Article Summary:
The Trump administration’s appointment of Dr. Tracy Beth Høeg, a vaccine skeptic, as the acting director of the FDA’s Center for Drug Evaluation and Research has raised alarm among senior FDA officials. They fear Høeg’s lack of experience in drug review and her controversial views on vaccines will harm the agency’s reputation as a reliable regulator of the nation’s drug supply.
Høeg has advocated for making it more difficult for young men to receive the COVID-19 vaccine due to the potential risk of myocarditis. She has also helped write a memo claiming that the FDA has found at least 10 children died “after and because of” receiving the COVID-19 vaccine, a claim not supported by data. This memo proposed changes to how the FDA handles COVID-19 and other vaccines, which former FDA leaders have denounced as undermining the agency’s role in ensuring vaccine safety and effectiveness.
In her new role, Høeg will oversee the office responsible for approving new drugs and ensuring the safety and effectiveness of all over-the-counter and prescription drugs in the U.S. Senior FDA officials fear she will politicize this science-focused office, leading companies to view the FDA as an unreliable partner and potentially choose to develop new products overseas.
The appointment comes after the abrupt resignation of a veteran FDA scientist, Richard Pazdur, who clashed with FDA Commissioner Marty Makary. Høeg’s selection as acting director is seen by some as an “extinction-level event” that will lead to further resignations within the agency.