The administration, as well as HHS, publicly praised Marty Makary’s leadership despite persistent upheaval at the agency.
The White House is rallying behind Food and Drug Administration Commissioner Marty Makary after the abrupt ousting of one of his top deputies over the weekend, the latest tumult in an agency that’s seen plenty this year.
A new top drug regulator will likely be installed on Wednesday to replace George Tidmarsh as director of the FDA’s Center for Drug Evaluation and Research, according to a Health and Human Services official granted anonymity to discuss personnel planning.
That individual will not be Vinay Prasad, the controversial head of the FDA’s biologics center, in charge of vaccines, who also works as the agency’s chief medical and scientific officer, they added.
“President Trump pledged to lower costs and Make America Healthy Again by cutting red tape and embracing innovation,” White House spokesperson Kush Desai wrote in an email. “The FDA under Marty Makary’s leadership has consistently delivered on this pledge, and the White House maintains total confidence in the FDA and the entire HHS team to continue delivering more victories for the American people.”
Makary also has the backing of his boss, HHS Secretary Robert F. Kennedy Jr.
“The secretary has full trust and confidence in Dr. Makary to lead the FDA,” HHS spokesperson Andrew Nixon said.
Tidmarsh’s resignation on Sunday followed weeks of mounting tension over his Sept. 29 LinkedIn post questioning the efficacy of an FDA-approved drug made by biopharmaceutical company Aurinia Pharmaceuticals. That culminated in the regulator being placed on administrative leave on Friday “after the Office of the General Counsel and the Office of the Inspector General were notified of serious concerns about his personal conduct,” HHS spokesperson Emily Hilliard said.
On Aurinia’s earnings call on Tuesday morning, CEO Peter Greenleaf noted his company filed a complaint on Sunday against Tidmarsh in the U.S. District Court for the District of Maryland.
“If you have questions regarding the complaint, we refer you to the complaint itself as we will not be commenting further on this matter,” Greenleaf said.
The lawsuit claims Tidmarsh used his FDA position to follow through on a yearslong intimidation campaign against Kevin Tang, a biotech investor who once worked with him, and companies Tang backed. The complaint details messages from Tidmarsh to Tang and other associates and contains copies of emails Aurinia says show that the former CDER chief tried to solicit a bribe through his lawyer in exchange for regulatory aid.
The Tidmarsh departure is the latest development to rock the FDA.
Earlier this year, Prasad was temporarily ousted by the White House after right-wing provocateur Laura Loomer led a crusade to remove the hematologist-oncologist and health researcher. That followed his push to get Sarepta Therapeutics to stop selling its Duchenne muscular dystrophy drug Elevidys due to safety concerns.
The FDA ultimately loosened restrictions on the drug. But Makary convinced White House Chief of Staff Susie Wiles to allow Prasad to return to his job shortly after.
An administration official granted anonymity to discuss Prasad’s role at the FDA acknowledged there have been “some issues with his management style and his communication style.”
“I wouldn’t say he’s in hot water, but I wouldn’t say he’s not in hot water, either,” the administration official said.
But the official said that Prasad is from a substance point of view “in line with what the president wants.” They described Prasad as “an innovative mind who can deliver” and noted that frustrations with his personal leadership style are not “representative of systemic issues at the FDA or its leadership.”
Morale among rank-and-file FDA staff has nosedived in the months following steep Department of Government Efficiency-driven staff cuts at the agency earlier this year, according to two current FDA employees granted anonymity to discuss the impact of Tidmarsh’s departure.
Employees at CDER thought Tidmarsh was a professional and someone that they could work with, one of the current employees said.
“He worked hard to ensure that our staff are retained and to make sure our processes are continuing,” said one employee, granted anonymity for fear of retribution. “We were working with him, he was a good partner.”
But Tidmarsh’s LinkedIn post was not a “recoverable situation under any circumstance,” according to a former FDA official granted anonymity to discuss the development.
“It makes you wonder about judgment on other things,” the former official said.
Tidmarsh did not respond to requests for an interview.
Daniel Fabricant, a previous FDA official and CEO of the Natural Products Association, a dietary supplement group, said that any time a regulator speaks in public, the appearance of a conflict of interest is a problem.
“Anytime you’re the regulator and you’re speaking on the industry you regulate, you have to know that that’s going to be regarded as on the record,” Fabricant said. “And even if you say till you’re blue in the face it is in my personal capacity, that’s always going to be what it’s attached to, it’s really tough to get out of that.”
Makary has supported President Donald Trump’s efforts to reduce the price of prescription drugs, but has drawn fire from some conservative lawmakers over the FDA’s approval of a generic version of the abortion pill mifepristone.
A former HHS official granted anonymity to discuss the relationship between Makary and Tidmarsh said that they hit it off when they met in October 2024 at a Stanford conference organized by now-NIH Director Jay Bhattacharya. Makary, the person said, liked the idea of bringing in somebody with industry experience. When Prasad was forced out of the agency, Tidmarsh expanded his purview for a few weeks — but when Prasad returned, the two fought, the former HHS official said.
Tidmarsh is a co-author on articles published this year in the Journal of the Academy of Public Health, an online journal founded by Makary, Bhattacharya and Advisory Committee on Immunization Practices Chair Martin Kulldorff before they joined Trump’s administration. Tidmarsh and Bhattacharya also overlapped as Stanford faculty.
The FDA’s drug center is the biggest in the agency and historically has seen steady leadership across multiple presidential administrations under longtime top drug regulator Janet Woodcock, who retired from FDA in 2024 after nearly four decades at the agency.
“There is more concern about the fate of the agency than at any time in its history,” said a different former FDA official granted anonymity to discuss the upheaval. “FDA is in crisis.”