Doctors Sound Alarm Over Incoming FDA Adviser Tracy Beth Høeg

A Surprising Nomination

When the White House announced that Danish-American sports-medicine researcher Tracy Beth Høeg would join the U.S. Food & Drug Administration as senior adviser on drug safety, the news barely dented the weekend cycle. Forty-eight hours later, a letter signed by more than 300 physicians, pharmacologists, and biostatisticians landed on Capitol Hill, arguing that Høeg’s résumé is “alarmingly thin on the pharmacovigilance expertise demanded by the post.”

Inside the Letter of No-Confidence

The correspondence, spearheaded by former FDA deputy commissioner Dr. Lila Moreau, claims Høeg’s peer-reviewed work focuses almost exclusively on musculoskeletal injury patterns in recreational runners—not on randomized drug trials, post-market surveillance, or the statistical modeling that underpins FDA rulings.

“We welcome fresh perspectives,” Moreau told reporters Tuesday, “but this role shapes decisions on every prescription bottle in America. The learning curve is Everest.”

What the FDA Actually Does—and Why It Matters

• Oversees approval of all prescription drugs sold in the United States.
• Monitors adverse-event reports from hospitals, manufacturers, and patients.
• Can pull a medication from the market if risks outweigh benefits.

A misstep, critics warn, can ripple through global supply chains and insurance formularies within weeks.

The Runner-Researcher Who Became a Culture-War Fixture

Høeg, 42, vaulted from relative obscurity to social-media prominence during the pandemic, questioning school-mask mandates in The Atlantic and on Joe Rogan’s podcast. Conservative circles praised her contrarian streak; many academics called her interpretations “selective.”

Her 2021 BMJ paper on myocarditis after mRNA vaccination remains among the journal’s most downloaded, though independent analyses later found the incidence rate was lower than Høeg’s team estimated. Critics now fear that track record could color agency judgments on booster campaigns or gene therapies.

What Høeg Says

Reached in Sacramento, where she still sees weekend warriors at a sports-clinic, Høeg declined an on-camera interview but emailed a statement:

“My career has been about translating data into better health decisions. If confirmed, I will surround myself with world-class scientists and lean on evidence, not ideology.”

Confirmation Clock Ticks

The Senate Health Committee has scheduled hearings for late October. Democratic staffers say they will probe whether Høeg can “speak the language” of Kaplan-Meier survival curves and Bayesian safety signals. Republicans frame the scrutiny as “elite gatekeeping.”

Markets are watching: biotech shares dipped 2.4% on the controversy, with investors wary of delayed drug approvals if bipartisan gridlock stalls the post.

Voices from the Clinics

Dr. Ana Castillo, a family physician in Phoenix, says the FDA’s credibility already wobbled after the controversial Aduhelm approval. “Patients ask me, ‘Are your regulators scientists or politicians?’” she sighs. “I don’t want to guess.”

What Happens Next

If confirmed, Høeg would replace Dr. Jacqueline Corrigan, a 17-year FDA veteran who streamlined post-market safety reviews. Staffers whisper that morale inside the agency’s Center for Drug Evaluation and Research is “brittle,” with some reviewers updating LinkedIn profiles.

Meanwhile, Moreau’s coalition vows to keep lobbying, armed with a 38-page dossier dissecting Høeg’s publication metrics. “This isn’t personal,” Moreau insists. “It’s about keeping Americans safe.”

Whether that argument resonates in the hearing room may decide not just one career, but the speed at which the next generation of therapies reaches pharmacy shelves.