FDA Chief: Trust Eroded by Absolute Health Guidance

FDA Commissioner Martin Makary has called for greater governmental humility and transparency to restore public trust in health guidance, which he feels has significantly diminished since the pandemic. He pointed to a recent FDA memo that, while not releasing new information, cited rare reports of child deaths associated with COVID-19 vaccines.

Makary expressed concern that officials failed to adequately communicate how risks associated with vaccines varied across different age groups and individuals with underlying health conditions. He argued that issuing recommendations with absolute certainty, especially when the supporting data is not extensive, can be detrimental to public confidence.

Furthermore, Makary noted the FDA's application of scientific thresholds, such as not approving an mRNA flu shot due to a lack of benefit in trials. He also suggested that the rigid recommendation for the hepatitis B vaccine for infants born to negative mothers, given within hours of birth, exemplifies an "absolutism" that can undermine trust, advocating for more flexibility where science permits.