Makary to leave as FDA commissioner after tumultuous year, White House source says

The White House has greenlit a plan for FDA Commissioner Marty Makary to leave the Trump administration, according to a White House official granted anonymity to discuss the decision to part with the embattled agency chief.

After a little more than a year on the job that was often consumed by controversy, Makary will be departing an FDA shaken by high-level departures, bruised staff morale and a series of political fights that left him increasingly isolated.

In recent months, Makary alienated key constituencies within and outside the administration as he spent significant capital on a push to bring back former top vaccine regulator Vinay Prasad, resisted flavored vape authorizations sought by some Trump allies and frustrated anti-abortion Republicans who wanted him to move more aggressively to restrict access to the abortion pill mifepristone. Makary has also alienated some rare-disease drugmakers who have complained that the agency was inconsistent in its reviews of their medicines.

It is not clear when Makary will depart or who will replace him. He was still FDA commissioner as of early Friday afternoon.

The Wall Street Journal first reported the plan by the Trump administration to remove him as FDA leader. Administration officials often caution that plans can always change if Trump changes his mind.

Still, some of the Johns Hopkins surgeon’s priorities could live on. Makary’s National Priority Review Voucher program — which itself drew outside criticism for the involvement of political leadership — has given numerous medications the promise of priority review and could remain a tool for an administration eager to appear an ally of rare disease patients.

Another push by Makary to bring the Trump administration’s “America First” agenda into FDA user fee negotiations — proposing lowering fees for drug companies that manufacture or conduct clinical trials in the U.S. — will also take center stage as Congress debates whether to reauthorize the longstanding programs, which fund roughly half the agency.

During a recent shake-up of HHS leadership, HHS Secretary Robert F. Kennedy Jr. elevated two Makary staffers to senior counselor roles at FDA: Kyle Diamantas, deputy commissioner for human foods, and Grace Graham, the agency’s deputy commissioner for policy, legislation and international affairs.

And Sara Brenner, who worked as FDA principal deputy commissioner, recently was moved to a role at HHS. There remains a gaping hole of permanent leadership elsewhere at the agency, with its drug, biologics and tobacco centers under acting leadership amid high-profile departures that have shaken the agency.

In recent weeks, Makary made efforts to win over career staff at the FDA, repeatedly acknowledging the impact Department of Government Efficiency cuts had on morale at the agency. But many staff appear happy to turn the page on Makary’s time atop the agency.

“He will not be missed by a single career person,” said an FDA staffer granted anonymity to discuss Makary’s tenure prior to the news of his pending departure. “And we will only regret it when they manage to find someone worse.”

Still, even after multiple news reports surfaced in early May suggesting Makary could be ousted, some White House officials continued to insist the embattled FDA chief retained Trump’s confidence in recent days.

“I talked to POTUS yesterday about it. He’s fine with him,” said a senior White House official granted anonymity to discuss Makary’s standing on May 6. “He said, ‘Nah, I saw he’s getting dinged up in the press, but Marty’s great.’”

Megan Messerly contributed to this report.