Few federal agencies have enjoyed a more sterling reputation on Capitol Hill over the past several decades than the National Institutes of Health. But a bevy of challenges are spurring calls for reform on Capitol Hill that may be difficult for the agency to fend off without making some concessions.
The reputation of the NIH, coupled with excitement about the agency’s role in advancing discoveries to improve health, made possible a doubling of the agency’s budget that concluded 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 are typically less supportive of non-defense or security domestic spending.
Over the past decade, the agency’s standing — and its cadre of well-positioned congressional backers — resulted in multiple years of sizable growth, helping recoup ground lost following the doubling bust.
Unfortunately for the NIH and its extensive universe of influential external stakeholders, including universities, academic medical centers, nonprofit patient advocacy groups, and the medical products industry, the agency is finding itself navigating a perfect storm of challenges. These include:
- A leadership transition following the more than 12-year run of director Francis S. Collins.
- Lingering questions and concerns about the agency’s support of gain-of-function research and activities related to SARS-CoV-2, the virus that causes Covid-19, including its handling of long Covid research.
- Budgetary pressures that are reminiscent of those during the late 2000s and early 2010s.
- Questions — even from longtime supporters — about the effectiveness of NIH’s culture that led to a push for the Advanced Research Projects Agency-Health (ARPA-H) to have independence from the agency, including its Bethesda headquarters.
- Retirements of many of the most pro-NIH lawmakers atop both authorizing and appropriations committees, such as former Sens. Roy Blunt (R-Mo.), Richard Burr (R-N.C.), and Richard Shelby (R-Ala.), and former Rep. Fred Upton (R-Mich.), along with diminished support for the NIH among the Republican caucus that has historically been the home of many of its most effective legislative champions.
In addition to these challenges, calls for substantive changes to the NIH are being aired by influential leaders in Congress, notably the top Republicans on the two committees with oversight authority over the agency, the House Energy & Commerce and the Senate HELP panels.
Taken together, these challenges indicate a growing frustration with the agency and should give notice to the NIH and its many supporters that some meaningful changes may be needed to restore its once first-rate bipartisan reputation. Following a fall 2023 request for information, Senate HELP Committee Ranking Member Bill Cassidy (R-La.) in May issued a white paper focused on modernizing NIH. The document touched on several concerns, including balancing support for basic vs. applied research as well as between “investigator initiated” and targeted opportunities, not providing redundant support for research activities and identifying efficiencies, strengthening the biomedical research workforce and improving transparency and accountability to Congress and the public at large.
In June, outgoing Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) issued a more ambitious framework for NIH reform. The framework contains several changes that, if made, would significantly alter the NIH’s structure. These include:
- Collapsing the number of institutes and centers from the current 27 to 15. Consolidated institutes would include a “National Institute on Body Systems Research” that would be the second largest institute or center under current funding levels; institutes focused on the immune system and arthritis, dementia, and disability-related research; and an institute on innovation and advanced research. It would also consolidate ARPA-H with some other entities and form a National Institute on Innovation and Advanced Research. House appropriators included consolidation in their proposed Fiscal Year 2025 spending bill for the NIH that was unveiled last week.
- Creating a commission to propose a “comprehensive, wholesale review of the NIH’s performance, mission, objectives, and programs.”
- Establishing a 10-year maximum term limit for directors of institutes or centers.
- Addressing indirect costs — the often-sizable funds paid to a researcher’s home institution to cover the institution’s overhead — in a variety of ways, including establishing indirect rates as a percentage of a total award, capping such costs, or incentivizing awards to institutions with lower indirect costs and requiring that such rates be publicly accessible.
- Prioritizing awards to investigators with lower levels of NIH funding.
- Increasing oversight and reporting requirements on grantees to address concerns about foreign influence into research funding and establish an external review process over gain-of-function research proposals.
Some of these themes, such as director term limits, have been pursued before. For example, the 21st Century Cures Act included five-year terms for institute or center directors but did not place a limit on how many terms a director could serve. That law also included provisions intending to address duplicative research, improve transparency, and strengthen NIH strategic planning, as well as establish a program to support early-career investigators. When the NIH proposed instituting a hard cap on the number of grants researchers could hold, it quickly retracted the plan after encountering sizable pushback.
The 21st Century Cures Act was widely embraced by the NIH and its stakeholders and developed in an iterative manner and positive climate, but the Energy & Commerce framework, by its own omission and title, is clearly a reform plan.
The last significant reauthorization of the NIH came in late 2006 and early 2007. While that law authorized the Common Fund to support cross-cutting research programs and established the current complement of NIH institutes and centers, it also struck several disease-specific authorizations in exchange for increased reporting.
If the reforms of 2006/2007 did anything, they limited the influence of many in Congress over the NIH by chilling authorization of laws that were viewed as being disease specific. The law also made Congressional appropriators more influential and made annual appropriations report language — non-statutory directives to NIH offices, institutes, and centers — the primary tool to shape research activities and priorities. In the end, the 2006/2007 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 not serving on appropriations committees who found themselves lacking in ways to influence agency activities.
What, if anything, will happen to the NIH in terms of future modernization or reform remains to be determined. One certainty is that given the limited Congressional calendar for the remainder of the current 118th Congress, it will fall to the 119th and possibly other Congresses to take up this mantle.
A narrowly divided government and the incremental nature of the legislative process would suggest that the more aggressive reform proposals will face stiffer headwinds. At the same time, a tight budgetary climate and some blemishes on the agency’s reputation could see some of the reform proposals advance.
It will be tempting for those inside and outside of the NIH — including those heavily reliant on its purse — to push back aggressively and dismiss calls for reform as being politically motivated. But doing so would fail to heed legitimate concerns and frustrations and miss opportunities for improvement.
A more productive path forward would involve conceding that some changes to the agency and its processes are needed and could lead to long-term benefit. And for those proposals that may have a deleterious effect, stakeholders should make cogent arguments grounded in evidence, just as they would in scientific papers.
Unlike many other federal agencies, the NIH has a long history of bipartisan support and a record of concrete success. Through some introspection as to what is driving calls for reform and a commitment to work in partnership, return to that bipartisan bonhomie may be possible.
Nick Manetto leads the Federal Policy, Advocacy and Consulting Team of Faegre Drinker and has spent more than 20 years working on NIH policy on and off Capitol Hill.