FDA Appoints Biotech Veteran George Tidmarsh as New CDER Director

The Food and Drug Administration (FDA) has named George Tidmarsh, M.D., Ph.D., as the new director of the Center for Drug Evaluation and Research (CDER). This appointment marks a significant shift in leadership at one of the agency's most crucial divisions, responsible for overseeing drug approvals and regulations in the United States.

Tidmarsh's Background and Appointment

Dr. Tidmarsh brings a wealth of experience from both academia and the pharmaceutical industry to his new role. An adjunct professor of pediatrics and neonatology at Stanford University's School of Medicine, Tidmarsh has been involved in the successful clinical development of seven FDA-approved drugs. His career spans various leadership positions, including founder and CEO roles at companies such as Horizon Pharma, La Jolla Pharmaceutical, and Threshold Pharmaceuticals.

FDA Commissioner Marty Makary praised Tidmarsh's appointment, stating, "Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development—from bench to bedside. His appointment to lead CDER brings exceptional scientific, regulatory, and operational expertise to the agency."

Leadership Changes and Agency Restructuring

Tidmarsh's appointment comes amid a period of significant turnover at the FDA. He replaces Jacqueline Corrigan-Curay, M.D., who has been serving as CDER's acting director since the departure of Patrizia Cavazzoni, M.D., earlier this year. This change follows other recent high-profile exits, including:

• Peter Marks, M.D., Ph.D., former director of the Center for Biologics Evaluation and Research (CBER)
• Nicole Verdun, M.D., and Rachael Anatol, Ph.D., from the cell and gene therapy office
• Hilary Marston, M.D., former FDA chief medical officer

The agency has also seen the appointment of Vinay Prasad, M.D., as the new head of CBER, signaling a potential shift in the FDA's approach to drug and biologics regulation.

Implications for FDA Policy and Drug Review Process

As Tidmarsh takes the helm at CDER, industry observers are watching closely for potential changes in the drug review and approval process. Tidmarsh has previously voiced support for removing "harmful, useless drugs from the market" and has been critical of scientific misconduct in academic research.

Commissioner Makary expressed his intention 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." This collaboration may lead to new approaches in drug evaluation and regulatory science.

The pharmaceutical industry will be keenly observing how Tidmarsh's extensive experience in drug development might influence CDER's policies and decision-making processes in the coming months.