Makary commits to review FDA staff cuts, VRBPAC cancelation in Senate confirmation hearing

Martin Makary, President Donald Trump’s nominee to lead the US Food and Drug Administration (FDA), committed to investigating several controversial issues, including access to mifepristone, a canceled advisory committee meeting, the agency’s personnel needs, and a recent clinical trial diversity guidance.

Makary, a Johns Hopkins surgeon, faced questions from lawmakers on the Senate Health, Education, Labor and Pensions (HELP) committee on 6 March. Committee Chair Bill Cassidy (R-LA) and other lawmakers asked him whether, if confirmed, he would reinstate in-person prescribing and adverse event reporting requirements for the abortion drug mifepristone. Under the Biden administration, FDA lifted in-person prescribing requirement and enabled the drug to be mailed to patients.

Makary said he had no preconceived plan to change how mifepristone is regulated and said he would investigate the matter without making a firm commitment to maintaining access to the drug or restricting it beyond current measures.

“My position is that of a scientist,” said Makary. “As you know, part of the [risk evaluation and mitigation strategy (REMS)] … requires ongoing data collection, so I can’t prejudge that data without looking at it.”

“I would convene the scientists that are professional career scientists at FDA who have reviewed the totality of data on this and are also looking at ongoing data that is being collected,” he added. “There could be … a drug-drug interaction that may show up on the ongoing data.”

Cassidy and other senators raised concerns about FDA’s recent decision to cancel the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to evaluate the influenza vaccine strain composition for the 2025-2026 flu season. He noted that Health and Human Services (HHS) Secretary Robert Kennedy Jr. had assured him that he would not interfere with the agency’s vaccine work and would provide more transparency, but the meeting cancellation “seems to go backward on that.” (RELATED: Flu vaccine advisory committee meeting cancellation raises concerns about HHS’ future, Regulatory Focus 27 February 2025)

Sen. Patty Murray (D-WA) pressed Makary on whether he would reschedule the meeting.

Makary said he would reevaluate the decision to cancel the meeting with the leadership at the Center for Biologics Evaluation and Research (CBER) but wouldn’t commit to reinstating it. He also noted that the advisory committee has adopted recommendations from the World Health Organization’s (WHO) Global Influenza Program (GIP) for the past seven years he’s been following the committee’s actions.

“In conjunction with the center director of the biologics center, I would reevaluate which topics deserve a convening of the advisory committee members on VRBPAC, and which may not require a convening,” said Makary.

“I have no preconceived plans” to remove members from advisory committees, he added.

The Trump administration last month fired thousands of probationary workers across federal agencies, including hundreds at FDA. The administration has since rescinded some of the terminations following pressure from the healthcare product industry and other stakeholders.

Several senators, including Sens. Susan Collins (R-ME) and John Hickenlooper (D-CO), asked Makary about the personnel and other cuts at FDA. Makary committed to conducting an assessment of the agency’s personnel needs to ensure that staff have all the resources they need to do their jobs. (RELATED: FDA rehires some laid-off staff, though some fear lasting damage to trust, Regulatory Focus 24 February 2025)

Sen. Tim Kaine (D-VA) asked if Makary supported the way the layoffs were conducted. Makary did not answer directly but said he was open to the idea of making government more efficient.

Sen. Lisa Blunt Rochester (D-DE) asked Makary whether clinical trial diversity is important and, if so, whether 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. Makary said he wants to take a common sense approach to the agency’s work and committed to looking at the guidance.

"I believe in common sense, and I believe in clinical trial diversity both,” said Makary. “I believe that if you're going to make results extrapolated to the general population you should have results in those populations that you're making recommendations for."

Blunt Rochester also raised concerns about medical misinformation and disinformation, which was a key concern for former FDA Commissioner Robert Califf. She asked Makary how he would use his position at FDA to address uninformed voices and share evidence-based consensus information that is free from political influence. Makary said he believes in empowering people with the best information and that's why he's written three best-selling books on health.

"You can explain to people with humility what we know and what we don't know, and then they're going to trust us more,” said Makary. “Trust in doctors and hospitals is at a crisis right now.”

“I do not believe in censorship of scientific opinions,” he added. “I think we need a civil discourse. Unfortunately, we have a sort of toxic discourse right now in the United States in the politicization of immune cells in some cases."

Sen. Andy Kim (D-NJ) asked Makary about his thoughts on HHS’ recent decision to waive public comment requirements in certain rulemaking situations that largely apply to personnel matters, grants, and other administrative issues. Makary noted that there are laws that govern regulations regarding public comments, but he is generally for more civil discourse.

“I do believe in civil discourse and have been an advocate for civil discourse, coming out of an era of medical establishment censorship, so I do believe in the principle,” he said.

Sen. Lisa Murkowski asked Makary about finding treatments for ALS and how he planned to apply common sense to the FDA’s regulatory decisions. Makary said the regulatory process has to be customized to the condition under consideration. He said it's not possible to require two randomized controlled trials for a condition that only affects a handful of people.

"I do believe firmly in that approach, and I think we can use some common sense to ask some big questions we've never asked before at the FDA,” said Makary.

More specifically, Makary said regulators need to ask questions such as why a drug should require a prescription if it can be sold over the counter and why products such as continuous glucose meters (CGM) need to be prescribed by physicians when they can be used by anyone to potentially prevent pre-diabetes.

“Why are we holding these tools that help people to empower them with knowledge about their health until after they're sick,” said Makary.

Makary commits to review FDA staff cuts, VRBPAC cancelation in Senate confirmation hearing

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