The appointment of Dr. Tracy Beth Høeg as acting director of the FDA’s Center for Drug Evaluation and Research has raised significant concerns among senior officials at the Food and Drug Administration. Following the unexpected resignation of Richard Pazdur, who held the position for only three weeks, Høeg’s selection has been described by some as “like dropping an atom bomb” within the agency, according to sources familiar with the situation.
Høeg, a sports medicine physician and epidemiologist, has been a contentious figure due to her previous stance on vaccines. She has reportedly influenced FDA vaccine policy since joining the agency in March 2023. Her recent advocacy to limit COVID-19 vaccinations for young men, based on potential risks of myocarditis, has drawn criticism from various quarters.
In her statement upon appointment, Høeg emphasized her commitment to “transparency, honesty, and decisions based on rigorous science.” Yet, her qualifications for overseeing the FDA’s critical drug approval processes are under scrutiny. Sources within the FDA have indicated that there is widespread apprehension regarding her ability to lead an office responsible for ensuring the safety and effectiveness of both over-the-counter and prescription medications.
Concerns Over Leadership Changes
Høeg’s ascendance comes during a tumultuous period for the FDA, which has experienced multiple leadership changes this year. The abrupt departure of Pazdur, a respected veteran in the field, was reportedly due to tensions with FDA Commissioner Marty Makary. This instability has left many within the agency questioning its direction and integrity.
A spokesperson from the Department of Health and Human Services did not provide comments on Høeg’s qualifications when approached for clarification. A dozen former FDA leaders have publicly denounced proposed changes to vaccine policy that Høeg endorsed, arguing that they threaten to undermine the FDA’s regulatory model designed to ensure vaccine safety and availability.
The memo outlining these policy changes, which claimed that at least ten children died “after and because of” receiving the COVID-19 vaccine, lacked supporting data, prompting further scrutiny. The HHS has indicated that data related to these claims will be released soon.
Impact on Drug Development and Public Trust
There is growing fear that Høeg’s leadership may politicize the FDA, leading pharmaceutical companies to perceive the agency as an unreliable partner in drug development. A senior official expressed concerns that companies might opt to develop new products overseas, seeking a “more stable” regulatory environment.
During a recent meeting with the Centers for Disease Control and Prevention advisory panel, handpicked by Health Secretary Robert F. Kennedy Jr., Høeg questioned the U.S. childhood vaccination schedule. She suggested that the U.S. may be an “international outlier” in its vaccine recommendations, prompting backlash from experts who maintain that U.S. guidelines are based on robust evidence and are largely consistent with those of other developed nations.
Høeg acknowledged the importance of vaccines, particularly in light of recent measles outbreaks predominantly affecting unvaccinated populations. Her comments reflect a complex position within the broader conversation about public health and vaccine hesitancy.
As Høeg steps into her new role, she faces the daunting task of restoring confidence in the FDA amidst declining trust in the U.S. health care system, a sentiment that has been exacerbated by the COVID-19 pandemic and ongoing political polarization.
