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FDA’s Acting Drug Chief Tracy Høeg Fired Amid Leadership Crisis After Makary Exit

FDA’s Acting Drug Chief Tracy Høeg Fired Amid Leadership Crisis After Makary Exit
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The turmoil at the U.S. Food and Drug Administration deepened this week as Dr. Tracy Beth Høeg, the acting head of the agency’s powerful drug division, said she was fired on Friday, just three days after FDA Commissioner Marty Makary resigned under political and industry pressure theguardian +1. Høeg had led the Center for Drug Evaluation and Research (CDER) for only about six months; her removal leaves the agency with no permanent chief for drugs, biologics, vaccines or the agency itself, even as it oversees products representing roughly 20% of U.S. consumer spending politico +1.

In a post on X, Høeg wrote, “Today I was fired… I learned so much & leave with no regrets,” without specifying who ordered her ouster cnbc. An internal memo named Michael Davis, CDER’s deputy, as acting drug director and elevated food official Kyle Diamantas to acting FDA commissioner, part of a broader reshuffle that also removed acting vaccines chief Katherine Szarama and the agency’s chief of staff cnbc +1. The upheaval followed Makary’s abrupt resignation on May 12 after roughly 13 tumultuous months atop the agency, amid clashes over flavored e‑cigarettes, abortion pill oversight and vaccine policy nytimes +1.

A Power Struggle Over Science, Vaccines and Vaping

Høeg’s firing capped months of infighting over how far to push the Trump administration’s “Make America Healthy Again” agenda inside an agency long built around technocratic continuity nytimes. A sports medicine physician and epidemiologist, she had become a lightning rod for public‑health advocates because of her alignment with vaccine‑skeptical positions and her role in efforts to narrow the childhood immunization schedule theguardian +1. She worked closely with Makary and Health and Human Services Secretary Robert F. Kennedy Jr. on internal analyses that critics said overstated vaccine risks, including a draft report that sought to link Covid‑19 vaccines to the deaths of 10 children, and helped drive proposals to toughen vaccine approval standards axios +1.

Makary’s own downfall illustrated the competing pressures on FDA leadership. He drew fierce opposition from many career scientists and former commissioners for pushing to speed some drug reviews and weaken traditional trial requirements, while simultaneously angering Trump aides, anti‑abortion activists and parts of the vaping industry by resisting approvals for certain fruit‑flavored e‑cigarettes and moving cautiously on tightening access to the abortion pill mifepristone medpagetoday +2. “The FDA is a complete mess,” Trump complained publicly as reports circulated that he had signed off on firing Makary before the commissioner ultimately resigned ibtimes +1. Industry groups, meanwhile, blasted what they described as erratic decisions and a revolving door atop CDER and the biologics division; by some counts, the drug center has cycled through five or six leaders in about a year cnbc +1.

What Leadership Chaos Means for Drugmakers and Patients

For drug developers, the immediate impact of the purge is uncertainty. Biotech stocks jumped on early reports that Makary would be pushed out, reflecting hopes that a new regime might be more predictable after a run of surprise rejections and shifting guidance, particularly in gene therapy and rare‑disease applications wsj. Yet Friday’s reshuffle underscored that there is still no Senate‑confirmed commissioner, no permanent heads of CDER or the biologics center, and no clear signal about how aggressively the next leadership team will pursue Kennedy’s broader push to overhaul vaccine policy and tighten scrutiny of certain therapeutics cnbc +2.

Public‑health experts warned that the combination of rapid turnover, politically charged vaccine debates and contested internal analyses risks eroding public trust in the FDA’s scientific independence at a time when the agency may soon face decisions on updated Covid shots, new mRNA flu vaccines and treatments fast‑tracked under Trump’s recent executive order on mental‑health drugs axios +1. Senior senators from both parties have voiced concern that prolonged vacancies across federal health posts — including at the CDC and within HHS — could slow responses in the next public‑health emergency and complicate routine oversight of food, drugs and medical devices thedispatch.

The Bigger Picture

The firing of the FDA’s top drug regulator, on the heels of the commissioner’s forced exit, highlighted how deeply partisan and ideological battles have penetrated an agency that once prided itself on staying largely above politics. With interim leaders now steering every major branch of the FDA, the next commissioner’s mandate will be less about setting new policy than restoring basic stability — convincing career scientists, pharmaceutical companies and a skeptical public that drug and vaccine decisions are being made on evidence, not on whoever last won a fight in the West Wing.