Industry surveys and op‑eds documented growing unease over regulatory stability and leadership at the U.S. Food and Drug Administration. BioCentury’s survey captured broad investor and developer concern about politicization, volatility and unpredictability in approvals and policy. Separately, regulatory commentators argued recent high‑level memos and unilateral actions show a breakdown in customary administrative processes, citing internal memos and public statements. Biopharma executives say the uncertainty raises development risk and could slow investments; patient groups and policy experts urged transparent processes and clearer guidance. Companies are recalibrating regulatory strategies and contingency plans while dialogues with the agency continue.