RFK Jr. Discussed Curbing FDA Head’s Role After Complaints About Management Style
Kennedy considered installing a new leader to manage the agency day to day
- Trump administration officials discussed concerns about FDA Commissioner Marty Makary’s management, according to people familiar with the matter.
- Among the topics discussed was infighting between Makary’s deputies, the people familiar with the matter said.
- Despite discussions on limiting Makary’s role, the idea was dropped, with Makary given time to improve his leadership of the agency.
WASHINGTON—Trump administration officials including Health Secretary Robert F. Kennedy Jr. have discussed scaling back the role of Marty Makary, the Food and Drug Administration commissioner, according to people familiar with the matter.
Discussions regarding concerns over Makary’s management included officials at the Department of Health and Human Services, of which the FDA is a part, and later reached the White House, the people said. Among the topics was infighting between Makary’s handpicked deputies, those people said. Kennedy weighed whether to add a leader to run the agency day to day while leaving Makary in place as a figurehead, some of the people said.
Makary pushed back on the idea, people familiar with the matter said. The officials decided to drop the idea for now, giving Makary time to improve his leadership of the agency, those people said. Kennedy remains personally loyal to Makary and wants him to succeed, the people said, though they said the secretary had concerns about how the agency is being run.
Makary, for his part, has been frustrated with what he sees as HHS’s disorganization, people familiar with the matter said.
A spokesman for the FDA referred questions to HHS, and Makary didn’t respond to requests for comment.
“The Secretary has full trust and confidence in Dr. Makary to lead the FDA,” HHS spokesman Andrew Nixon said.
White House spokesman Kush Desai said the White House maintains “total confidence in the entire HHS and FDA team,” adding, “The FDA under Commissioner Makary’s leadership has smashed a broken status quo and overseen one historic MAHA initiative after another.”
Makary, a former Johns Hopkins University surgeon who wrote bestselling books on healthcare costs and modern medicine’s failures, was confirmed in March. He has become one of the Make America Healthy Again movement’s foremost advocates on cable-news programs and at White House press conferences, while also working to reassure drug companies wary of Kennedy’s “Big Pharma” rhetoric and worried about a slowdown in agency approvals. An October analysis by RBC Capital Markets found that drug approvals slowed and rejections increased in recent months.
Two deputies chosen by Makary—the biologics center director, Vinay Prasad, and the drugs director, George Tidmarsh—clashed within the agency until Tidmarsh resigned after an alleged extortion scheme came to light, according to people familiar with the situation. Prasad was pushed out this summer but rehired about two weeks later.
Those staffing challenges caught the attention of some officials at the White House and HHS. Kennedy had a series of meetings in the days following Tidmarsh’s departure this month to discuss concerns about Makary’s management, according to people familiar with the matter.
Health officials told Kennedy that top FDA staff often had difficulty reaching Makary, who avoided email and meetings with some FDA division directors, according to people familiar with the matter.
But Kennedy and Makary patched things up, and the idea to limit his role was dropped, according to people familiar with the meeting.
Prasad has alarmed some drug-company executives worried about his approach in weighing drug benefits and risks. Roughly half a dozen top leaders in his division have left or been pushed out in recent months, people familiar with the matter said.
Prasad and Tidmarsh didn’t respond to requests for comment.
Makary this past week filled Tidmarsh’s role with the longtime leader of the FDA’s cancer-drugs unit, Richard Pazdur. Prasad, before his hiring at the FDA, criticized Pazdur on social media, blaming him for pharma “getting richer” and “the bar getting lower.” Makary on Thursday posted a picture on X of the three of them having coffee together and spoke on his podcast about his excitement to have Pazdur in the role. Makary and Kennedy lobbied Pazdur to take the job, which he initially turned down, and Makary assured Pazdur that Prasad wouldn’t interfere with his work, according to people familiar with the matter.
The discussion over Makary’s position comes as former and current FDA officials say uncertainty has plagued the agency following job cuts, a government shutdown and turnover in the leadership ranks.
Peter Lurie, a former FDA official who is now president of the Center for Science in the Public Interest, said morale inside the agency was very low. “Some of that certainly derives from the remote leadership style in which the concerns of the rank and file seem to be routinely overturned,” Lurie said.
Makary has also clashed with Republican senators over the agency’s approval of a generic form of an abortion pill, after promising antiabortion lawmakers a review of the drug’s safety. Lawmakers have privately discussed with senior leaders at the White House concerns about Makary’s handling of the situation, according to people familiar with the situation.
The review has largely stalled, people familiar with the matter said.