The United States Senate voted Tuesday to confirm Dr. Martin Makary, a surgeon from Johns Hopkins University, as the next commissioner of the Food and Drug Administration. The confirmation passed with a vote of 56-44, with three Democratic senators joining 53 Republicans in support of Makary’s appointment.
The newly confirmed commissioner will oversee an extensive regulatory body that maintains oversight of food safety, pharmaceutical products, tobacco, and medical devices across the American economy. The confirmation faced opposition from some lawmakers, including Senator Bernie Sanders, who serves as the ranking minority member on the Senate Health, Education, Labor and Pensions (HELP) Committee.
HELP Committee Chairman Bill Cassidy (R-La.) expressed strong support for the confirmation, highlighting Makary’s credentials and vision as key qualifications for leading the FDA.
As Makary assumes leadership of the agency’s approximately 18,000 employees, he faces immediate challenges under the Trump
administration, including potential workforce reductions. The situation is complicated by the fact that roughly half of the FDA’s staff positions are funded through industry user fees, including those established by the Prescription Drug User Fee Act.
During his confirmation hearings, Makary addressed concerns about potential staff cuts, stating he was not involved in previous layoff decisions that affected hundreds of FDA employees. He committed to conducting any future workforce evaluations independently while ensuring remaining staff would have adequate resources to perform their duties effectively.
The appointment has drawn attention from industry leaders, with John Crowley of the Biotechnology Innovation Organization warning against implementing severe staffing reductions without proper consideration.
Makary’s tenure begins amid pressure to reshape certain FDA policies, influenced by directives from President Trump and newly appointed Health and Human Services Secretary Robert F. Kennedy Jr., who has expressed skepticism about vaccines. The agency has already generated controversy by canceling an important vaccine advisory committee meeting.
Several critical decisions await the new commissioner, including the evaluation of Moderna’s next-generation COVID-19 vaccine, which faces a May 31 deadline. Makary’s previous positions on COVID-19 vaccines have drawn attention, particularly his opposition to vaccine mandates and his advocacy for considering natural immunity from prior infections in public health policies.
Additional pending FDA decisions include reviews of Gilead’s bi-annual HIV prevention treatment, a novel cell therapy for a rare skin condition, and a gene therapy targeting a genetic metabolic disorder. The agency may also face renewed scrutiny of direct-to-consumer pharmaceutical advertising, though previous attempts by the Trump administration to restrict such practices were unsuccessful.
The confirmation comes at a time when the administration has raised questions about pharmaceutical products’ role in chronic disease patterns, a topic recently examined in a closed federal commission meeting. The FDA’s new leadership will need to navigate these complex policy considerations while maintaining the agency’s core regulatory functions.
The appointment represents a significant shift in FDA leadership, with Makary taking control of an agency that oversees products accounting for roughly 20% of U.S. consumer spending. His tenure begins amid various challenges, from potential organizational restructuring to crucial decisions on innovative medical treatments, all while maintaining the agency’s fundamental mission of protecting public health through effective regulation of food, drugs, and medical devices.