FDA nominee Makary faces scrutiny over vaccine, drug controversies

© Senate HELP Committee

Marty Makary, MD, MPH, President Donald J. Trump’s nominee to lead the U.S. Food and Drug Administration (FDA), withstood intense questioning Thursday morning during his nomination hearing before the Senate Health, Education, Labor and Pensions (HELP) Committee. The hearing covered a range of pressing topics, including the agency’s decision to cancel a key vaccine advisory meeting, drug pricing, and concerns over the future of abortion medication access.

Vaccine advisory committee cancellation

Lawmakers grilled Makary on the FDA’s recent, unexplained cancellation of its annual Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting — previously scheduled for March 13 — which determines which influenza strains should be included in the next season’s vaccines.

“The American public deserves confidence that independent scientists are reviewing the data,” Makary said. Thoroughly reviewing and considering all of the data was a reoccurring theme in his responses.

Makary pledged to reexamine the decision to cancel the meeting if confirmed. However, he noted that past advisory meetings largely aligned with international vaccine recommendations.

Mifepristone and abortion policy

Makary, a Johns Hopkins University surgeon and public policy researcher, positioned himself as an advocate for efficiency and transparency in the FDA, but stopped short of committing to maintaining access to mifepristone — the widely used abortion medication.

“I have no preconceived plans on mifepristone policy except to take a solid, hard look at the data and to meet with the professional career scientists who have reviewed the data at the FDA, and to build an expert coalition to review the ongoing data,” Makary said in response to whether he would reinstate in-person dispensing requirements for the drug. He assured lawmakers that he would adhere to the FDA’s independent scientific review process but avoided directly endorsing the agency’s long-standing approval of the drug.

Drug pricing

Makary also faced questions about rising prescription drug costs and competition within the pharmaceutical industry. He signaled support for fast-tracking approvals of generic and biosimilar drugs to foster competition and lower prices.

Sen. Susan Collins (R-Maine) asked whether he would support a new expedited approval pathway for biosimilars, particularly for insulin. Makary responded that he was in favor of such efforts, without cutting corners on scientific reviews. “It is one of several strategies that the FDA can do to try to alleviate the problems of high drug prices, inadequate competition or underperformance of competition and the drug shortage in the United States,” Makary said.

He added that other strategies could include “changing the way we look at generic drugs,” moving medications to over-the-counter.
“Does Naloxone really need to be a prescription-only medication? Does an EpiPen need to be prescription only?” Makary posed the question. “If they can be over the counter, and we can feel confident about public safety with those products on the shelf at a pharmacy, it would force the companies to put a price on the shelf. I do believe that price transparency will have an effect on the entire marketplace.”

FDA staffing concerns

The FDA was not exempt from the federal workforce cuts enforced by the Trump administration and the Department of Government Efficiency (DOGE), with ABC News reporting late last month that roughly 700 members of the agency were let go — more than 220 of them from the agency’s medical device center — which would represent roughly 10% of the program’s total staffing. Although, the agency did announce last week that they would be reinstating some of the fired staffers.

In response to senators’ concerns, Makary distanced himself from the FDA layoffs.

“I was not involved in any of those personnel decisions,” he said, committing to conducting an internal review of the agency’s staffing needs if confirmed.

Makary’s nomination comes at a pivotal time as the FDA faces mounting challenges in drug approval processes, vaccine oversight and restoring public trust under the new leadership of Health and Human Services Secretary Robert F. Kennedy Jr.

The Senate HELP Committee is expected to vote on Makary’s nomination next Thursday, March 13.