FDA Ousts Another Top Official: Who’s Behind the Shakeup — and Why?
Something very strange is happening inside the FDA.
This article originally appeared on The Defender and was republished with permission.
Guest post by Michael Nevradakis, Ph.D.
The FDA fired Tracy Beth Høeg, the agency’s top drug regulator and a staunch advocate for vaccine safety. It’s the latest in a string of high-profile exits from the agency, many of which followed the appointment of Chris Klomp as HHS’ No. 2 official, Reuters reported. TrialSite News suggested the departures were “associated” with the “COVID-era dissent class” — and that Klomp may have directed the changes on behalf of the White House. The Defender could not verify that claim.
Tracy Beth Høeg, M.D., Ph.D., an epidemiologist and sports physician who supported studying — and reducing — the recommended childhood vaccination schedule, was fired by the U.S. Food and Drug Administration (FDA). Høeg was acting director of the FDA’s Center for Drug Evaluation and Research (CDER).
In a post on X last Friday, Høeg wrote that she “learned so much” and is leaving the FDA “with no regrets.”
And in an interview with MD Reports published shortly after her firing, Høeg said she first learned about the agency’s plans to fire her earlier in the week, through media reports.
On May 15, two unnamed FDA officials offered her the choice to resign or be fired. When she refused to resign, she was fired on the spot.
“I said I didn’t want to resign,” Høeg told MD Reports. “I said I’m not signing a letter of resignation if it’s not my choice.”
During her time at the FDA, Høeg was involved in several research initiatives broadly tied to the Make America Healthy Again (MAHA) agenda. According to The New York Times, this included work on an “intense investigation” last year that linked the COVID-19 vaccines to “at least” 10 child deaths.
Høeg also authored a report recommending that the number of diseases covered by the recommended childhood vaccination schedule be reduced from 17 to 11.
In January, U.S. Health Secretary Robert F. Kennedy Jr. implemented these recommendations. However, in March, a federal court issued a stay pausing adoption of the new schedule.
According to The Associated Press, Høeg was most recently involved in the FDA’s review of a petition to add new warnings to antidepressants about risks to pregnant women, “including fetal abnormalities that could lead to autism and other disorders.”
Høeg’s ouster comes amid a broader shakeup at the FDA. Last week, Dr. Marty Makary resigned his FDA commissioner post following rumors that he would be fired. Last month, Dr. Vinay Prasad resigned from the Center for Biologics Evaluation and Research (CBER) — for the second time in less than a year.
Høeg “worked closely” with Makary and Prasad, STAT News reported. She was first hired in April 2025 as a special assistant to Makary before taking the lead at CDER in December 2025.
Michael Davis, M.D., Ph.D., CDER’s deputy director, was promoted to acting director. Høeg did not respond by press time to The Defender’s request for comment.
Høeg ‘refused to bow’ to political, lobbyist pressure
Høeg told MD Reports that the two FDA officials who told her she was fired “were both actually quite sad” — and made it clear that “it wasn’t their decision.”
They told her the decision came “from someone above them, from someone way above their pay grade,” Høeg said, adding that she suspects her firing is connected to Makary’s departure.
“I think they didn’t want to have the people there who were closest to him anymore,” Høeg said.
During her time at the FDA, there was frequent “political pressure and … pressure from lobbyists to do things in order to keep our jobs or protect our reputations,” Høeg said. But she, Makary and Prasad “refused to bow” to the pressure.
“I was really proud of what we did in CDER — that we held our ground,” Høeg said. “If we didn’t feel like [a drug] met the level of evidence for approval, we didn’t give in to those pressures.”
She said working conditions inside the FDA were not chaotic, contrary to media reports. The environment inside CDER was “incredibly fulfilling.” She “wouldn’t have resigned from it,” she said.
Jeffrey Tucker, president and founder of the Brownstone Institute, described Høeg as “a breath of fresh air at the FDA” — and “as a scientist” during the COVID-19 pandemic.
“She is responsible for a great deal of excellent research over these six hard years, from masking to vaccine effectiveness and safety. She is a voice of sanity and clarity, exactly the kind of person we need to help guide us out of this crisis of confidence,” Tucker said.
‘Ideological cleansing disguised as bureaucratic housekeeping’
U.S. Department of Health and Human Services (HHS) spokesperson Emily Hilliard told NBC News that the Trump administration is “actively searching for strong candidates for key leadership positions across HHS, including the FDA, with a focus on experienced individuals who can strengthen agency operations, continue to advance significant reforms, and maintain public trust.”
“In the meantime, the FDA and HHS continue to operate under solid leadership and respond aggressively to immediate public health situations,” Hilliard said.
HHS did not respond to The Defender’s request for comment.
TrialSite News described HHS’ statements as “polite euphemisms for violent institutional events” which mask “something far more unsettling” now underway at the FDA — “an ideological cleansing disguised as bureaucratic housekeeping.”
“This no longer looks like ordinary bureaucratic turnover inside the FDA,” Daniel O’Connor, founder and CEO of TrialSite News, told The Defender. “What TrialSite News is documenting increasingly resembles a political and ideological realignment of federal health power — where dissent tolerated during the COVID era is now becoming incompatible with operational control inside the administrative state.”
Steve Kirsch, founder of the Vaccine Safety Research Foundation, said Høeg’s firing “should decimate trust in the FDA,” as it “sends a clear message that scientific integrity is not tolerated at the FDA.”
“It also sends a message to the public that honest scientists who seek truth are expunged from the FDA for no reason. For the foreseeable future, you should not trust any scientific statements from the FDA,” Kirsch said.
‘High-profile departures’ of members of ‘COVID-era dissent class’
In recent weeks, a growing number of key FDA officials have been fired or resigned:
Makary resigned last week, after it was rumored that the Trump administration would fire him. Kyle Diamantas, the previous FDA deputy commissioner for food, replaced Makary as acting director of the FDA. Donald Prater will replace Diamantas in his former position, Bloomberg reported.
Katherine Szarama, CBER’s acting director, left following Prasad’s departure. Reuters reported that Karim Mikhail replaced Szarama. According to STAT, Mikhail was previously a senior adviser in the FDA’s Office of the Commissioner. Szarama will remain at the FDA “to assist with product issues.”
TrialSite News reported last week that Rich Danker, “HHS’s top spokesman,” resigned shortly after Makary’s resignation.
Jeremy Walsh, the FDA’s chief AI officer, resigned last week, STAT reported.
Many of the moves followed the appointment of Chris Klomp as HHS’ No. 2 official, Reuters reported. Klomp “has since helped bring in new nominees for top health positions.”
But according to TrialSite News, several of the people involved in these “high-profile departures” were “associated — directly or symbolically — with the COVID-era dissent class” — and Klomp directed the personnel changes on behalf of the White House.
“Klomp has been helping orchestrate a quieter restructuring campaign designed to replace controversial reform-oriented figures with more conventional administrative personnel,” TrialSite News reported.
According to TrialSite News, it’s all part of a battle over whether MAHA “was ever truly intended to govern the federal health apparatus — or merely useful as a populist insurgency during campaign season.”
The Washington Post suggested the changes are related to Trump administration concerns over the looming congressional midterm elections.
“More than a year into Kennedy’s tenure, Trump officials have increasingly swapped out his handpicked deputies for people with more traditional experience, seeking to tamp down the health agencies’ controversies ahead of this year’s midterm elections,” the Post reported.
HHS: White House remains ‘fully aligned’ with MAHA
Hilliard told the Post that HHS and the White House remain “fully aligned” on MAHA. But Høeg told MD Reports she fears recent personnel changes may signal an FDA shift toward a stance more favorable to Big Pharma. “I think that’s probably one of the strategies,” she said.
Dr. Clayton J. Baker, an internal medicine physician, said Høeg’s removal may be related to growing dissatisfaction within the FDA’s ranks over Makary’s performance as commissioner.
“I believe it was determined that the FDA was not functioning effectively under Makary’s leadership, and that a change was felt to be indicated,” Baker said. Høeg’s ouster then became “collateral damage” to Makary’s departure.
Baker said it’s too early to judge whether these moves will hurt the MAHA agenda.
“I am actually hopeful for the MAHA agenda in light of the news of Dr. Makary’s departure,” Baker said. “The net result will be largely dependent upon the performance of his successor. We should be reminded that the replacement at CDC of Susan Monarez by Jim O’Neill, however temporary, proved to be salutary in multiple respects.”
Høeg’s firing comes just days after the Times reported that Kennedy is overseeing an internal, multi-agency push to study vaccine safety, including the safety of the childhood vaccination schedule.
Related articles in The Defender
White House Plans to Fire FDA Chief Marty Makary, Sources Tell WSJ
RFK Jr. Leading ‘Intense,’ Multi-Agency Study on Childhood Vaccine Safety, New York Times Reports
Federal Government Appeals Ruling in AAP Lawsuit that Struck Down RFK Jr.’s Vaccine Policies
Leaked Memo: FDA Confirms ‘At Least’ 10 Child Deaths From COVID Vaccine, Promises Sweeping Reforms
Dr. Vinay Prasad Exits Top FDA Vaccine Post After Less Than 3 Months
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