BY SRH
Within three months of firing Tracy Beth Høeg, its top drug regulator, the FDA had approved the first mRNA flu shot, cleared a Sanofi diabetes treatment for children that she had held up, and approved a twice-rejected melanoma drug whose maker went to the White House.
“I’m worried about approvals that we’ve seen recently, like the mRNA influenza vaccine,” Høeg told journalist Paul Thacker in an interview posted Wednesday, citing “very concerning safety issues.”
Of the melanoma drugmaker’s White House meeting, she said: “I guess that’s what you do now if you’re angry that your product is not approved. One has to wonder, is it approved based on the data or do they just know the right people?”
Høeg still doesn’t know who ordered her firing. When agency lawyers came to her office on May 15, three days after Commissioner Marty Makary was pushed out, she refused to resign. The lawyers told her the order came from “someone way above their pay grade.”
The person who supposedly wrote her termination memo denies writing it or ever seeing it, she says. Health Secretary Robert F. Kennedy Jr. only learned of the firing after she was gone, the New York Times reported.
Thacker told Høeg his sources inside the Department of Health and Human Services say Chris Klomp effectively runs the department. The White House installed Klomp, the Medicare director, as HHS chief counselor in February. He also helped negotiate the administration’s pricing deals with drugmakers.
Those sources say Klomp pushed out Makary and “probably” Høeg too, and that CEOs “have Chris Klomp on the phone all the time.” “You’re not the first person to suggest that to me,” Høeg replied.
The day Høeg was fired, Reuters reported that Klomp was leading a push to clear controversial appointees out of the FDA. HHS told Reuters it does not comment on personnel matters.
Makary resigned on May 12 after other administration officials forced through flavored-vape authorizations he had opposed, CBS News reported. Politico reported that Kennedy made the final call on pushing him out. Drugmakers had soured on the agency’s reversals on experimental drugs and vaccines and wanted a more predictable FDA, according to NPR.
Klomp’s nomination as Kennedy’s deputy cleared the Senate Finance Committee 15-12 last Thursday and awaits a floor vote. “I’m responsible for personnel, among other things,” he told senators this month.
The mRNA shot
In February, with Makary leading the FDA and Vinay Prasad running its vaccine center, the agency refused even to review Moderna’s application. About two weeks later, it reversed course and agreed to take it up.
Prasad left at the end of April, followed by Makary on May 12 and Høeg three days later. In June, the FDA’s outside vaccine advisers voted unanimously to recommend the shot. On Aug. 5, the agency approved it as mFlusiva for adults 50 and older.
Moderna’s trial of more than 40,000 adults found that the shot cut the odds of flu-like illness by 27% compared with a standard-dose vaccine. Neither the company nor FDA staff reviewers identified new or serious safety concerns. Approval for those 65 and older is conditional on a follow-up study.
“I don’t think we can say that the benefits outweighed the harms,” Høeg said, adding that she would probably detail her concerns later.
Held up, then approved
Sanofi’s Tzield was first approved in 2022 to delay the onset of clinical type 1 diabetes in patients with early-stage disease. In October, Sanofi’s bid to extend its use to newly diagnosed patients 8 and older entered Makary’s new voucher program, which promises reviews in one to two months.
Career staff recommended approval, but Høeg disagreed, and Sanofi pulled the drug out of the fast-track program. The FDA missed its April 21 goal date, STAT reported.
On June 12, four weeks after Høeg was fired, the FDA granted Tzield accelerated approval for newly diagnosed patients 8 to 17. The decision was based on its effect on C-peptide, a marker of the body’s own insulin production, rather than on a clinical outcome. No outside advisory committee weighed in. The drug’s known risks include cytokine release syndrome and viral reactivation.
“That was supposed to go to an advisory committee,” Høeg said. “And that’s a drug that’s given in children. And if you look at the pivotal clinical trial at that stage of the disease, there’s no clear evidence of clinical benefit for these children with type 1 diabetes.” Sanofi is running a confirmatory trial to support full approval.
A meeting at the White House
The FDA rejected Replimune’s RP1, an engineered virus injected into melanoma tumors, in July 2025 and again in April. After the second rejection, the company took its case to the White House in early May, arguing that the decisions clashed with the administration’s push to help terminally ill patients. The White House then pressed health officials to take another look, the Wall Street Journal reported. The White House declined to comment to the Journal.
On May 29, two weeks after Høeg was fired, Replimune announced that it would try a third time. Company officials had met with FDA and White House officials two days earlier. Its shares jumped as much as 70% in premarket trading.
In briefing documents, FDA reviewers argued that the way Replimune designed the trial and measured responses made it difficult to separate RP1’s effect from that of Bristol Myers Squibb’s Opdivo, which patients also received. The trial had no control arm. An outside panel sided with the company 10-3 on July 30. On Aug. 6, the FDA granted accelerated approval. Replimune set the list price at $450,000 per course.
“It went against everything the career staff had said about the limitations in the data,” Høeg said.
Whose report was it?
Høeg’s reputation as an mRNA skeptic dates to the pandemic. A 2021 study she led concluded that, for healthy teenage boys, the rate of heart inflammation after a second dose exceeded their four-month risk of being hospitalized with COVID. At the FDA, she reviewed reports of children who died after COVID vaccination and asked why the findings had never been made public.
Prasad’s Nov. 28 memo, which set off the uproar, credited career staff in the FDA’s pharmacovigilance office with finding that at least 10 children had died “after and because of” vaccination. When Høeg was fired, The Hill reported that she helped author the report, while CBS News reported that she helped write Prasad’s memo. It was “the career staff, not me” who linked the 10 deaths to the vaccine, Høeg said.
The final staff review, dated Dec. 5 and made public by Sen. Ron Johnson in May, examined 96 pediatric deaths reported from 2021 to 2024. It rated two “probably” and five “possibly” related to vaccination. None was rated definitively related.
Johnson later released drafts showing how the assessment had changed. Høeg suggested that staff who had handled the cases for years had a vested interest in the deaths not coming to light. “Why are we sitting on them for years if they’re concerning?” she asked. ZeroHedge detailed the fight over the review in May.
Still on sale
Tavneos is still on sale in the US, five months after Høeg’s drug center moved to pull it. Amgen’s pill for a rare autoimmune disease of the blood vessels was approved in 2021 on the strength of a single pivotal trial. The FDA had told its developer that the trial had to show the drug beat steroids at 52 weeks.
In January, the FDA asked Amgen to withdraw it voluntarily. Amgen declined. In April, the agency formally proposed withdrawal, saying unblinded study personnel had manipulated the trial’s results and the application contained untrue statements of material fact. The FDA has also linked the drug to 76 cases of liver injury, including eight deaths.
On June 26, Europe’s medicines committee recommended revoking the drug’s license. Three days later, the New England Journal of Medicine retracted the pivotal trial at the request of its two academic authors. The journal said nine patients’ results had been re-adjudicated after the data were unblinded, without the authors’ knowledge. Britain stopped new patients from starting the drug in September.
“People have died taking this drug and we don’t know if it works,” Høeg said.
Amgen, which acquired the drug’s developer, ChemoCentryx, for $3.7 billion in 2022, says it strongly disagrees with the proposal and has requested a hearing. It points to an independent re-analysis from Duke that it says supports the drug’s efficacy.
Its own prescriber page states that superiority “was not demonstrated at week 52.” Tavneos brought in $459 million last year, and first-quarter US sales rose 32% to $119 million.
Under federal law, the drug stays on the market until the FDA commissioner rules on Amgen’s hearing request and on withdrawal. Since May, the agency has been led by acting commissioner Kyle Diamantas, a lawyer who oversaw food regulation. Trump’s pick for the permanent job, White House aide Heidi Overton, had her confirmation hearing last week and is awaiting a vote. Source: ZeroHedge
