White House officials have signed off on a plan to replace Food and Drug Administration Commissioner Marty Makary after months of turmoil at the agency and criticism of some of his decisions, according to two individuals who spoke on the condition of anonymity to describe internal operations.
The FDA has seen a wave of senior-staff departures and faced scrutiny from pharmaceutical industry groups, antiabortion advocates and, at times, former FDA commissioners since Makary was installed as the agency’s leader last year. White House and senior health officials have spent months discussing whether to reduce Makary’s responsibilities or replace him altogether.
The individuals said the decision rests with President Donald Trump. Asked Friday evening about reports of Makary’s ouster, Trump disclaimed responsibility.
“I’ve been reading about it, but I know nothing about it,” the president told reporters.
Makary’s departure would be accompanied by broader changes to the FDA, after senior administration officials assessed the agency in recent months and identified opportunities for more efficient operations, the individuals said. They did not specify the scope of those expected changes. And they cautioned that the White House’s timing and plans could shift, noting that Trump has previously reversed staffing decisions before they were publicly announced.
Administration officials have not settled on an acting leader for the FDA, the people said.
The Department of Health and Human Services and Makary did not respond to requests for comment Friday.
The White House on Friday afternoon did not respond to questions about Makary or broader changes to the FDA. A spokesman instead touted the president’s record.
“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,” spokesman Kush Desai said in a statement.
The Wall Street Journal first reported the White House’s plan to replace Makary.
The ouster of Makary would be the latest shake-up at the Department of Health and Human Services, with the president increasingly switching out deputies selected by Health Secretary Robert F. Kennedy Jr. and replacing them with more conventional choices.
Trump last month named former deputy U.S. surgeon general Erica Schwartz to helm the Centers for Disease Control and Prevention, his third pick to run the agency charged with offering public health guidance to Americans. The White House last year pulled the nomination of Dave Weldon, a former congressman known for his anti-vaccine views and Kennedy’s first choice to lead the CDC, and pushed out Susan Monarez, the administration’s second choice, after she clashed with Kennedy.
Trump last week also announced Nicole Saphier, a longtime Fox News contributor and radiologist, as his third choice to serve as U.S. surgeon general, and pulled the nomination of Casey Means, a health products entrepreneur and popular online personality. Means, who left the medical establishment in her final year of residency, had been championed by some of Kennedy’s Make America Healthy Again supporters. The White House last year withdrew the nomination of Janette Nesheiwat, the president’s first pick to serve as surgeon general.
The White House in February also elevated Chris Klomp, a longtime health care entrepreneur, to serve as Kennedy’s top deputy, part of a broader attempt to stabilize the health agencies ahead of this fall’s midterm elections.
There are several senior vacancies at the FDA, including an acting chief of both the vaccine and drug centers. Sara Brenner, who served as acting FDA commissioner once Trump took office and then became the No. 2 agency official, was already moving roles to become an HHS senior counselor for public health. She was slated to have a “congratulations and well wishes” party at the agency Friday, according to an invite obtained by The Washington Post.
Makary, a Johns Hopkins University School of Medicine surgeon and former Fox News contributor, came to the White House’s attention in the first Trump administration and supported its work on price transparency. He rose to further prominence by criticizing the medical establishment amid the coronavirus pandemic.
“FDA has lost the trust of Americans, and has lost sight of its primary goal as a regulator,” Trump said in announcing Makary for the role in November 2024. “The Agency needs Dr. Marty Makary, a Highly Respected Johns Hopkins Surgical Oncologist and Health Policy Expert, to course-correct and refocus the Agency.”
The Senate confirmed Makary in March 2025 to lead the FDA, with three Democrats joining Republicans in the 56-44 vote, a rare instance of bipartisan support for a top Trump health pick.
Makary has elevated some initiatives key to Kennedy’s Make America Healthy Again movement, such as pushing companies to rid the food supply of artificial dyes and working on a plan to tighten a decades-old loophole allowing food companies to put chemicals in their products without notifying the nation’s food regulators. He has recently touted his record, and his supporters say he is a leader who challenges the status quo.
But Makary drew the ire of industry and the medical community after the agency sidelined approvals for drugs for skin cancer and Huntington’s disease. Makary called criticism over the rejections “corporate spin” in an interview Tuesday with CNBC.
“If your drug works, it’s going to get approved,” Makary said. “Do you throw science out the window do whatever the media tells you to do, or whatever the lobbyists and corporate interests tell you to do, or do you do what’s right?”
During Makary’s tenure, the FDA laid out a stricter approach for vaccine approvals that public health experts have pushed back against. Vinay Prasad, a top FDA official and key Makary ally, laid out the change in an internal email that was leaked. Prasad, whose nearly year-long tenure as the top vaccine regulator was controversial, has since left the agency.
Last year, Makary launched a program aimed at expediting certain drug review decisions, which has been part of Trump’s push for lower drug prices and efforts to boost domestic manufacturing programs.
Richard Pazdur, a longtime FDA official, questioned the legality and pace of Makary’s plans to significantly shorten review times for some drugs. He decided to retire last year three weeks after taking on the role as the nation’s top drug regulator.
A pharmaceutical executive, who spoke on the condition of anonymity to speak candidly about sensitive matters, said the industry has opposed some of Makary’s moves but supported others.
“He’s the devil we’ve gotten to know,” the executive said, adding that a change at the top FDA slot now would be disruptive.
Meanwhile, Makary has faced heat from antiabortion leaders and some Republican senators who have sought more restrictions on the abortion pill mifepristone.
As commissioner, Makary helped block an effort by a federal vaccine panel to potentially stop recommending covid-19 mRNA shots. Officials with the FDA, which is charged with approving vaccines, could have interpreted the panel’s proposal as a push to remove the vaccines from the market. Makary opposed the plan, which did not move forward, according to two people familiar with the matter who spoke on the condition of anonymity to describe internal discussions.
Ahead of the midterm elections, Trump administration officials have been downplaying their overhaul of vaccine policy, including a sweeping and controversial reduction of the childhood vaccine schedule, and instead touting their work on food and drug pricing. It comes as Republican pollsters have warned vaccine skepticism is “politically risky.”
Christopher Rowland contributed to this report.
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