Key Takeaways
- George Tidmarsh appointed to lead Center for Drug Evaluation and Research (CDER): The seasoned biotech and clinical expert brings over 30 years of experience to the FDA’s top drug oversight role.
- Focus on scientific rigor and reform: Tidmarsh is expected to restore internal review standards following criticism of past leadership’s controversial drug approvals.
- Regulatory priorities include mifepristone and legacy drugs: The FDA under Tidmarsh will reassess safety of abortion pill and reexamine antidepressant and hormone therapies.
The FDA announced that it has appointed George Tidmarsh, MD, PhD, as the new dDirector of the Center for Drug Evaluation and Research (CDER)., placing a seasoned physician-scientist at the helm of one of the agency’s most critical divisions. According to the federal agency, Tidmarsh will work to lead the FDA’s efforts to ensure safe, effective, and high-quality drugs are available to people in the United States, bringing over three decades of experience in biotechnology, clinical medicine, and regulatory science.1
What does George Tidmarsh’s Appointment Signal for the Future of FDA Drug Oversight?
“Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development—from bench to bedside,” said Marty Makary, MD., MPH, FDA Commissioner, in a press release. “His appointment to lead CDER brings exceptional scientific, regulatory, and operational expertise to the agency.”
A Background in Translational Research and Drug Development
Prior to joining the FDA, theTidmarsh—a Stanford-trained pediatric oncologist and neonatologist—co-founded Stanford’s Master of Translational Research and Applied Medicine (M-TRAM) program, which trains researchers to bridge the gap between scientific discovery and clinical application. He has authored 143 scientific publications and patents, led the clinical development of seven FDA-approved drugs, and served as CEO or founder of multiple biopharmaceutical companies focused on oncology and critical care medicine.1
Transition in Leadership at CDER
The announcement follows the retirement of Jacqueline Corrigan-Curay, former acting director of CDER.
Regulatory Priorities Under Tidmarsh
As the FDA’s lead official for drug oversight, Tidmarsh will be tasked with advancing key priorities set by Commissioner Makary and Health Secretary Robert F. Kennedy Jr.—including reassessing the safety profile of the abortion medication mifepristone. The agency is also reexamining specific uses of longstanding therapies such as antidepressants and hormone treatments used in menopause.2
Criticism of Former CDBER Leadership
In April, Tidmarsh published an opinion piece in RealClear Policy criticizing the leadership of Peter Marks, the former director of the FDA’s Center for Biologics Evaluation and Research. In it, he cited concerns over what he viewed as a pattern of bypassing internal expert review, advisory committees, and long-standing regulatory norms. While he acknowledged the urgency of medical innovation, Tidmarsh argued that scientific rigor and internal consensus must remain central to the FDA’s mission—especially during public health emergencies and in the evaluation of high-cost, high-risk therapies.3
In April, Tidmarsh penned an opinion piece for RealClear Policy, in which he criticized Peter Marks, former director of the FDA’s Center for Biologics Evaluation and Research, on a number of decisions made during his tenure. This included what Tidmarsh called repeatedly sidelining FDA career scientists and bypassing advisory committees in advancing controversial approvals, including the initial authorization of COVID-19 vaccines, the greenlighting of the Alzheimer’s drug Aduhelm, and most recently, the approval and subsequent expansion of Elevidys in Duchenne muscular dystrophy. Tidmarsh pointed out that Elevudys was granted FDA approval despite failed efficacy endpoints and a known toxicity profile—including liver failure in 22% of patients—culminating in a patient death in July 2024.
Tidmarsh also noted that FDA staff, as well as advisory experts, raised concerns across all three high-profile cases, warning of insufficient safety and efficacy data, with Marks reportedly overruling them on all counts, with Tidmarsh stating led to public outcry, resignations, and, in the case of Aduhelm, a formal congressional investigation.
Broader Workforce Changes Across the Agency
Since February, around 2,000 individuals have been laid off from the FDA under a federal directive to cut probationary employees across agencies, with over 1,000 more taking early retirement or buyouts. Several former officials from agencies such as the CDC and NIH have publicly opposed the cuts.2,4
“I look forward to working with Tidmarsh to strengthen our drug review programs, foster innovation, and advance cross-agency initiatives that improve health outcomes for the American public,” concluded Makary, in the press release.
References
- Stanford faculty member George Tidmarsh, M.D., Ph.D. named Director of Center for Drug Evaluation and Research. FDA. July 21, 2025. Accessed July 23, 2025. https://www.fda.gov/news-events/press-announcements/stanford-faculty-member-george-tidmarsh-md-phd-named-director-center-drug-evaluation-and-research
- FDA names former pharmaceutical company executive to oversee US drug program. Associated Press. July 21, 2025. Accessed July 23, 2025. https://apnews.com/article/fda-drugs-trump-makary-george-tidmarsh-88471eab7dcaf1ab8cc4dd2491218120
- Why Peter Marks Was Asked to Leave the FDA. RealClear Policy. April 1, 2025. Accessed July 23, 2025. https://www.realclearpolicy.com/2025/04/01/why_peter_marks_was_asked_to_leave_the_fda_1101330.html
- Former Health Agency Heads React to Federal Layoffs at NIH, CDC, and FDA. PharmExec. February 19, 2025. Accessed July 23, 2025. https://www.pharmexec.com/view/former-health-agency-heads-federal-layoffs-nih-cdc-fda
