He repeatedly assured Republican and Democratic senators he would follow the "scientific process" at FDA. But he wouldn't commit to specific actions on a host of hot-button issues, including the abortion pill mifepristone, which has been ensnared in politics since a 2021 decision by FDA making it available by mail.
“I have no preconceived plans on mifepristone policy except to take a hard look at the data and to meet with the professional career scientists at the FDA who have reviewed the data,” Makary told Sen. Bill Cassidy, the Louisiana Republican who chairs the health committee.
Makary's remarks echoed those of Health Secretary Robert F. Kennedy, who told lawmakers in January he wants to "study" the safety of mifepristone and a host of other long-established therapies, including antidepressants, childhood vaccines and attention-deficit drugs. The prospect of Trump officials overturning the approval of FDA-approved medicines is a growing concern for physicians, medical researchers and drugmakers.
Mifepristone was approved roughly 25 years ago and FDA scientists have repeatedly reaffirmed its safety over the years, easing limits on its use, including eliminating a requirement that patients pick it up in person. The FDA has been facing pressure from anti-abortion groups and lawmakers to restrict mifepristone following legal battles over access.
Like other drugs, the FDA continues to collect reports of side effects and complications with the pill. Makary said he wouldn’t “prejudge the data without seeing it.”
That idea didn’t reassure Sen. Maggie Hassan, one of several Democrats who pressed Makary to commit to keeping the drug available under its current framework, which allows online prescribing by health professionals.
“The concern is whether you are going to unilaterally overrule the data that currently exists for political purposes," the New Hampshire senator said, after referring to dozens of studies supporting the drug's safe use. “We need to know when you say that you’re an independent scientist, that’s what you really mean.”
FDA commissioners aren’t typically involved in the agency’s day-to-day medical reviews, but they often serve as a buffer between FDA scientists and political forces elsewhere in government.
If confirmed, Makary would take over at a particularly turbulent period for the agency. Last month, the FDA abruptly fired hundreds of staffers across multiple parts of the agency, only to rehire some of them a week later. The agency's top food regulator and several other senior leaders have resigned or retired in recent weeks.
Makary told lawmakers he was "not involved” in any of the recent staff reductions and would do his own assessment on whether some employees should be rehired.
Similarly, Makary said he had no involvement in FDA’s recent decision to abruptly cancel a meeting of outside vaccine experts who were scheduled to make recommendations for next season’s flu shots. He downplayed the significance of the meeting and wouldn't commit to rescheduling it, noting that in previous years the FDA panel “rubber-stamped” recommendations made by international vaccine authorities.
As commissioner, Makary said he would “reevaluate” which vaccine topics merit consulting the agency's outside advisers.
Trump administration officials said FDA’s staff scientists will choose strains for the shots and send them to manufacturers, ensuring that updated vaccines are ready for the fall.
“What is lost is the transparency,” said Cassidy, who noted that eliminating the public meeting cuts against Kennedy’s pledge for “radical transparency" in health decisions. “We want the American people to know, and obviously canceling the meeting shuts the door a little bit."
The cancellation marked the second time in less than a week that the Trump administration intervened in a previously scheduled vaccine meeting. A late February meeting of the Centers for Disease Control and Prevention's vaccine advisory panel has been postponed, with no new date set.
Kennedy recently called for a "Make America Healthy Again" commission to review the safety of a number of FDA-approved products, including vaccines, weight-loss drugs and stimulants. Given Kennedy's history of spreading discredited fears about vaccines, health groups and Democratic lawmakers have warned that he could appoint new experts who share his beliefs to FDA's vaccine advisory panel.
Again, Makary said he has “no preconceived plans to rearrange that committee or any committee,” and he defended Kennedy’s efforts: “Secretary Kennedy wants to make America healthy again.”
Makary emphasized his support for Kennedy's “MAHA agenda,” particularly on food, where he said additives, colorings and other chemicals could be contributing to chronic health problems.
“These are chemicals that the industry insists are safe — a subset of which are concerning,” Makary told Alabama Republican Sen. Tommy Tuberville “We have to look at those ingredients, and you have my commitment to do so if confirmed."
Compared with Kennedy, Makary is considered one of Trump’s more conventional health nominees and is widely expected to be confirmed. A full Senate vote on his nomination is expected in the coming weeks.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
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