Senate Confirms Makary, Bhattacharya as US FDA, NIH Leaders

President Donald Trump’s pick to lead the US Food and Drug Administration (FDA) won the backing of three Senate Democrats on Tuesday, while his nominee to lead the National Institutes of Health (NIH) was confirmed in a party line vote.

The Senate voted 56-44 to confirm Martin “Marty” Makary, MD, MPH, of Johns Hopkins University, as FDA commissioner. Senators voted 53-47 to confirm Jayanta “Jay” Bhattacharya, MD, PhD, of Stanford University, as NIH director.

Both physicians advocated for easing restrictions on gatherings during the COVID-19 pandemic, prompting criticism from some public health experts. 

Makary and Bhattacharya also openly criticized the organizations they will now lead. 

Makary in a 2021 Fox News opinion article called for new FDA leadership, critiquing both what he saw as flaws in the COVID response and the agency’s responsibility for “helping spawn the U.S. opioid crisis.” 

Bhattacharya earlier had criticized NIH for tilting toward more established science in general in its funding decisions. He was an author of a 2020 paper in the Proceedings of the National Academy of Sciences of the United States of America, which recapped a broad review of biomedical research studies.

“We find that in the current funding environment, there is a time lag for NIH funding of contributions that rely on new ideas,” Bhattacharya and co-authors wrote. “The NIH funds work that builds on very recent ideas at a lower rate than work that builds on ideas that have had a chance to mature for at least 7 [years].”

A health economist, Bhattacharya drew national attention — and harsh criticism from mainstream public health experts — as one of the primary authors of the Great Barrington Declaration, a COVID-19 pandemic document that excoriated lockdown policies and promoted “herd immunity” while protecting older people at greater risk from the disease. 

Makary: Patient Safety Researcher

A surgeon and public policy researcher at Johns Hopkins University, Makary long has published work with an emphasis on patients’ safety and wellbeing, including their finances. 

For example, his 2019 book, “The Price We Pay – What Broke American Health Care and How To Fix It,” includes details of research done by Makary and his team to study how often hospitals went to court to collect payments for what seemed to be inflated bills for services. 

“Keep in mind that most hospitals that sue patients are not shaking people down for fair market prices,” Makary wrote. 

He added later: “Hospitals warn patients with dozens of signs about X-ray radiation all over the radiology area. I wish these hospitals would warn patients about being sued with the same level of concern: WARNING: HOSPITAL LIKELY TO SUE.”

In his 2024 book, “Blind Spots: When Medicine Gets It Wrong, and What It Means for Our Health,” Makary argued for a broader approach to treating chronic diseases: “For example, can we treat Type 2 diabetes with cooking classes instead of just prescribing insulin?”

He told the Senate’s Health, Education, Labor and Pensions (HELP) Committee during a March 6 hearing that much of his research focuses “on the fundamental question: Is what we are doing working?”

Among the challenges Makary will face in leading the FDA will be some conservatives’ calls to more strictly regulate mifepristone. 

At the hearing, Sen. Patty Murray of Washington was among the Democrats who noted the existing body of research showing mifepristone to be a safe and effective medication, including a 2018 report from the National Academies of Sciences, Engineering, and Medicine.

“FDA does play a really critical role in making sure we have safe and effective medications,” Murray said, adding that there were “mountains of high-quality evidence and expert scientific judgment” about the safety of contraceptives and abortion medications.

“If you are confirmed, will you commit to upholding the science and evidence-based drug approvals for all FDA-approved products, including contraception and medication abortion?” Murray asked Makary.

“You have my commitment to follow the independent scientific review process at the FDA, which is a tried and true process,” Makary said. “That is my commitment to you.”

Makary will face challenges over regulating the increasing use of artificial intelligence (AI) in medical products. 

Scott Gottlieb, MD, who served as Trump’s FDA commissioner in his first term, in a JAMA Forum article last year suggested changes in the agency’s approach to regulating AI-driven products. 

Makary on July 11 tweeted a link to this article, complimenting Gottlieb. 

In his tweet, Makary included this quote from Gottlieb: “The FDA’s traditional regulatory approach, which depends on the agency’s capacity to meticulously examine a product’s construction, might prove infeasible.”

Bhattacharya: Health Economist

In his March 5 hearing with the Senate HELP committee, Bhattacharya argued for the value of allowing dissent and the need for more checks and skepticism in research.

“NIH-supported science should be replicable, reproducible, and generalizable,” he said.

“Unfortunately, much modern biomedical science fails this basic test.”

Bhattacharya cited as an example a recent scandal involving research on Alzheimer’s disease. A Medscape story last year reported that researchers say fraud and misconduct continue apace in Alzheimer’s research, undermining progress in understanding and treating the disease.

“If the data generated by scientists is not reliable, the products of such science cannot help anyone,” Bhattacharya told the HELP committee. “It is no stretch to think that the slow progress on Alzheimer’s disease is linked to this problem.”

The chairman of the Senate HELP Committee, Sen. Bill Cassidy (R-LA), MD, pressed Bhattacharya on the issue of measles vaccines and autism, urging him to preserve the limited funds available for studying pressing medical issues such as chronic disease.

Cassidy noted that the infamous Lancet article that sparked concern about a possible link had been retracted. The issue of a link between autism and the measles vaccines has been “exhaustively studied,” with findings supporting the vaccine’s use, he said 

“It’s a tragedy that a child would die from a vaccine preventable disease,” Bhattacharya told Cassidy. “I fully support children being vaccinated for diseases like measles that can be prevented with the vaccination effort.”

Cassidy pressed Bhattacharya on this point.

“Do you have an idea, an agenda, that would, once more — by golly, once more — prove that measles vaccine is not associated with autism?” Cassidy asked. “Because my concern is, the more we pretend like this is an issue, the more we will have children dying from vaccine-preventable diseases.”

“Will we once more have to go back over this particular issue? Because that has been exhaustively studied.” Cassidy added.

Bhattacharya said he didn’t think there was a link between the MMR vaccine and autism. 

Kerry Dooley Young is a freelance journalist based in Washington, D.C. She has reported on medical research and health policy for more than 20 years.