FDA Commissioner Resigns Following Period of Political Pressure

Marty Makary, the commissioner of the US Food and Drug Administration (FDA), resigned from his position on Tuesday. His departure comes after a 13-month period at the agency that saw frequent disagreements with the White House, members of Congress, and the public. President Donald Trump confirmed the news, stating that while Makary was a talented doctor, he was having some difficulty in the role. Kyle Diamantas, who previously led the agency’s food policy, has been named as the acting commissioner.

According to The Guardian Health, Makary’s time at the FDA was defined by several controversial decisions. One major point of conflict involved the approval of fruit-flavored vapes. Reports from the Wall Street Journal suggest that President Trump had signed off on a plan to fire Makary after the commissioner initially refused to approve these products. Although Makary eventually allowed the vapes to move forward, the delay caused significant tension between him and the White House.

Beyond vaping, Makary faced pressure from various sides. MedPage Today reports that pharmaceutical companies were unhappy with what they called inconsistent reviews of their products. Meanwhile, conservative members of Congress criticized Makary for his handling of mifepristone, a medication used for abortion. These lawmakers accused him of slowing down the review process for the drug. Additionally, Makary had to manage the interests of Health and Human Services Secretary Robert F. Kennedy Jr., who has been very vocal about his concerns regarding the safety of vaccines and food additives.

Makary’s leadership also saw significant changes within the agency itself. There was high turnover among top officials, including the firing and later re-hiring of Vinay Prasad, who served as the director of the FDA’s Center for Biologics Evaluation and Research. Makary introduced several new initiatives, such as changing the number of required studies for drug approval from two to one and using new statistical methods for clinical trials. However, MedPage Today notes that many of these programs have not gone through the official federal rulemaking process. This means they could be easily overturned by the next leader of the agency.

Vaccine policy remained one of the most contentious areas during Makary’s tenure. Critics, including former acting FDA commissioner Janet Woodcock, argued that the agency showed a pattern of hiding information that supported vaccine safety. For example, the FDA stopped the publication of research on vaccines for shingles and Covid. There was also a public backlash after the agency refused to consider a new flu vaccine from Moderna, a decision that was later reversed. Peter Lurie, a former associate commissioner at the FDA, stated that the administration likely realized they had gone too far regarding vaccine recommendations as the midterm elections approached.

In a text shared by President Trump on social media, Makary expressed pride in his work. He highlighted that he had announced 50 major reforms, including reducing the time it takes to review new drugs from one year to just one or two months. He also mentioned new guidance for the use of psychedelics and changes to labels for menopausal hormone replacement therapy. Despite these claims of success, the atmosphere at the FDA remained unstable throughout his time in office.

As Makary leaves, the question of what comes next for the FDA remains open. While Kyle Diamantas is currently the acting head, other names have been mentioned as potential permanent replacements. According to reports from Axios, these include former assistant secretary for health Brett Giroir and former FDA commissioner Stephen Hahn. Makary is the second major health agency head to leave the administration, following the departure of CDC Director Susan Monarez last August. For now, the agency faces a period of uncertainty as it waits to see which of Makary’s policies will stay and which will be changed by his successor.