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March 26, 2025
by Ferdous Al-Faruque

Senate confirms Makary and Bhattacharya to lead FDA, NIH

The US Senate has confirmed President Donald Trump’s nominees to lead the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) in two votes split largely down party lines.
 
On Tuesday night, senators voted 56 to 44 and 53 to 47 to confirm Martin Makary as FDA commissioner and Jay Bhattacharya as NIH director, respectively. While Bhattacharya’s vote was purely down party lines, three Democratic senators, Dick Durbin (D-IL), Maggie Hassan (D-NH), and Jeanne Shaheen (D-NH), crossed the aisle to vote for Makary.
 
Makary and Bhattacharya’s nominations were advanced out of the Senate Health, Education, Labor, and Pensions (HELP) committee on 13 March. At the time, Hassan and Sen. John Hickenlooper (D-CO) voted with Republicans to forward Makary’s nomination, though Hickenlooper ultimately voted against his confirmation on the Senate floor. (RELATED: Senate committee advances Makary nomination, Regulatory Focus 13 March 2025)
 
Once sworn in, Makary and Bhattacharya will helm agencies that have been under significant stress for the past few months. The Trump administration has fired thousands of workers across the Department of Health and Human Services (HHS), and staff have been ordered to return to office (RTO) despite the lack of office space and other resources. (RELATED: Some FDA staff considering quitting due to Trump’s RTO policy, Regulatory Focus 19 March 2025)
 
During their confirmation hearings, Makary and Bhattacharya denied having any input into the administration’s decision to fire staff en masse. Makary said he would evaluate FDA’s staffing needs after being appointed FDA commissioner to ensure the agency has the resources it needs to accomplish its mission. (RELATED: Makary commits to review FDA staff cuts, VRBPAC cancelation in Senate confirmation hearing, Regulatory Focus 6 March 2025)
 
Makary, a Johns Hopkins surgeon, committed to reevaluating the decision to cancel the recent Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to evaluate the influenza vaccine strain composition for the 2025-2026 flu season with leadership at the Center for Biologics Evaluation and Research (CBER). He also said he would evaluate the clinical trial diversity guidance that the Trump administration had recently removed from the FDA’s website but was forced to republish.
 
AdvaMed CEO Scott Whitaker congratulated Makary on his confirmation on LinkedIn.
 
“We look forward to working with him and his leadership team on two shared goals,” said the head of the medtech lobby group. “First, to advance the administration’s ‘Make America Healthy Again’ agenda, which is at the heart of what our companies do day in, day out. And second, to ensure FDA remains the global gold standard for its rigorous medical device safety and efficacy standards. An efficient, transparent FDA is key to both goals.”
 
During his confirmation hearing, Bhattacharya pledged to implement five goals after being confirmed as NIH director, including establishing a culture of respect for free speech in science and scientific dissent. The Stanford professor said he would focus NIH research on solving the chronic disease crisis and recommit to its mission to fund the most innovative biomedical research agenda possible to improve American health. He also said he wants to focus funding on issues such as population aging and obesity. (RELATED: This Week at FDA: Nomination hearings, FDA lease cancellations, and more, Regulatory Focus 7 March 2025)
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