The Wall Street Journal earlier on Friday first reported that President Donald Trump planned to fire Makary.
Two of the sources, who are advisers to the White House, said a decision was not final. A third source close to the White House said they were told the FDA commissioner “is done” and that Trump signed off.
The White House did not defend Makary as reports emerged of his imminent ouster, but at least publicly, Trump has not said he would replace him.
“No, no,” Trump said on Friday evening when a reporter asked whether he would bring in someone new to lead the FDA.
Top officials have been discussing possible replacements for Makary in recent days, according to the three people. But they cautioned the decision always rested with Trump and that the president could change his mind at the last minute, as he has during past staffing crises.
It remains unclear whether Trump will still move forward with firing Makary or whether he has fully reversed course.
White House spokesman Kush Desai earlier said: “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 US Department of Health and Human Services, which oversees the FDA, was not available for comment.
His firing would follow a series of controversies that drew criticism from Trump allies, supporters of Health Secretary Robert F. Kennedy Jr., conservative media, pharmaceutical companies and anti-abortion groups.
The conservative Wall Street Journal editorial board published more than half a dozen pieces criticizing Makary’s stewardship of the agency. One opinion piece asked whether any administration official had created more headaches for Trump than Makary, pointing to the FDA’s twice-repeated rejection of Replimune’s melanoma therapy.
Makary in an interview on CNBC this week said scientists reviewing the drugs had made the decision, not him.
Shares of Replimune losed nearly 22% higher on Friday, after news of Makary’s likely ouster. BMO analyst Evan Seigerman said firing Makary would be a positive for BioPharma, with expectations that any replacement would focus on stability and predictability for the industry.
Makary has also found himself in the middle of the abortion pill battle, facing growing pressure to produce a safety review he promised last year. Susan B. Anthony Pro-Life America President Marjorie Dannenfelser renewed her call this week to terminate Makary, saying his indifference was unacceptable to millions of anti-abortion voters.
Anti-abortion activists met with White House officials on Friday amid their growing frustration.
Trump was also angered by Makary’s handling of flavored e-cigarettes, a product he had pledged to protect during his 2024 campaign, with the Wall Street Journal reporting that Trump rebuked his FDA chief over the weekend for not approving them more quickly.
The White House is considering naming FDA Deputy Commissioner Kyle Diamantas, who heads the agency’s food group, as acting commissioner, according to one of the sources and an additional source.
Potential names under consideration as the actual nominee to run the agency include former FDA Commissioner Stephen Hahn and former Acting Commissioner and Assistant Health Secretary Brett Giroir, according to those two sources and a third source.
Makary’s departure would add to a series of leading officials who have left agencies within the Department of Health and Human Services, including top leaders at the Centers for Disease Control and Prevention, the National Institutes of Health and others.
A surgical oncologist at the Johns Hopkins University School of Medicine, Makary was confirmed as FDA commissioner last March. He wrote best-selling books on healthcare costs and what he described as modern medicine’s failures, and has been one of the key advocates of the Make America Healthy Again movement backed by Kennedy.