Recent events at the U.S. Food and Drug Administration (FDA) have brought attention to internal operational challenges and questions over regulatory decision-making processes. In a town hall meeting, FDA leader George Tidmarsh acknowledged staffing concerns and emphasized efforts to normalize operations amid a challenging period. Concurrently, criticism has mounted over the FDA convening informal expert panels that bypass standard advisory committee procedures, raising issues of transparency and conflicts of interest. Notably, these procedural shifts have sparked debate regarding the rejection of innovative therapies such as Replimune’s RP1 for advanced melanoma despite internal expert support. This confluence of staffing and procedural controversies points to deeper institutional tensions with implications for drug approval trustworthiness and innovation pathways.