FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and Research (CDER) in veteran biotech executive George Tidmarsh, M.D., Ph.D.
Tidmarsh takes over the CDER after a lengthy career in biotech and academia that saw the development of seven FDA-approved drugs, the formation of several biopharma companies and the establishment of Stanford University’s Master of Translational Research and Applied Medicine program.
Some of the biopharma companies Tidmarsh had a hand in founding and leading include Metronome Therapeutics, Revelation Biosciences and Horizon Therapeutics, which has since been picked up by Amgen for $27.8 billion. He’s been stationed at his alma mater at Stanford University’s School of Medicine for the last 15 years, most recently serving as an adjunct professor of pediatrics and neonatology.
“Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development—from bench to bedside,” Makary said in an FDA release. “His appointment to lead CDER brings exceptional scientific, regulatory, and operational expertise to the agency.”
The FDA chief looks to work with Tidmarsh to “strengthen our drug review programs, foster innovation, and advance cross-agency initiatives that improve health outcomes for the American public,” Makary added.
It’s unclear what Tidmarsh’s other priorities will be in his role, but the new CDER head has previously voiced his wishes for the FDA to “remove harmful, useless drugs from the market” and has called out instances of scientific misconduct and fraud in academic science.
Tidmarsh will take the reins from Jacqueline Corrigan-Curay, M.D., who has been serving as CDER’s acting director since its former head, Patrizia Cavazzoni, M.D., stepped down after a seven-year tenure at the FDA shortly before the start of President Donald Trump’s second term.
Corrigan-Curay, meanwhile, communicated her plan to retire last month, ensuring colleagues that she’d remain with the agency for a few weeks to oversee a smooth transition.
Tidmarsh’s appointment is the latest in a series of staffing changes to FDA leadership. The director of the agency’s cell and gene therapy office Nicole Verdun, M.D. and her deputy Rachael Anatol, Ph.D., were reportedly placed on leave last month, while the FDA’s chief medical officer Hilary Marston, M.D., hit the exit in April.
Peter Marks, M.D., Ph.D., abruptly resigned from his long-held post of director of the FDA’s Center for Biologics Evaluation and Research also in April, citing opposing vaccine views with Department of Health and Human Services Secretary Robert F. Kennedy, Jr.
Makary tapped Vinay Prasad, M.D., to replace Marks. Since then, the two have laid out changes for the FDA including a new, stricter approach to COVID vaccine approvals. Prasad and now Tidmarsh hold two of the most crucial positions on the drugs side of the FDA.