Senate committee advances Makary nomination
In a 14-9 vote on Thursday, the Senate Health, Education, Labor, and Pensions (HELP) Committee advanced President Donald Trump’s pick to serve as US Food and Drug Administration (FDA) commissioner to the full senate for a vote.The vote comes one week after Martin Makary, a Johns Hopkins surgeon and author, appeared before the committee for his confirmation hearing. During the hearing, Senators on both sides of the aisle questioned Makary over his stance on the abortion drug mifepristone, FDA’s personnel needs, and a canceled meeting of the agency’s vaccine advisors, among other topics that extended to vaping and food standards. Sens. Maggie Hassan (D-NH) and John Hickenlooper (D-CO) joined the 12 Republican members of the committee to support Makary’s nomination.
Makary committed to reviewing those issues, though largely refrained from answering how he would handle them, insisting he would be heading to the agency with “no preconceived plans” to change how the agency regulated mifepristone or to remove certain members of the Vaccines and Related Biological Products Advisory Committee. (RELATED: Makary commits to review FDA staff cuts, VRBPAC cancelation in Senate confirmation hearing, Regulatory Focus 6 March 2025)
With Republicans in control of the Senate, Makary is widely expected to be confirmed as the next FDA commissioner. One Republican, Sen. Josh Hawley (R-MO), briefly expressed alarm at Makary’s apparent selection of Hilary Perkins – who defended access to mifepristone during the Biden administration – to serve as FDA’s chief counsel. Perkins’ appointment was announced on Tuesday, but as of Thursday morning FDA said she had resigned her position effective immediately. Hawley ultimately joined his Republican colleagues casting a vote for Makary.
“If confirmed as FDA Commissioner, Dr. Makary committed to promoting medical innovation while upholding FDA’s gold standard of review, so Americans can benefit from the latest lifesaving medicines and devices. He emphasized the need to address obesity and chronic disease, in collaboration with other administration officials,” said Committee Chair Bill Cassidy (R-LA).
“The FDA requires a commissioner who is willing to withstand pressure—from Big Pharma, Big Tobacco, or maybe even the President—to protect public health. We cannot afford an FDA Commissioner who gets chewed up by Elon Musk’s chainsaw or stands idly by as [Robert F. Kennedy] RFK Jr. pushes his deadly bias against vaccines. To safeguard and regulate the food we eat and the drugs we use, we need a leader at FDA with the courage to say ‘no,’” said Senate Minority Whip Dick Durbin (D-IL) after meeting with Makary earlier this week.
The HELP committee also voted to advance the nomination of Trump’s pick to lead the National Institutes of Health (NIH), Jay Bhattacharya, in a 12-11 party-line vote. (RELATED: This Week at FDA: Nomination hearings, FDA lease cancellations, and more, Regulatory Focus 7 March 2025)