EXCLUSIVE: FDA official Tracy Høeg fired after refusing to resign

Høeg says she first learned about rumours of her departure through media reports before being told by FDA officials to resign or be terminated.

Just days after the resignation of former FDA Commissioner Marty Makary, one of his closest allies says she was summoned to her office and told to resign or be fired.

Dr Tracy Beth Høeg — the physician-scientist who became one of the most visible figures in the FDA’s post-Covid reform movement — says she first learned about her apparent departure through media reports.

At the time, she dismissed the reports as ‘rumours’ because nobody inside the agency had told her anything.

Then, hours later, two FDA officials arrived at her office and told her she could either resign or be terminated.

Høeg refused to resign.

“I said I didn’t want to resign,” Høeg told MD Reports in an exclusive interview. “I said I’m not signing a letter of resignation if it’s not my choice.”

The officials — whom Høeg declined to identify — then informed her she would no longer be working at the agency.

“They made it clear that it wasn’t their decision,” she said. “They said it was from someone above them, from someone way above their pay grade.”

Høeg said the encounter was emotional for everyone involved.

“They were both actually quite sad,” she said. “It was a very emotional goodbye.”

The extraordinary account provides a rare glimpse into the turmoil now engulfing the FDA following Makary’s departure and the collapse of what many had seen as an attempt to reform the agency from within.

Høeg had most recently been serving as Head of the FDA’s Center for Drug Evaluation and Research (CDER), one of the agency’s most powerful divisions overseeing prescription drugs.

Before that, she worked closely with Makary and former senior FDA official Vinay Prasad during efforts to reshape vaccine oversight and broader regulatory policy after the Covid era.

The appointments of Makary, Prasad, and Høeg had been closely watched internationally because they appeared to challenge the FDA’s traditional culture and instead, push for stricter scrutiny of pharmaceutical products, particularly vaccines.

Now, within weeks, all three are effectively gone.

Høeg says she believes her removal was connected.

“I suspected it was coming after Marty [Makary] resigned, because I think they didn’t want to have the people there who were closest to him anymore,” she said.

Despite the dramatic ending, Høeg spoke warmly about her time inside the agency and strongly rejected portrayals that the FDA had descended into dysfunction under Makary’s leadership.

“The chaos did not come from within the FDA,” she said. “The chaos came from the media creating stories about things being chaotic.”

According to Høeg, the environment inside CDER was collaborative, highly scientific, and deeply mission-driven.

“It was honestly a wonderful job,” she said. “I worked with wonderful people, and I felt like we were getting a lot of important work done.”

She described career scientists working long hours under intense public scrutiny while receiving little public recognition for their efforts.

“I was so pleasantly surprised by the quality of work the scientists are doing and how hard they work without ever getting recognition,” she said.

“It was incredibly fulfilling,” she added. “I wouldn’t have resigned from it.”

Still, Høeg acknowledged that persistent leaks inside parts of the agency created distrust and steadily poisoned the atmosphere.

“It became difficult to work under those circumstances because it’s hard to trust some of the people you’re working with if they’re leaking,” she said.

Høeg said pressure from industry was constant and often came indirectly through senior management or media narratives surrounding regulatory decisions.

“It’s like phone calls, text messages, pressure from above,” Høeg said. “There are situations where you feel you might lose your job because you’re making people above you unhappy.”

Høeg said she and her colleagues believed they were trying to protect scientific standards inside the agency despite mounting external pressure.

“I think we were committed to sticking to the science,” she said. “We did not want to give into political pressures if it was going to mean making dangerous decisions for public health.”

She added: “Marty and I, and Vinay [Prasad] as well, I think we all leave holding our heads high because we refused to bow to political pressure and to pressure from lobbyists to do things in order to keep our jobs or protect our reputations.”

While Høeg became publicly associated with contentious debates surrounding mRNA Covid-19 vaccines during her time in the FDA’s biologics division, she later moved to CDER where her focus shifted toward broader drug regulation.

There, she says, she became proud not only of products the agency approved, but also of products it refused to approve.

Høeg pointed to faster drug review times, the approval of several therapies for rare diseases, initiatives aimed at reducing animal testing, and efforts to draw attention to safety concerns surrounding SSRI use during pregnancy.

But she said some of the agency’s most important work involved resisting pressure to approve drugs when reviewers believed the evidence was inadequate.

“I was really proud of what we did in CDER — that we held our ground,” she said. “If we didn’t feel like it met the level of evidence for approval, we didn’t give into those pressures.”

Now, with Makary gone, Prasad departed, and Høeg herself abruptly removed, she fears the FDA may drift back toward leadership more acceptable to industry interests.

“I think that’s probably one of the strategies,” she said, when asked whether reform-minded officials were being replaced by figures seen as less confrontational toward pharmaceutical companies.

For now, Høeg says the speed of events has left her still trying to process what happened.

“I’m not sure what’s next,” she said. “I’m just trying to figure it out.”

For the officials who entered the FDA promising reform after Covid, the experiment now appears to be ending almost as abruptly as it began.

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