Tracy Beth Hoeg will be fifth CDER head this year
Tracy Beth Høeg is making the switch from CBER, where she has been working as senior advisor for clinical sciences in the Office of the Commissioner.
FDA Commissioner Marty Makary has appointed Tracy Beth Høeg as acting director of the Center for Drug Evaluation and Research (CDER), after news emerged of the retirement of Richard Pazdur.
Høeg, a sports medicine physician and epidemiologist with little in the way of experience in medicines regulation, will make the switch to CDER from the Center for Biologics Evaluation and Research (CBER), where she has been working as senior advisor for clinical sciences in the Office of the Commissioner.
She will assume the top job at CDER just a few weeks after long-serving and respected FDA figure Pazdur took on the role, vacated after his predecessor George Tidmarsh stepped down – again after mere weeks – amid concerns about his personal conduct.
There have been two other CDER directors this year, namely Patrizia Cavazzoni – who stepped down just before the Trump administration started a second term – and Jacqueline Corrigan-Curay, who, like Pazdur, announced her retirement shortly after being appointed.
The rapid turnover in leadership prompted the president and chief executive of the Biotechnology Innovation Organization (BIO), John Crowley, to remark that the "constant turmoil" at CDER "is undermining America's leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China."
The appointment of Høeg – who has a history of vaccine scepticism and, like Makary, opposed COVID-19 policies during the pandemic – may not restore confidence anytime soon. She led a controversial investigation into the safety of COVID-19 vaccines, focusing on deaths in children, which looks like it could usher in a tougher regulatory environment for vaccines that has been roundly criticised by former FDA Commissioners.
In a statement, Makary said that Høeg "is the right scientist to fully modernise CDER and finish the job of establishing a culture of cross-centre coordination there. At CBER, she advanced scientific rigour through her commitment to providing the public with the highest quality of evidence, including our roadmap to reduce and replace animal testing with new technologies."
Office of Nonprescription Drugs change
In yet more disruption among the FDA's senior leadership, it has also emerged that Terri Michele, long-serving director of the Office of Nonprescription Drugs (ONPD), has been moved to a new role at the FDA's medical devices centre, according to Stat, which suggested the move resulted from a switch in ONPD focus to affordability.
Shortly after, the FDA confirmed that deputy director Karen Murry will take over at ONPD and "lead its efforts to deliver affordable over-the-counter options to the American people."
