FDA nominee Marty Makary tells HELP Committee he will review mifepristone data, reassess canceled vaccine advisory meeting and assess staffing

Dr. Marty Makary, President Trump’s nominee for commissioner of the Food and Drug Administration, told the Senate Health, Education, Labor and Pensions Committee during his confirmation hearing that he will “follow the independent scientific review process at the FDA” and pledged several near-term reviews if confirmed.

Makary told Chairman Bill Cassidy and members of the committee that he would review ongoing data collected under REMS (Risk Evaluation and Mitigation Strategy) for mifepristone and has “no preconceived plans to make changes” to current policy. He said he would meet with career scientists at FDA and consider convening external experts where needed. “You have my commitment to follow the independent scientific review process at the FDA,” Makary said during a line of questioning about medication abortion and the REMS process.

Why it matters: The nominee’s answers touch on several high-profile issues — access to medication abortion, transparency of vaccine advisory processes, agency staffing, and conflicts of interest — that shape public health regulation and public trust in federal health agencies.

Key commitments and exchanges - Mifepristone and REMS: Makary said he would review the full body of data collected under the REMS program, including ongoing safety monitoring, and declined to pre-judge that evidence. He added he had “no preconceived plans to make changes to the mifepristone policy.” Several senators pressed him to state whether he would maintain current access; Makary emphasized that his approach would be data-driven and conducted in consultation with FDA career scientists.

- Vaccine advisory committee (VRBPAC) meeting: Committee members said FDA canceled an annual advisory meeting that traditionally reviews influenza strains. Makary said he had not been involved in that decision and pledged to “reevaluate which sessions…could benefit from convening the advisory committee” and to restore transparency where the committee’s expertise is needed. Senator Patty Murray and others asked for an immediate reconvening; Makary said he would evaluate the decision with center leadership.

- Agency staffing and recent federal layoffs: Senators pressed Makary on recent agency staffing reductions reported across federal agencies and at FDA. Makary said he was not involved in prior personnel decisions and committed, if confirmed, to conduct an assessment of staffing and personnel needs to ensure career scientists and inspectors have the resources required to do their work.

- Conflicts of interest and ethics: Makary said he completed an Office of Government Ethics review, that he chose voluntarily to divest and resign from private holdings, and that he would abide by OGE-required recusals. “I chose voluntarily to divest and resign from everything,” he said at the hearing.

- Drug pricing, generics and biosimilars: Makary said he supports measures to accelerate approval pathways for generics and biosimilars, including options to speed biosimilar review where competition is inadequate. He also discussed other approaches to lowering drug prices, such as moving certain products over the counter where appropriate.

- Food safety, vaping and children’s nutrition: Senators raised flavored e-cigarettes and…