Dr. George Tidmarsh, a physician, academic, and biotech entrepreneur, has been appointed as the new director of the FDA’s Center for Drug Evaluation and Research (CDER). This role is crucial as it oversees the review of new drugs and ensures their safety and effectiveness. While Tidmarsh has not worked in government before, his connections to the FDA’s leadership and his background in medicine and biotech helped secure this position. The job is complex, requiring him to balance drug reviews, set policies, and work with international regulators. Aman Khera, president of TOPRA, describes the role as part scientist, part CEO, and part diplomat. The FDA is currently facing challenges, including staffing cuts and efforts to modernize its review process using AI. There’s pressure to keep reviews fast and safe despite limited resources. Tidmarsh replaces Dr. Jennifer Corrigan-Curay, who took over after Dr. Patrizia Cavazzoni left before President Trump took office. Tidmarsh’s biotech background has raised concerns about conflicts of interest between the FDA and drug companies, but experts say physician-scientists or industry leaders are often chosen for this role. Pharma companies want clear and consistent review processes so they can plan their drug development with confidence. They also seek guidance on new treatments and regulatory approaches. Tidmarsh has ties to Stanford University, where he studied cancer biology and now teaches. He has also been involved in controversial medical journals and has criticized the government’s handling of COVID-19, including suggesting the virus may have originated in a lab. He has also criticized past FDA decisions on COVID vaccines, Alzheimer’s treatments, and gene therapies. Despite his experience, Tidmarsh admits he needs to improve his leadership skills, especially in motivating large teams. He praises the FDA’s work but believes there’s room for improvement, particularly in making reviews more efficient and consistent. The FDA is also working to integrate AI and real-world data into its decision-making, which could lead to inconsistencies. Tidmarsh has called for removing politics from public health decisions to restore trust in health agencies.