FDA Leadership Shakeup: Top Drug Regulator Departs Amid Political Turmoil
The U.S. Food and Drug Administration faces significant instability as Dr. Tracy Beth Høeg, acting director of the Center for Drug Evaluation and Research, departs just days after Commissioner Marty Makary’s resignation. This leadership crisis, occurring under the second Trump administration, stems from internal conflicts over flavored e-cigarette access and controversial vaccine safety reviews. With multiple high-level exits and temporary appointments, the agency grapples with intense political pressure from administration allies, raising concerns about regulatory integrity and public trust in federal health oversight.
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FDA Official Who Scrutinized COVID Shots and Antidepressants Removed in Agency Shake-Up
Tracy Beth Hoeg, MD, PhD, has been removed from her position as acting director of the FDA’s drug center, marking the latest leadership change at the agency. Hoeg, who stated she was fired, was replaced by Mike Davis, MD, PhD, the former deputy director. Her departure follows the recent resignation of FDA Commissioner Marty Makary and the earlier exit of vaccine chief Vinay Prasad, amid significant pressure from political allies of President Donald Trump, including anti-abortion groups and vaping lobbyists. Hoeg, a close ally of Makary and Health Secretary Robert F. Kennedy Jr., had led investigations into the safety of antidepressants, RSV drugs, and COVID-19 vaccines since December. A critic of pandemic-era mandates, Hoeg lacked prior government management experience before her rapid promotion. During her tenure, she supported efforts to remove certain childhood vaccines from federal recommendations, a move currently blocked by a federal court. The shake-up reflects ongoing tensions between the FDA leadership and various industry and political stakeholders regarding regulatory direction and vaccine safety assessments.
MedPageToday.com - medical news for physiciansRFK Ally Dr. Tracy Beth Hoeg Confirms Dismissal from FDA Drug Center Role
Dr. Tracy Beth Hoeg, an ally of Health Secretary Robert F. Kennedy Jr. and former FDA Commissioner Marty Makary, has confirmed her dismissal as the acting director of the FDA’s drug center. She stated she leaves with no regrets after learning significantly during her tenure. Hoeg is being replaced by Dr. Mike Davis, the former deputy director. This departure marks the latest in a series of high-profile leadership changes at the agency, following the recent resignation of Commissioner Makary and vaccine chief Dr. Vinay Prasad. Hoeg, a sports medicine physician with no prior government management experience, was rapidly promoted by Makary to lead investigations into the safety of COVID-19 vaccines, antidepressants, and RSV drugs. Her appointment and subsequent removal reflect intense political pressure on the FDA from President Donald Trump’s allies, including anti-abortion groups and vaping lobbyists, who criticized the agency's direction. Hoeg was also instrumental in efforts to remove certain childhood vaccines from federal recommendations, a move currently blocked by a federal judge. The shake-up underscores the significant ideological shifts occurring within the regulatory body under the current administration.
Fortune | FORTUNEControversial FDA Drug Center Head Dr. Tracy Beth Høeg Resigns Amid Agency Shake-up
Dr. Tracy Beth Høeg, the acting director of the FDA's Center for Drug Evaluation and Research (CDER), is leaving her position, marking another high-level departure at the agency. A senior FDA official confirmed the news to CBS News, following reports by Reuters. Høeg, who assumed the role in December, previously advised former FDA Commissioner Dr. Marty Makary. Her exit comes just three days after Makary resigned amid internal conflicts, particularly regarding the controversial approval of flavored e-cigarettes under administrative pressure. This departure follows the recent exit of Dr. Vinay Prasad, another senior official. Høeg's tenure was marked by significant controversy due to her history of vaccine skepticism, including involvement in efforts to reduce recommended childhood vaccines and authoring a memo linking children's deaths to COVID-19 vaccines without sufficient data. Her appointment had previously alarmed senior FDA officials, with one source comparing it to dropping an atom bomb. Despite the backlash, Høeg had stated her commitment to rigorous science and transparency upon her confirmation. The series of resignations highlights ongoing instability and ideological tensions within the FDA leadership.
Home - CBSNews.comFDA Replaces Top Drug and Biologics Leaders Amid Leadership Shakeup
The U.S. Food and Drug Administration (FDA) has implemented significant leadership changes within its key regulatory divisions, replacing the heads of the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This restructuring follows the recent departure of FDA Commissioner Marty Makary, marking a tumultuous period for the agency under the second Trump administration. According to an internal memo, acting directors Tracy Beth Høeg and Katherine Szarama have been removed from their posts. Karim Mikhail will assume leadership at CDER, while Michael Davis takes over at CBER. Lowell Zeta has been appointed as the new acting chief of staff. The shakeup highlights ongoing instability, with Davis becoming the fifth person to lead CDER since January. The Trump administration is currently working to fill several critical health vacancies, including the CDC director and Surgeon General positions, and aims to nominate a permanent FDA commissioner in the coming weeks for Senate confirmation.
US Top News and AnalysisFDA Shakeup Continues as Top Drug Regulator Departs Days After Agency Chief Resigns
Dr. Tracy Beth Høeg is stepping down as the head of the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), marking another significant leadership change within the agency. Her departure comes just days after the resignation of FDA Commissioner Marty Makary, who left his post following disagreements with the Trump administration over the expansion of access to flavored e-cigarettes. Høeg, a sports medicine doctor known for her criticism of COVID-19 vaccines for children during the pandemic, served as acting director for approximately five months. She was the fifth individual to occupy this role during the second Trump administration and previously served as a special assistant to Makary. Michael Davis, the deputy center director at CDER, has been appointed as the new acting director, while Kyle Diamantas, the FDA’s top food regulator, will temporarily assume Makary’s responsibilities. The Department of Health and Human Services stated that it is actively seeking experienced candidates to fill key leadership positions to strengthen agency operations and maintain public trust, asserting that the FDA continues to operate under solid leadership in the interim.
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