Health Care

Key takeaways from Marty Makary’s FDA confirmation hearing

Marty Makary, a career surgeon and President Trump’s nominee to run the Food and Drug Administration (FDA), faced senators in his confirmation hearing on Thursday, aligning himself with the Make America Healthy Again agenda but stopping short of outright endorsing some recent, controversial decisions.

Makary’s hearing before the Senate Health, Education, Labor and Pensions Committee, like the hearing for Jay Bhattacharya for the National Institutes of Health the day before, was relatively tame, especially compared to the confirmation process of Health and Human Services Secretary Robert Kennedy Jr.

A public policy researcher and professor at Johns Hopkins University, Makary was a prominent skeptic of COVID-19 lockdowns and frequently appeared on Fox News during the pandemic. He leaned on his career in research when making his case before the committee.

“I believe in the scientific process. In addition, I also believe that we can use common sense,” Makary said in his opening remarks. “President Trump and Secretary Kennedy’s focus on healthy foods has galvanized a grassroots movement in America. Childhood obesity is not a willpower problem, and the rise of early-onset Alzheimer’s is not a genetic cause. We should be and we will be addressing food as it impacts our health.”

Democrats hammered Makary on recent moves by the Trump administration to cut FDA staff and pressed him on plans to exercise his authority over drugs such as the abortion pill mifepristone.

Ranking Member Bernie Sanders (I-Vt.) left before the question portion of the hearing began, but said in his remarks that “it does not matter who the next FDA commissioner is. I think everybody on this committee and the people of America understand who is running the government,” referring to Elon Musk.

Here are three key takeaways from the hearing:

Makary says he will resume vaccine committee meetings

Since Kennedy was confirmed as HHS secretary, the FDA abruptly cancelled a meeting dedicated to discussing the next influenza vaccine strains, without any given reason.

HELP Committee Chair Bill Cassidy (R-La.) lamented this development, saying it went “backwards” on Kennedy’s promises of transparency. Cassidy asked Makary how he would ensure transparency if confirmed as FDA commissioner.

“I was not involved in that decision. Certainly, if confirmed, once in office, you have my commitment to take a look at it. As you know that [Vaccines and Related Biological Products Advisory Committee (VRBPAC)] takes a look at guidance and recommendations from international groups such as the [Global Influenza Programme] International Consortium,” Makary said.

The FDA nominee, however, appeared to take issue with the influence that the World Health Organization’s Global Influenza Programme has on the U.S.’s flu vaccine policy, speaking in favor of U.S. independence from such international groups.

When pressed by senators on both sides of the aisle on the canceled meeting, Makary repeatedly distanced himself, stating he was not involved in that decision.

Republican Sen. Susan Collins (Maine) asked if he would reconvene the VRBPAC meeting if confirmed, to which he said, “The VRBPAC committee will be meeting if confirmed and I’m commissioner, yes.”

Commits to ‘independent scientific review’ of key abortion drug

If confirmed, Makary stands to have enormous influence over access to drugs in the U.S. including the mifepristone, one of two drugs commonly taken for medical abortions.

According to Sen. Tammy Baldwin (D-Wis.), Makary had said in a meeting in her office that he was “clear” on the “overwhelming scientific conclusion about the safety of this medication.”

He did not confirm these remarks on Thursday, instead responding that the FDA’s risk evaluation and mitigation strategy “requires ongoing data collection” and that he wouldn’t prejudge the data before looking at it.

Specifically citing mifepristone, which was approved for use in abortions in 2000, Sen. Patty Murray (D-Wash.) asked Makary if he would commit to upholding “science and evidence-based drug approvals for all FDA approved products.”

“Sen. Murray, you have my commitment to come to follow the independent scientific review process at the FDA, which is a tried-and-true process and that has been around, and so that is my commitment to you,” Makary said.

Sen. Maggie Hassan (D-N.H.) doubled down on the issue, challenging Makary on his claim that he will remain an “independent scientist” amid heightened political rhetoric on abortion.

“I have no preconceived plans to make changes to the mifepristone policy,” Makary told Hassan, though he speculated there may be unidentified drug interactions that the FDA could identify in the future.

‘Happy to look’ at rehiring fired FDA employees

As with the decision to cancel the FDA’s flu vaccine meeting, Makary also distanced himself from the recent department layoffs, repeating that he was not involved in those decisions.

FDA employees were among thousands of probationary workers fired from the HHS last month, however, some employees overseeing areas including medical devices and food ingredients were hired back days later.

Collins noted that many FDA employees are not paid with taxpayer dollars, their salaries instead funded through user fee agreements.

Makary stated he would conduct an “assessment of the staffing and personnel at the agency.”

He gave a similar response to Sen. Angela Alsobrooks (D-Md.) when she directly asked if he would rehire the fired FDA scientists, such as those who were working on the bird flu response. Alsobrooks argued firing FDA staffers for the sake of saving taxpayer dollars made no sense, since entire offices in some cases are paid with money derived from user fees.

Makary was non-committal, saying, “if an employee has not logged on to their VPN in two years, then I don’t want to rehire that individual. But if there are people that deserve a look, of course I’m happy to look at that.”

The layoffs have been carried out by the Department of Government Efficiency. Trump on Thursday reportedly told his cabinet staff that they are fully in charge of their respective departments and do not have to cede control to Musk and DOGE.

Sen. John Hickenlooper (D-Colo.) said the understaffing at FDA was causing “chaos” and a “serious morale issue.” He questioned how Makary would ensure the FDA would retain its status as upholding the gold standard of science around the world if it didn’t have enough inspectors on staff.

After first repeating that he wasn’t involved in such decisions, Makary said he would conduct an “ongoing assessment to ensure that the scientists and food director have all the resources they need to do their job.”

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