NIH advisers react to GOP plans

Nov 14, 2024

By Erin Schumaker, Daniel Payne, Carmen Paun and Ruth Reader

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WASHINGTON WATCH

NIH Director Monica Bertagnolli

NIH Director Monica Bertagnolli could be out of a job in January if President-elect Donald Trump wants to replace her. | Kevin Dietsch/Getty Images

Members of the NIH’s recently reconstituted scientific management review board had strong reactions to congressional Republicans' proposals to overhaul the agency, calling them “depressing” and “alarming” during the board’s meeting this week — the first in nearly a decade.

Congress created the board in the 2006 NIH Reform Act, charging it with reviewing the NIH’s structure and research portfolio and making recommendations to the NIH director.

Dr. Andrea Hayes Dixon, chair of the board and dean of Howard University’s College of Medicine, said the agency needs to reestablish trust and improve communication with the GOP lawmakers who want to subject the NIH to more oversight, consolidate its bureaucracy and rein in its funding.

“I think that’s even more evident in the comments that the senators and the congressmen made,” she said, referring to House and Senate Republicans' NIH reform proposals. “We were all in the room sort of scratching our heads, like, how could they possibly think that?”

Reconstituting the review board was a key part of the GOP proposals released earlier this year by Sen. Bill Cassidy (R-La.), ranking member of the Senate Health, Education, Labor and Pensions Committee, and Rep. Cathy McMorris Rodgers (R-Wash.), chair of the House Energy and Commerce Committee.

Cassidy is likely to become the HELP chair in January. Rodgers is retiring from Congress, but her successor on the Energy and Commerce panel is expected to continue her push.

The board fell dormant under former NIH Director Francis Collins, sparking criticism from House and Senate Republicans interested in increasing NIH oversight. The 2024 omnibus appropriations law includes a directive to restart it.

HHS Secretary Xavier Becerra appointed members in September.

NIH Director Monica Bertagnolli, whom President-elect Donald Trump could replace, didn’t discuss the high-stakes environment during her opening remarks at the board meeting, instead asking the members to investigate how the agency could improve collaboration, data-sharing, assistance to underserved communities and public trust.

What’s next? Rodgers’ plan to impose five-year term limits for NIH directors and consolidate its 27 centers to 15 is part of the House version of the as-yet-unresolved bill to fund the agency in fiscal 2025.

Whoever Trump chooses to run HHS could replace the board’s members.

Robert F. Kennedy Jr., the anti-vaccine activist and Trump adviser, says he wants to fire hundreds of NIH staffers, although it’s unclear how he would do that given their civil service protections.

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ON THE HILL

Independent presidential candidate Robert F. Kennedy Jr. speaks at a campaign event.

Robert F. Kennedy Jr. acolytes are heading to Capitol Hill next week.' | Mario Tama/Getty Images

Advocates for Robert F. Kennedy Jr.’s Make America Healthy Again movement will brief congressional health staffers Wednesday on the MAHA policy vision, our Brittany Gibson and Daniel report.

Kennedy and his allies want to fire government regulators, crack down on pesticides and food additives, halt fluoridation of drinking water and examine the safety data for vaccines, among other far-reaching changes to the public health system.

Jeff Hutt, spokesperson for the Make America Healthy Again PAC and former national field director for Kennedy’s presidential campaign, will speak with staffers on Capitol Hill. The meeting follows a similar briefing in September from Calley Means, a former food-industry lobbyist who has become a prominent voice in the debate over President-elect Donald Trump’s health policy platform.

Why it matters: Trump told Kennedy he’d allow him to oversee the government’s health agencies.

Hutt has said MAHA allies are working with the Trump transition team to vet potential nominees for the incoming administration — though the Trump team declined to comment on their involvement.

What’s next? Trump still has to name key appointees to health agencies starting with the Department of Health and Human Services, which includes agencies Kennedy wants to overhaul, such as the Food and Drug Administration, the National Institutes of Health and the Centers for Disease Control and Prevention.

The lame duck session could reshape major policies before year's end. Get Inside Congress delivered daily to follow the final sprint of dealmaking on defense funding, AI regulation and disaster aid. Subscribe now.

POLICY PUZZLE

A laboratory technician examines sickle cell blood samples, at the Mbale Regional Referral Hospital in Mbale, Uganda, Wednesday, April 24, 2024. There can be lifelong challenges for people with sickle cell disease in rural Uganda, where it remains poorly understood. (AP Photo/Hajarah Nalwadda)

Gene therapy offers a potential cure for people with sickle cell disease, but it's expensive. | AP

Costs and regulatory hurdles are holding up the development of gene-editing therapies, according to a new report from the Government Accountability Office, the watchdog arm of Congress.

Gene-editing allows scientists to knock-out genes linked to diseases. These therapies are tightly restricted by the Food and Drug Administration and there are limits on National Institutes of Health funding.

So far, the FDA has only approved gene-editing therapies for sickle-cell disease, a rare and painful condition marked by misshapen blood cells, and beta thalassemia, which lowers blood cell production. The treatments are expensive, starting at $2.2 million, and physically debilitating for patients. Companies are concerned there won’t be a return on investment.

Gene-editing treatments will likely continue to be expensive, the report says. It’s not clear if insurance will cover them.

The report says the FDA should consider streamlining its process for approving gene-editing therapies. The agency is already in the process of doing so. Earlier this year, the FDA released draft guidance explaining to companies how they can augment an overarching treatment platform to treat a variety of diseases.

It also calls for policymakers to create payment structures that help patients afford the cost of care. The Centers for Medicare and Medicaid Services announced a pilot to increase access to gene-editing therapy for people with sickle cell disease in response to President Joe Biden’s executive order on lowering prescription drug costs. It will begin enrolling patients in 2025.

While the U.S. reforms its rules, China, which has fewer restrictions around gene-editing research, is investing heavily in the technology. Last month, two Chinese companies started gene-editing clinical trials for muscular dystrophy.

Policy change is coming—be the pro who saw it first. Access POLITICO Pro’s Issue Analysis series on what the transition means for agriculture, defense, health care, tech, and more. Strengthen your strategy.