The Food and Drug Administration on Monday announced George Tidmarsh as director of its Center for Drug Evaluation and Research. File Photo by Jim Lo Scalzo/EPA-EFE
The U.S. Food and Drug Administration on Monday named ex-biotech industry exec George Tidmarsh as its chief drug regulator.
Federal officials said the appointment of Tidmarsh, an adjunct professor of pediatrics and neonatology at Stanford University’s School of Medicine, to be director of the FDA’s Center for Drug Evaluation and Research means Tidmarsh will lead its work to ensure availability of “safe, effective and high-quality drugs.”
In a statement, FDA Commissioner Marty Makary called Tidmarsh an “accomplished physician-scientist and leader” who had work experience spanning “the full arc of drug development — from bench to bedside.”
Tidmarsh, former CEO of La Jolla Pharmaceuticals, founded Horizon Pharma prior to its $28 billion buyout by Amgen, Threshold Pharmaceutical and held other senior roles in biotech firms.
He replaces the CDER’s acting head, Jacqueline Corrigan-Curay, who announced last month that she would step down.
He will oversee the FDA’s crucial division that reviews the majority of new drug applications and regulates over-the-counter medications.
The arrival at the regulatory agency comes as the U.S. Department of Health and Human Services under Secretary Robert F. Kennedy, Jr. has pursued steep cuts to staff, along with other federal departments, and onboarded others perceived lacking in relevant medical and scientific experience.
In an opinion piece in April, he signaled that he may take a more hardline approach to drug policy and was critical of regulatory decisions made by Kennedy’s former HHS staff.
Tidmarsh earned his medical degree and doctorate in cancer biology from Stanford University.
“His appointment to lead CDER brings exceptional scientific, regulatory and operational expertise to the agency,” Makary added Monday.
