Trump Aims to Replace FDA Head Makary, Report Says

The White House Considers Firing FDA Commissioner Marty Makary

In a potential shift within the federal health department, the White House has reportedly approved a plan to fire U.S. Food and Drug Administration (FDA) Commissioner Marty Makary. This move could mark the next in a series of leadership changes at the agency, according to sources familiar with the matter. The Wall Street Journal first reported on Friday that President Donald Trump was considering removing Makary from his position.

Two sources who are advisers to the White House indicated that the decision is not yet final. However, a third source close to the administration stated that Makary "is done" and that Trump had signed off on the action. Despite this, the White House has not officially confirmed the move.

White House spokesman Kush Desai emphasized the administration's focus on delivering historic victories for the American people, stating, "President Trump has assembled the most experienced and talented administration in history."

The U.S. Department of Health and Human Services, which oversees the FDA, did not respond to requests for comment.

Makary Faces Growing Criticism

Makary’s potential firing comes amid mounting criticism from various groups, including Trump allies, supporters of Health Secretary Robert F. Kennedy Jr., conservative media, pharmaceutical companies, and anti-abortion organizations. The Wall Street Journal editorial board has published multiple pieces criticizing Makary’s leadership, highlighting the FDA's repeated rejection of Replimune's melanoma therapy as a point of contention.

In an interview on CNBC, Makary stated that the scientists reviewing the drugs made the decisions, not him. Shares of Replimune rose 16% after news of Makary’s likely removal was reported. Analysts from BMO, such as Evan Seigerman, suggested that firing Makary could be positive for the biopharma industry, as a new leader might bring stability and predictability.

Makary has also faced scrutiny over his handling of the abortion pill issue, with pressure to complete a safety review he promised last year. Susan B. Anthony Pro-Life America President Marjorie Dannenfelser called for his termination, citing his perceived indifference to pro-life voters.

Anti-abortion activists met with White House officials, expressing frustration over the situation. Additionally, Trump was reportedly upset by Makary's handling of flavored e-cigarettes, a product he had pledged to protect during his 2024 campaign.

Potential Replacement for Makary

The White House is considering several candidates to replace Makary. According to sources, FDA Deputy Commissioner Kyle Diamantas, who leads the agency's food group, could serve as acting commissioner. Other potential nominees include former FDA commissioner Stephen Hahn and former acting commissioner and Assistant Health Secretary Brett Giroir.

Departures and Leadership Challenges

The FDA under Kennedy and Makary has experienced significant turnover, with high-profile departures, internal conflicts, and accusations of politicization. The agency has lost thousands of employees due to layoffs and resignations, and it has cycled through five directors of its drug center since January last year.

Senior regulators such as Peter Marks, Rachael Anatol, Richard Pazdur, and Jacqueline Corrigan-Curay have left the agency. Vinay Prasad, who was briefly ousted as biologics division director before being reinstated, recently faced controversy over rare-disease treatment decisions before leaving again.

Jesse Goodman, a former FDA Chief Scientist, noted that a new commissioner would need to rebuild the top leadership, as both of the FDA's drug-regulating divisions are currently led by acting directors. He pointed out that the current situation has created gaps in expertise and experience.

Makary's departure would add to a trend of leading officials leaving agencies within the Department of Health and Human Services, including the Centers for Disease Control and Prevention and the National Institutes of Health.

A surgical oncologist at the Johns Hopkins University School of Medicine, Makary was confirmed as FDA commissioner in March. He authored best-selling books on healthcare costs and modern medicine's failures, and he has been a key advocate for the Make America Healthy Again movement backed by Kennedy.