Industry Vet and Academic Tidmarsh Named CDER Head
FDA has named Stanford pediatrics (neonatology) adjunct professor George Tidmarsh, an industry veteran for over 30 years, as the new CDER director. Tidmarsh is replacing former Center director Patrizia Cavazzoni, who left the agency in the early days of the Trump administration and has since returned to her industry roots and rejoined Pfizer as the company’s chief medical officer (see earlier story).
“Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development—from bench to bedside,” FDA commissioner Marty Makary is quoted in a release as saying. “His appointment to lead CDER brings exceptional scientific, regulatory, and operational expertise to the agency.” Tidmarsh holds both medical and PhD degrees from Stanford, where he specialized in cancer biology and completed residency and fellowship training in pediatrics, pediatric oncology, and neonatology, he noted.
Tidmarsh has over 30 years of experience in the biotechnology industry, including the clinical development of six FDA-approved drugs, according to his bio. He previously served as the founder and chief executive officer of Horizon Pharma, where he led the development of Duexis, which was approved for treating rheumatoid arthritis. In 2022, Horizon was sold to Amgen for $28B, his bio says. He also founded Threshold Pharmaceuticals, Inc. and held senior positions at Coulter Pharmaceutical, Inc. (acquired by GlaxoSmithKline) and SEQUUS Pharmaceuticals, Inc. (acquired by Johnson & Johnson). While at Coulter and SEQUUS, Dr. Tidmarsh led the clinical development of BEXXAR and Doxil, two FDA-approved anti-cancer agents.
During his roles in academia., he co-founded and co-directed Stanford’s Master of Translational Research and Applied Medicine program, which focuses on training researchers to convert scientific discoveries into real-world therapies, Makary says. “I look forward to working with him to strengthen our drug review programs, foster innovation, and advance cross-agency initiatives that improve health outcomes for the American public.”
Tidmarsh’s appointment “brings in a generally well-respected, credible industry veteran, we believe helping fill a key regulatory void,” according to an investor note from RBC Capital Markets analyst Brian Abrahams and reported by Bloomberg News. While recent cuts at the agency have raised concerns about FDA’s drug approval process, “we would expect Tidmarsh to be a pragmatic officer who will likely build upon current practice to ensure continuity and potentially be an advocate for the industry,” he writes.
Tidmarsh’s leadership could also advance the agency’s reassessment of its approach to regulating prescription drug advertising. HHS secretary Robert F. Kennedy Jr. has recently criticized direct-to-consumer drug advertising, and Makary has indicated that the agency will look at its approach to regulating such ads, Bloomberg notes.
During a Stanford panel on censorship and scientific speech last year, Tidmarsh raised concerns about the agency’s inconsistent regulation of off-label communications by regulated industry and questioned some vaccine makers’ ads during the pandemic.
Meanwhile, former Alliance for a Stronger FDA executive director and now-FDA policy and regulatory expert and author of the blog, FDA Matters (www.fdamatters.com) Steven Grossman had this to say about the appointment: “What is most notable about Dr. Tidmarsh is how much he is like commissioner Makary and Dr. Prasad, the new head of CBER. That is, they are all intellectually elite, extremely articulate, deeply tied to academic medicine, and steeped in drug science and questions of epistemology. Additionally, they are all outspoken, critical of the so-called scientific establishment, and relish the role of iconoclast. CDER is much larger than CBER and requires more management experience — something Dr. Tidmarsh provides as well.”