Tracy Beth Høeg Appointed Acting Director of FDA’s CDER Amid Controversy
Tracy Beth Høeg was appointed acting director of the FDA’s Center for Drug Evaluation and Research (CDER) in 2025, becoming the fifth person to lead the center this year. Høeg, a Danish American sports physician and epidemiologist, gained prominence for questioning Covid vaccines and focusing on potential post-vaccination deaths during her tenure at the FDA.
Her appointment is seen by some as potentially tightening alignment between CDER and the FDA’s vaccine regulator, which could shift the emphasis toward reevaluating or dismantling already approved vaccines. Plans to align the US childhood vaccine schedule with Denmark’s were reportedly postponed to the new year amid these changes.
Experts have raised concerns about Høeg’s qualifications for drug regulation, noting her lack of experience in drug development, regulatory leadership, and management of large organizations. She has notably advised Florida Surgeon General Ladapo, who has been accused of data manipulation. Høeg has advocated excluding young men from Covid vaccines and published work based on crowd-sourced reports of post-vaccination myocarditis.
In presentations to the Advisory Committee on Immunization Practices (ACIP), Høeg questioned the safety of aluminum adjuvants, the data supporting the administration of multiple vaccines together, and criticized signals related to RSV vaccine safety in trials.
Her appointment has drawn criticism from twelve former FDA commissioners who signed a letter published in the New England Journal of Medicine. They argued that the FDA should maintain transparency and apply more rigorous, evidence-based processes when announcing vaccine-regulation changes.
As acting director, Høeg also inherits the FDA commissioner’s controversial priority voucher program, a fast-track one-day drug-approval initiative.
The developments under Høeg's leadership mark a significant moment of transition and debate over vaccine regulation and drug evaluation at the FDA.
