With sweeping NIH reform on the table, GOP previews new era of research scrutiny

WASHINGTON — There seems to be broad agreement that change is coming for the National Institutes of Health. It is just a matter of how much — and which institutes see their fates upturned.

Two House Republicans whose committees oversee the agency on Friday laid out a sweeping plan to nearly halve the number of NIH institutes and centers, establish director term limits, restrict certain infectious disease research, and bolster grant reporting, among dozens of proposed changes. They shared their plans in a whitepaper and in an opinion piece in STAT.

The overarching proposal — particularly winnowing down the number of institutes and centers from 27 to 15 by merging several — goes far beyond post-Covid promises to put guardrails around infectious disease research and foreign grants. But while the plan is unlikely to find support among Democrats and certain patient advocacy groups, it previews some of the changes that President Trump could champion if he is elected to a second term. And with congressional frustration brewing since the pandemic, medical research advocates are not entirely dismissing reform in Bethesda, Md., where NIH is located.

“‘Overall, I see the broader point. The bigger picture is this is the kind of discussion the White House and Congress need to be having,” said Stuart Buck, director of The Good Science Project, which has advocated for reforms since 2022, but was not involved in the House-proposed plan.

The proposal from Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) is the latest in an onslaught of Republican demands for NIH reform and scrutiny. Sen. Bill Cassidy, the highest ranking Republican on the chamber’s health committee, last month issued a whitepaper laying out his reform priorities, including more transparency around research grants, auditing and reviews. A House select subcommittee on the coronavirus has held a parade of hearings questioning the agency’s oversight of infectious disease research and officials’ role in the Covid-19 response. Roger Severino, a former Trump health official, recommended probing conflicts of interests and introducing director limits in a conservative think tank’s plans for Trump’s reelection.

“The NIH monopoly on directing research should be broken,” Severino wrote.

That sweeping changes could find traction shows how once-bipartisan goals for NIH have splintered in the wake of the coronavirus pandemic and leadership shakeups.

Longtime NIH Director Francis Collins, who oversaw the agency through roughly $11 billion in funding boosts and positive relationships with both parties’ committee leaders, departed in 2021. The agency went without a permanent director for roughly two years, until senators confirmed Monica Bertagnolli last November.

This spring, after a lengthy battle, Congress authorized $48 billion for NIH, the agency’s first flat budget in years. Robert Aderholt, chair of the House Appropriations health subcommittee, signaled Friday that NIH could see some of these reforms as soon as this year’s budget cycle.

“The House Appropriations Committee will begin reflecting some of the applicable reforms as part of its fiscal year 2025 government funding process,” the Alabama congressman co-wrote with Rodgers in the STAT opinion piece.

Detractors say several of the proposed changes — particularly more grant reports and oversight — may cost the agency and researchers more money.

“I don’t think anybody would question, or should question that the NIH can be made better, but I don’t think this is the right approach,” said Nancy Andrews, chief scientific officer at Boston Children’s Hospital and longtime member of a review board designed to make NIH more efficient. “I don’t think Congress has the expertise to micromanage science funding.”

That said, Andrews told STAT that she could get beside certain changes, such as term limits for the directors of NIH centers.

Andrews and several disease research advocates also told STAT they could see the argument for combining certain institutes, particularly fusing the alcohol and drug misuse centers, as the scientific review board recommended in 2010. The merger never went forward, and the board has not met in years.

That proposal’s failure more than a decade ago demonstrates how much blowback a broad restructuring could face, particularly from patient advocacy groups that would see their disease areas — from diabetes to heart disease to skin ailments — subsumed into a broader National Institute on Body Systems Research.

“Taking a 27-institute organization down to 15 risks doing some damage,” said George Vradenburg, the chairman and co-founder of UsAgainstAlzheimer’s.

Vradenburg and other brain health advocates find themselves in an opposite quandary: Their areas of interest are split into three institutes. The proposal would rename the National Institute on Aging to the National Institute on Dementia, retain the National Institute of Mental Health and fuse three other centers under a “neuroscience and brain development” umbrella.

“Brain health is a life course issue,” said Vradenberg. “To disaggregate that is just going to create separate silos.” (Silos are exactly what House Republicans said they are trying to remove with this plan, in part by requiring biennial reports from every institute).

Advocacy groups are also adamant that the NIH’s newest agency, the multibillion-dollar Advanced Research Projects Agency for Health — remain untouched. Dozens of organizations pushed for the Pentagon-inspired health agency to be wholly independent of NIH; the House proposal would lump the agency with three other institutes in a new entity.

But Aderholt, at least, has expressed concern for some time that ARPA-H has seen funding increases without much oversight.

“Basic biomedical research at the NIH is essentially flat-funded, while the new ARPA-H… is proposed for a billion-dollar increase,” he said during a budget hearing in 2023. The proposal would reverse the $1 billion increase and distribute the funds among other institutes.

Committee aides told reporters Friday that they are open to working with advocates to modify or even scratch some proposals. They are asking for feedback through August, when Congress will return for a crowded fall legislative agenda.

If Congress takes action on any of these proposed changes, it would be the first major reform of the agency since 2006, when President George W. Bush signed a law that required NIH to establish a scientific review board and send biennial updates to Congress, but also introduced new research flexibilities like demonstration programs.

That legislation overwhelmingly passed with unanimous consent in the Senate and just four “no” votes in the House. But the landscape is markedly different today.

“If [E&C Chair Rodger] and Aderholt bring in some prominent Democrats and say, ‘let’s do this together, then there’s a possibility,” said Vradenburg. “I hate to see it politicized.”