Exclusive: FDA staff fear Tracy Beth Høeg will bring bias, instability to drug center

A STAT Examination

FDA staff fear Tracy Beth Høeg will bring bias and instability to embattled drug center

By Lizzy Lawrence

Photo illustration: Alex Hogan/STAT; Screen capture via YouTube

On Monday, Tracy Beth Høeg will become acting director of the FDA's drug center. But her track record as scientific adviser to Commissioner Marty Makary has raised questions about her ability to oversee drug regulation without bias.

Already, Høeg has taken steps to limit access to Covid shots, to cut career staff out of vaccine surveillance research, and to revisit the safety of monoclonal antibodies that protect infants against RSV. She is seeking radical change, often based on thin evidence.

"She is interpreting reality in a way that supports what she already believes," said a drug center official who has worked with Høeg.

Staffers, as well as industry and patient stakeholders, desperately want the drug center to be stable again after months of personnel upheaval. Based on STAT's reporting, Høeg may not bring that stability.