Earlier on Friday, The Wall Street Journal first reported that President Donald Trump intended to terminate Makary.
Two sources, who are advisers to the White House, indicated that a decision has not yet been finalized. A third source close to the White House claimed that they were informed the FDA commissioner “is done” and that Trump had given his approval.
As reports surfaced regarding his likely dismissal, the White House did not defend Makary; however, Trump has not publicly committed to replacing him.
“No, no,” Trump replied on Friday evening when asked by a reporter if he would appoint someone new to lead the FDA.
In recent days, top officials have been deliberating potential successors for Makary, according to the three sources. However, they emphasized that the final decision rests with Trump and that he could change his mind at any time, as he has in previous staffing dilemmas.
It remains uncertain whether Trump will proceed with firing Makary or if he has completely reversed his position.
White House spokesman Kush Desai previously stated: “President Trump has assembled the most experienced and talented administration in history, one that continues to focus on achieving more historic victories for the American people.”
The U.S. Department of Health and Human Services, which oversees the FDA, did not respond to requests for comment.
MAKARY FACES MOUNTING CRITICISM
His potential dismissal would follow numerous controversies that have attracted backlash from Trump allies, supporters of Health Secretary Robert F. Kennedy Jr., conservative media, pharmaceutical companies, and anti-abortion organizations.
The conservative Wall Street Journal editorial board published several articles criticizing Makary’s management of the agency. One opinion piece questioned if any administration official had caused Trump more headaches than Makary, highlighting the FDA’s repeated rejections of Replimune’s melanoma therapy.
In a CNBC interview this week, Makary stated that the decision regarding the drugs was made by scientists, not himself.
Following news of Makary’s likely exit, shares of Replimune closed nearly 22% higher on Friday. Analyst Evan Seigerman from BMO indicated that firing Makary would be beneficial for BioPharma, with expectations that any successor would emphasize stability and predictability for the industry.
Makary has also found himself at the center of the abortion pill debate, facing increasing pressure to deliver a safety review he promised last year. This week, Susan B. Anthony Pro-Life America President Marjorie Dannenfelser reiterated her call for Makary’s termination, stating his perceived indifference was unacceptable to millions of anti-abortion voters.
Anti-abortion activists met with White House officials on Friday due to their escalating frustration.
Trump was reportedly unhappy with Makary’s management of flavored e-cigarettes, a product he pledged to safeguard during his 2024 campaign. The Wall Street Journal reported that Trump rebuked his FDA chief over the weekend for not approving them more swiftly.
FINDING A REPLACEMENT
The White House is reportedly considering appointing FDA Deputy Commissioner Kyle Diamantas, who oversees the agency’s food division, as acting commissioner, according to one source and an additional source.
Potential candidates for the permanent position to lead the agency include former FDA Commissioner Stephen Hahn and former Acting Commissioner and Assistant Health Secretary Brett Giroir, according to two sources and another individual.
EXODUS OF EXPERIENCED REGULATORS
Under Kennedy and Makary, the agency has faced high-profile departures, conflicts among senior leaders, accusations of politicization, and low morale. It has lost thousands of employees due to layoffs and resignations, cycling through five directors of its drug center since January last year.
Senior regulators who have departed include Biologics officials Peter Marks and Rachael Anatol, as well as drug evaluation figures Richard Pazdur and Jacqueline Corrigan-Curay.
Vinay Prasad, ousted as biologics division director last July only to be reinstated two weeks later, was recently involved in controversial decisions related to rare disease treatments before his final departure last month.
Former FDA Chief Scientist Jesse Goodman noted that a new commissioner would need to rebuild top leadership, as both divisions regulating drugs at the FDA are currently run by acting directors.
“There is a vacuum that has created a lot of gaps in expertise and experience,” Goodman remarked.
Makary’s exit would contribute to a trend of high-ranking officials leaving agencies within the Department of Health and Human Services, which has seen significant turnover at the Centers for Disease Control and Prevention, the National Institutes of Health, and more.
A surgical oncologist at Johns Hopkins University School of Medicine, Makary was confirmed as FDA commissioner last March. He authored best-selling books on healthcare costs and criticized modern medicine’s shortcomings and has been a prominent advocate for the Make America Healthy Again movement supported by Kennedy.
