Today’s Food and Drug Administration seems to be of two very different minds about oversight. For some things like vaccines, even strong data apparently are not good enough. But for other products, the FDA is signaling that relatively little data will be needed. This dualism seems driven more by ideology than biomedical science, so it presents big risks to patients and the field.
The dichotomy came to mind again when I heard that Tracy Beth Høeg was appointed the new acting director of the Center for Drug Evaluation and Research (CDER). In that role, she will be responsible for policy and oversight of most drugs in the U.S. I see reasons to worry about Høeg leading CDER, including what I see as her past inconsistencies.
Høeg’s been highly critical of Covid vaccinations and precautions, arguing they often do more harm than good, particularly for certain groups. Other experts on immunization have strongly disagreed with her about the data.
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