Makary Sails Through Nomination Hearing for FDA Commissioner

Marty Makary, MD, MPH, President Trump’s nominee for FDA commissioner, seems likely to be a lock for the position if Thursday’s nomination hearing before the Senate Health, Education, Labor & Pensions (HELP) Committee is any indication.

“I’m so excited to see you here today,” Sen. Ashley Moody (R-Fla.), a member of the committee, told Makary. “I’m incredibly happy with your nomination. I know you’re going to do a great job.”

Committee Chair Sen. Bill Cassidy, MD (R-La.), also signaled his support for Makary, a surgical oncologist and medical researcher at Johns Hopkins University in Baltimore. “Americans’ trust in our public health and science agencies and the products they regulate must be restored,” Cassidy said in his opening statement. “Rebuilding public confidence in medical products like vaccines is especially important as we respond to measles outbreaks and as FDA considers recommendations for vaccines for flu strains ahead of the upcoming flu season. Dr. Makary, with his experience as a surgeon and an effective health policy communicator, can help our public health agencies rebuild trust with the American people.”

Concern About Meeting Cancellation

The issue of flu strain vaccine recommendations was one that came up repeatedly during the hearing; last week’s cancellation of a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) at which that issue was supposed to be discussed appeared to weigh heavily on the minds of some committee members, including Cassidy. “I’m told by people who are familiar that the FDA will … come up with the right decision, but they also say what is lost is the transparency, because the open meeting allows a postmortem, if you will,” Cassidy said.

“[It’s] a review of last year, what went right, what went wrong, and how to make it better,” he continued. “I think one of the laudable things about [HHS] Secretary [Robert F.] Kennedy’s positions is he wants more transparency in terms of how the federal government makes medical decisions as part of restoring that faith. And so frankly, this seemed to kind of go kind of backwards on that. So how will you ensure that advisory committees remain objective, transparent, and still benefiting from the necessary expertise of external experts?”

“I was not involved in that decision,” Makary said. “Once in office, you have my commitment to take a look at it. As you know, the VRBPAC committee takes a look at guidance and recommendations from international groups such as the [WHO’s Global Influenza Programme (GIP)]. My understanding is at least for the last 7 or 8 years that I’ve been following that group, we have simply rubber stamped whatever the GIP — “

Cassidy then interrupted him, noting that “since these strains typically begin in Australia or China, it isn’t so much as a rubber stamp, but as much as recognizing ‘what [strains] are you seeing?’ Because that’s what’s coming to us,” he said. “So I think it’s more than quibbling to say that you’re learning from them.”

Sen. Susan Collins (R-Maine) also expressed concern about the VRBPAC cancellation. “If you’re confirmed, will you reinstate the meetings of the committee?” she asked.

“VRBPAC will meet if I’m confirmed, yes,” said Makary, a former medical editor-in-chief of MedPage Today.

Mifepristone in the Spotlight

The regulation of the abortion medication mifepristone (Mifeprex) also came up at the hearing. Sen. Tammy Baldwin (D-Wisc.) said that when she and Makary met earlier in her office, “I thought that you were pretty clear with me during that meeting that you were aware of the overwhelming scientific conclusion about the safety of this medication, and that you did not think politics should be involved in decisions moving forward. And I understood from our conversation that you intended to stand behind the FDA’s long-standing determination” that the drug was safe.

“But after our meeting — I don’t know if it was you or your minders — but they followed up with my staff and said they felt that you misunderstood my question and wanted to clarify your answer, which, by my read, implied that you are open to totally re-examining the scientific determination, even with decades of evidence,” she continued. “So I want to clearly understand your position: as FDA commissioner, will you maintain current access to mifepristone? Yes or no.”

Makary did not answer her directly, but instead referred back to the risk evaluation and mitigation strategy (REMS) for ensuring the safety of mifepristone. “My position is that of a scientist — as you know, part of the REMS that was put in, initially by President Clinton in that administration, and then modified under Obama, and then again, under President Biden, requires ongoing data collection, so I can’t pre-judge that data without looking at it,” he said, adding that he would “convene the professional career scientists at the FDA, who have reviewed the totality of data on this and are also looking at ongoing data … There could be, for example, a drug-drug interaction that may show up on the data.”

Baldwin seemed clearly unhappy with that answer. “If that’s your approach to something that has been approved for decades, are you going to do the same with Tylenol?” she said. “There are a lot of side effects for daily use, including liver damage.”

Makary also did not answer directly when Sen. Josh Hawley (R-Mo.) asked him whether he would reinstate an earlier FDA requirement that mifepristone be prescribed over the course of three in-person visits. “I do think it makes sense to review the totality of data and ongoing data,” he said. “I know personally of [ob/gyns] who prefer to insist — even though they have the option to prescribe otherwise — that mifepristone be taken when necessary in their office as they observe the person taking it. And I think their concern there is that if this drug is in the wrong hands, it could be used for coercion.”

Question About FDA Workforce

Sen. Angela Alsobrooks (D-Md.), whose state includes many recently fired federal employees, asked Makary what he would do regarding the FDA workforce. “Many of the actions of this administration have been quite chaotic and confusing,” she said, noting that the Office of Personnel Management had issued a memo “direct[ing] agencies to dramatically reduce staff, and then they reversed themselves … by saying that decisions to fire should be left to individual agencies. And so I’d like to ask you, given this updated guidance, whether we have your assurance here today at this hearing that you will not arbitrarily fire employees at FDA.”

“I’m a big believer in the professional career staff at the FDA,” said Makary. “You have my promise that if confirmed, I will do my own independent assessment on personnel. I welcome input on efficiencies at the agency, but at the same time, I want to make sure that the scientists and food inspectors and staff central to the core mission of the agency have all the resources they need to do their job well.”

Sen. Bernie Sanders (I-Vt.), the committee’s ranking member, was notable by his absence from the hearing. In response to an emailed question, a Sanders spokesperson referred MedPage Today to remarks Sanders made during a committee session that occurred immediately prior to Makary’s appearance.

“Truthfully, and with respect to Dr. Makary, it does not matter who the next FDA commissioner is,” Sanders said. “I think everybody on this committee and the people of America understand who is running the government, and it’s not going to be the Secretary of Labor. It’s not going to be the commissioner of the FDA. With all due respect to President Trump’s nominees, the person who is running the government right now is Elon Musk.”

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