President Trump is weighing the removal of FDA Commissioner Dr. Marty Makary, frustrated with what aides describe as halting decision-making at the agency, though no final determination has been made, according to a person familiar with the deliberations.
Makary's eight-month tenure has been turbulent. The agency has rejected applications for rare-disease treatments, abruptly reversed course on some approvals, and faced mounting pressure on hot-button political issues including abortion pills and flavored vaping products. Multiple high-ranking officials have departed or been temporarily reassigned during his watch.
The frustration centers on several specific decisions. Trump has expressed displeasure with the pace of flavored vape approvals, a priority from his 2024 campaign promise to protect the vaping industry. Only this week did the FDA authorize its first fruit-flavored e-cigarettes, a move that drew criticism from health advocates worried about youth nicotine use.
Makary has also faced pressure from Republican senators over a promised safety review of the abortion pill mifepristone. Though he committed during his March 2025 confirmation to pursue such a review, none has materialized more than a year later. Bloomberg reported in December that Makary instructed staff to hold off releasing the review until after the midterm elections, citing electoral sensitivities.
The commissioner's tenure has been marked by jarring rejections of promising therapies. In a particularly contentious decision, the FDA declined to even review UniQure's gene therapy application for Huntington's disease, sparking outrage on Capitol Hill. That move led to the second removal of Dr. Vinay Prasad, who oversees the office that handles such applications. Prasad had been briefly forced out the prior year over a separate gene therapy decision before being reinstated.
The agency also initially rejected Moderna's mRNA flu vaccine application before reversing itself within days, signaling inconsistency in decision-making processes.
Makary came to the job as an ideological ally of Health Secretary Robert F. Kennedy Jr. Both men had questioned the Biden administration's COVID response and embraced the "Make America Healthy Again" movement. In his early months, Makary championed FDA initiatives to remove artificial dyes from food and tighten standards for COVID vaccine approvals, moves aligned with Kennedy's health philosophy.
White House press secretary Kush Desai declined to address the potential firing directly, saying only that "President Trump has assembled the most experienced and talented administration in history, an administration that continues to focus on delivering more historic victories for the American people."
The source cautioned that Trump could yet change course, and no replacement has been discussed publicly. Makary's departure would mark another significant shake-up at an agency already destabilized by rapid leadership changes and conflicting directives.
Author Sarah Mitchell: "Makary's brief run reveals the tension between Trump's campaign promises on vaping and abortion, and the FDA's traditional role as a scientific arbiter; incompetence or political calculation, the outcome has been chaos."
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