Richard Pazdur, who left the FDA’s top drug review role, told The Wall Street Journal he was asked to endorse agency messaging on reducing clinical‑trial requirements, saying he was handed a press release with his quote and asked to "just agree to it." Pazdur criticized recent policy shifts that allow single‑trial approvals and signaled concerns about political pressure and diminished review autonomy. The remarks add to internal controversy at FDA under Commissioner Marty Makary, with contrasting statements from HHS defending the reforms as urgent and in patients’ interests. The episode amplifies debate over regulatory standards, reviewer independence, and the evidentiary bar for approvals, particularly for oncology and other high‑risk areas. Biotech companies and investors will watch how the agency balances speed with rigorous evidence standards; changes in review dynamics could reshape program design, approval probability, and post‑market obligations for sponsors.
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