- The FDA fired acting drug chief Tracy Beth Høeg on May 15, and she still doesn't know who ordered it.
- HHS sources point to top official Chris Klomp, whom drug company CEOs reportedly call constantly.
- By August, the FDA approved an mRNA flu shot Høeg says raises very concerning safety issues.
- A children's diabetes drug she held up and a twice-rejected, White House-lobbied melanoma drug also won approval.
- Tavneos, tied to eight deaths and alleged trial manipulation, remains on the U.S. market.
The Food and Drug Administration mysteriously ousted Tracy Beth Høeg as acting director of its drug evaluation center on May 15. By August, the agency had approved an mRNA flu shot she openly questioned, a children's diabetes drug she had held up, and a melanoma treatment its own career staff doubted. She still does not know who ordered her firing, but sources point to a White House-installed counselor with close ties to pharmaceutical executives.
Asked to resign three days after Commissioner Marty Makary stepped down, Høeg refused. Agency lawyers said the decision came from "someone way above their pay grade." The official named on her termination memo has since disowned it, she says, and Health Secretary Robert F. Kennedy Jr. learned of the firing only afterward, according to the New York Times.
Journalist Paul Thacker told Høeg that his HHS contacts point to Chris Klomp, the Medicare chief who also became HHS chief counselor in February, as the likely architect. Those sources say pharmaceutical CEOs "have Chris Klomp on the phone all the time." When Thacker relayed that Klomp had likely pushed her out, Høeg replied, "You're not the first person to suggest that to me."
mRNA flu vaccine approved despite former drug chief's safety concerns
In February, under Makary and vaccine center director Vinay Prasad, the FDA would not even accept Moderna's mRNA flu shot application for review, only to reverse itself about two weeks later. By mid-May, all three officials were gone, and on Aug. 5, mFlusiva won approval for adults 50 and older.
In a trial of more than 40,000 people, Moderna's shot reduced the odds of flu-like illness by 27% versus a standard-dose vaccine. Agency reviewers and the company flagged no new or serious safety concerns, though approval for those 65 and older hinges on a follow-up study.
Høeg told Thacker the shot raises "very concerning safety issues." "I don't think we can say that the benefits outweighed the harms," she said.
Sanofi diabetes drug approved for children without advisory panel meeting
Career staff supported extending Sanofi's Tzield to newly diagnosed patients 8 and older under Makary's fast-track voucher program, but Høeg objected. Sanofi withdrew from the fast track, and the agency blew past its April 21 deadline, STAT reported.
On June 12 — less than a month after Høeg's firing — the FDA granted accelerated approval for newly diagnosed children 8 to 17, based on a marker of insulin production rather than clinical outcomes. The drug, which carries risks including cytokine release syndrome and viral reactivation, never went before outside advisers.
"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."
Twice-rejected melanoma drug wins approval after maker lobbies White House
Replimune's RP1, a modified virus injected directly into melanoma tumors, failed twice before the FDA — in July 2025 and again in April. The company then appealed to the White House, which leaned on health regulators to take another look, the Wall Street Journal reported. Replimune announced a third attempt on May 29, two weeks after Høeg left.
FDA reviewers had argued the trial's design made it hard to tell how much of the benefit came from RP1 rather than Opdivo, a second drug patients received. An outside panel nonetheless voted 10-3 in the company's favor, and the FDA granted accelerated approval Aug. 6. Replimune has priced it at $450,000 per course.
"It went against everything the career staff had said about the limitations in the data," Høeg said. On the White House lobbying, she added: "One has to wonder, is it approved based on the data or do they just know the right people?"
Drug linked to eight deaths still sold in U.S.
Tavneos, an Amgen pill for a rare autoimmune disease, remains on the U.S. market despite her center's move to pull it over alleged trial manipulation. Europe revoked the drug's license in August. The FDA has also tied it to 76 cases of liver injury, including eight deaths. "People have died taking this drug and we don't know if it works," Høeg said. Amgen disputes the allegations and has requested a hearing. Until the FDA commissioner rules, patients will keep taking a medication the agency itself says rests on manipulated data, while the official who tried to pull it is out of a job.
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