Top FDA Drug Official Removed Amid Agency Shake-Up
Acting CDER chief Tracy Beth Høeg was removed and replaced by deputy Michael Davis amid departures across FDA leadership and disputes over vaccines, e-cigarettes and drug safety reviews.
FOX NewsSecond FDA executive departing organization in less than a week as top drug regulator claims she was fired
CBS NewsControversial FDA official leaving drug center post in latest departure at agency
ABC NewsFDA official who scrutinized COVID shots and antidepressants is out in latest shake-up
The GuardianFDA turmoil deepens as top drug chief departs claiming she was fired
Overview
Dr. Tracy Beth Høeg was removed as acting director of the FDA's Center for Drug Evaluation and Research and said on social media that she was 'fired,' with Deputy Director Dr. Mike Davis named as her replacement, according to an FDA email to staff.
Høeg's departure follows the resignation of FDA Commissioner Dr. Marty Makary earlier in the week and comes amid a broader agency shake-up that also includes the exit or reassignment of Katherine Szarama and Chief of Staff Jim Traficant, according to reporting.
Høeg told MD Reports she refused to sign a resignation letter and said her removal came 'from someone way above their pay grade,' and agency officials have been conducting reviews of COVID-19 vaccines, antidepressants and RSV drugs, according to reporting.
Høeg led an 'initial analysis' that linked COVID-19 shots to 10 reported deaths in children and pursued reviews that include antidepressant pregnancy-risk petitions, though the FDA has not formally announced the vaccine findings, according to reporting.
The agency updated its organization chart to show Karim Mikhail at CBER and Lowell Zeta as acting chief of staff, and the administration said it hopes to name a nominee for permanent FDA commissioner in a matter of weeks, according to reporting.
Analysis
Center-leaning sources frame Høeg as a controversial, contrarian official who frequently challenged FDA consensus. They emphasize her criticism of pediatric COVID shots and vaccine-schedule work, cite HHS reassurances and reporting from Reuters and STAT, and juxtapose those claims with scientific context (e.g., aluminum-safety findings) to undercut her positions.