NIH Chief Details Plans for FDA Modernization at Senate Hearing

 The NIH must be structurally overhauled to deliver more cures, spend taxpayer dollars more wisely, and regain public trust, NIH Director Jay Bhattacharya, MD, PhD, said Tuesday during a Senate hearing on modernizing the agency.

In the wide-ranging Senate Committee on Health, Education, Labor, and Pensions hearing, Bhattacharya outlined his plan to make NIH more accountable, better coordinated, and more focused on measurable impact for patients.

"Meaningful reforms that increase transparency, strength, and scientific rigor, and ensure accountability are necessary to bolster the NIH's ability to meet America's current and future public health needs," Bhattacharya said. "As science itself evolves, so too must the structures that support it."

Sen. Bill Cassidy, MD (R-La.), the committee's chair, broadly agreed about the need for reform but warned that modernization should not also destabilize the nation's premier biomedical research agency.

Noting that Congress typically revisits NIH policy roughly every decade -- citing the 2006 NIH Reform Act and the 2016 21st Century Cures Act -- Cassidy said the moment has arrived again. At the same time, he cautioned that recent funding cancellations by President Donald Trump's administration had rattled the research community and could weaken U.S. readiness for future pandemics.

"We must acknowledge recent actions at NIH have created uncertainty within the American research enterprise and potentially undermined the agency's ability to serve," he said.

Cassidy pointed to his 2024 white paper as a road map for reform, calling for changes to the grant review process to reward "more big ideas and fewer incremental experiments," better coordination between NIH's intramural scientists and university researchers, wider use of artificial intelligence to make both positive and negative study results accessible, and stronger oversight of foreign-funded research.

Bhattacharya emphasized reforms already underway at NIH, including centralized peer review to reduce duplication, a new analytic office in the Office of the Director to address the replication crisis, and a unified funding strategy to better align investments with national health priorities. He also called for stronger federal oversight to "ensure that NIH-funded research does not lead to significant adverse social consequences" and said portfolios under his leadership would be evaluated by their impact on disease and population health, not publication count.

"We also need to move the needle and incentivize high-risk, high-reward research," he said. Research "will be judged by their success at curing disease, improving population health, and creating fundamental scientific breakthroughs, rather than simply how many scientific papers each project yields," he added.

During questioning, senators pressed Bhattacharya on vaccines, funding cuts, and politicization of NIH.

Asked directly by Sen. Bernie Sanders (I-Vt.) whether vaccines cause autism, Bhattacharya replied, "I have not seen a study that suggests any single vaccine causes autism."

That led to an exchange between Cassidy and Bhattacharya about public trust in vaccines amid HHS Secretary Robert F. Kennedy Jr.'s skepticism. Cassidy warned of potential increases in meningococcal disease, for example, among the unvaccinated following changes to the CDC's childhood vaccination schedule. Clear, consistent education, he said, is essential to restore confidence.

"If you keep on telling people permutations of what is false, they don't know who to believe," Cassidy said.

Sen. Patty Murray (D-Wash.) said Trump administration funding cuts affected roughly one in 30 clinical trials and more than 74,000 participants. Bhattacharya said NIH renegotiated terms with investigators and ensured continuity of care for affected patients.

"Ultimately, we worked with researchers across the country to make sure the clinical trials were really focused on advancing health and not on other political agendas," Bhattacharya said.

Sen. Tammy Baldwin (D-Wisc.) challenged Bhattacharya on the increase in political appointees at NIH from two to 10.

Asked why so many were needed, Bhattacharya responded: "I think the key thing to me is to make sure the grant reviews that we do are not political."

Countered Baldwin: "And so having five times as many political appointees as before helps make that less political?"

https://www.medpagetoday.com/washington-watch/washington-watch/119722