything, will happen to the NIH in terms of future modernization or reform remains to be determined. One thing is certain: given the limited congressional calendar for the remainder of the current 118th Congress, it will be up to the 119th and possibly other Congresses to take up this mantle.
A closely divided government and the incremental nature of the legislative process would suggest that more aggressive reform proposals would face stronger headwinds. At the same time, a tight budget environment and some blemishes on the agency’s reputation could help keep some reform proposals from moving forward.
It will be tempting for those inside and outside the NIH — including those who rely heavily on the grant — to push back aggressively and dismiss calls for reform as politically motivated. But to do so would be to ignore legitimate concerns and frustrations and miss opportunities for improvement.
A more productive way forward would involve recognizing that some changes to the agency and its processes are needed and that doing so could have long-term benefits. And for those proposals that could have a detrimental effect, stakeholders should make compelling arguments based on evidence, just as they would in scientific papers.
Unlike many other federal agencies, the NIH has a long history of bipartisan support and a track record of concrete success. With some introspection about what drives calls for reform and a commitment to working in partnership, a return to that bipartisan bonhomie may be possible.
Nick Manetto leads Faegre Drinker’s Federal Policy, Advocacy and Consulting Team and has been active in NIH policy on and off Capitol Hill for more than 20 years.
