After the contentious Senate confirmation of Robert F. Kennedy Jr., another crucial governmental health leadership nominee—the proposed head of the FDA—took center stage Thursday.
At his confirmation hearing before the Senate’s Health, Education Labor and Pensions Committee, British-American surgeon Martin Makary, M.D., fielded questions from lawmakers on a wide range of topics, including his plans to mitigate the chaotic staffing changes hitting the FDA.
If confirmed, Makary would take the agency's reins amid a storm of changes unleashed by the Elon Musk-led Department of Government Efficiency (DOGE). After mass firings stemming from “workforce optimization” procedures permitted by an executive order from President Donald Trump, the DOGE more recently terminated leases for at least 748 federal sites, including dozens of FDA facilities.
Amid concerns that FDA firings may slow down the agency's drug review process, Makary told lawmakers he wants to ensure that the review process is conducted “properly” and “expeditiously.” However, he said he's “open to ideas” on boosting government efficiency and repeatedly pledged to assess the agency’s staffing levels.
Outside of the changes to the FDA’s workforce, senators grilled Makary on his plans for expert panels, such as a key FDA advisory committee on vaccines. The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) was set to meet next week to discuss updated strain recommendations for flu vaccines, but the event was abruptly canceled. In a Feb. 28 letter (PDF) to Makary, some Senate Democrats blasted the decision.
While Makary repeatedly reminded senators that he was not involved in the decision to call the meeting off, he took the stance that U.S. expert recommendations often “rubber-stamp” the strain recommendation decisions of the World Health Organization’s Global Influenza Program.
Makary, who in 2022 called a lack of VRBPAC vote on a COVID-19 booster “unconscionable,” did not commit to reconvening the canceled meeting. Instead, he pledged to “reevaluate which topics deserve a convening of the advisory committee members," later promising that the VRBPAC “will be meeting," going forward, if he is confirmed as commissioner.
As for the members of the FDA’s independent advisory committees, Makary told lawmakers that “we need to review the ethics policy,” citing possible conflict-of-interest concerns.
“I want life sciences companies to thrive, but we need to call balls and strikes and to keep that independent scientific review process free of any conflicts,” the FDA commissioner nominee said, echoing a frequent talking point of RFK Jr.
However, the FDA commissioner nominee said he has “no preconceived plans” to rearrange or remove experts on the committees.
Other than his road map for navigating more recent changes at the FDA, lawmakers raised other concerns surrounding topics such as clinical trial diversity and drug shortages.
In addition, Makary outlined a wider goal to “use common sense” to answer some questions “we’ve never asked before at the FDA,” such as the long timeline for drug approvals and whether some prescription products can be shifted to over-the-counter offerings. If confirmed, the nominee said he would push for quicker generic and biosimilar approvals, he noted.
If confirmed, Makary would lead the FDA under RFK Jr. and work with other health officials such as Mehmet Oz, M.D., also known as Dr. Oz, who was picked to run the Centers for Medicare & Medicaid Services.