The U.S. Senate confirmed Dr. Marty Makary as the new Commissioner of the Food and Drug Administration (FDA) on Tuesday with a 56-44 vote, installing President Donald Trump's nominee to lead the agency after clearing a final procedural hurdle earlier in the day.
Makary, a professor at Johns Hopkins School of Medicine and former Fox News medical contributor, will take the helm of the FDA amid significant personnel changes and policy shifts at the agency. His confirmation comes as the Trump administration and newly confirmed Health and Human Services Secretary Robert F. Kennedy Jr. have signaled intentions to reform federal health agencies.
Confirmation Process and Key Issues
During his appearance before the Senate Committee on Health, Education, Labor and Pensions (HELP) earlier this month, Makary faced questioning on a range of critical public health issues including vaccines, chronic illness, food safety, and abortion.
A central point of contention during the confirmation process was the last-minute postponement of an FDA Vaccine Advisory Committee meeting. When pressed by Senator Patty Murray (D-Wash.) about rescheduling the meeting, Makary indicated he would "reevaluate which topics deserve a convening of the advisory committee members on [Vaccines and Related Biological Products Advisory Committee] and which may not require a convening."
While not committing specifically to rescheduling the canceled flu vaccination meeting, Makary assured senators that the committee would continue to operate under his leadership. "The VRBPAC committee will be meeting if confirmed and I'm commissioner, yes," Makary stated during his hearing.
Vision for FDA Reform
Makary has previously been critical of the agency he will now lead. In a 2021 opinion piece, he called for "fresh leadership at the FDA to change the culture at the agency and promote scientific advancement, not hinder it."
During his confirmation hearing, Makary emphasized his commitment to addressing food-related health issues, aligning with priorities highlighted by both President Trump and Secretary Kennedy.
"We now have a generational opportunity in American healthcare," he stated. "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."
Industry Impact and Regulatory Approach
Analysts at Jefferies have suggested that Makary's confirmation could be positive for the life sciences industry, particularly in the rare disease space. During his hearing, the new commissioner expressed support for expedited reviews of generics, biosimilars, and rare disease therapies.
"Dr. Makary clearly voices his support of streamlining rare disease drug development," Jefferies analysts noted, adding that he "hopes to customize the regulatory process to the condition."
Makary also pledged to address potential conflicts of interest at the FDA's advisory committees, stating he would work to eliminate situations where "people see things that appear to be a cozy relationship between industry and the regulators that are supposed to be regulating the products."
Agency Staffing Concerns
The confirmation comes amid significant staffing changes at the FDA, with reports indicating approximately one thousand employees had been laid off prior to Makary's hearing, though the agency reportedly plans to ask about 300 to return.
When questioned about these personnel decisions, Makary distanced himself from the recent firings, stating he hadn't been involved in those decisions. He committed to conducting "an assessment of the staffing and personnel at the agency" if confirmed.
Looking Forward
As Makary assumes leadership of the FDA, he faces the challenge of balancing the Trump administration's regulatory reform agenda with the agency's core mission of ensuring drug and food safety. His background as a physician-researcher and his stated commitment to scientific principles will be tested as he navigates politically sensitive issues around vaccine policy, drug approvals, and food regulation.
The confirmation represents a significant step in the Trump administration's efforts to reshape federal health agencies, with potential implications for pharmaceutical development timelines, approval standards, and public health guidance in the coming years.
