The Food and Drug Administration has removed Dr. Tracy Beth Hoeg from her position as acting director of the agency's drug program, marking the latest in a series of leadership changes at the influential regulatory body. Hoeg, who is closely aligned with Health Secretary Robert F. Kennedy Jr., confirmed her departure in a social media post, stating, 'I learned so much and leave with no regrets.'
Leadership Turmoil Continues
Hoeg's exit follows the resignation of FDA Commissioner Marty Makary earlier this week and the departure of Dr. Vinay Prasad, the agency's vaccine and biotech chief, last month. Dr. Mike Davis, previously deputy director, will assume Hoeg's role. Karim Mikhail, a longtime pharmaceutical executive, has been named acting director of the vaccines center.
'I learned so much and leave with no regrets.' - Dr. Tracy Beth Hoeg
Controversial Tenure
Hoeg, a sports medicine physician and public health scientist, rose rapidly through the FDA ranks after being promoted by Makary. Over her tenure, she led investigations into the safety of COVID-19 vaccines, antidepressants, and injectable RSV drugs for children. Hoeg's outspoken criticism of masking, school closures, and vaccine mandates during the pandemic drew attention before her government role. She also co-authored papers with medical contrarians who later joined the Trump administration.
Her tenure was marked by controversy, including an internal FDA memo discussing an unverified link between COVID-19 vaccines and 10 reported deaths in children. The FDA has not formally announced these findings or provided supporting evidence.
Policy Implications
Hoeg played a role in the Trump administration's effort to drop federally recommended childhood vaccines, including those for flu and hepatitis B at birth. While these changes were temporarily blocked by a federal judge, the administration plans to appeal. Hoeg's departure signals ongoing turbulence at the FDA as the agency navigates its regulatory responsibilities under new leadership.