Richard Pazdur told reporters he was pressured to endorse the FDA’s decision to reduce clinical trial requirements for new drug approvals. Pazdur, the former head of the agency’s oncology unit, said he was handed a pre-written press release with a quotation attributed to him and told to "just agree to it." His account frames recent internal tensions at the FDA over Commissioner-led policy changes that lower evidentiary standards for approval. Pazdur’s remarks name-check the procedural dynamics that preceded his exit and provide a rare, direct window into disputes between career regulators and political leadership. Pazdur’s statements were given to The Wall Street Journal and highlight friction inside CDER and the Oncology Center of Excellence. For industry stakeholders, the episode signals potential shifts in review norms and highlights reputational and operational risks for sponsors navigating evolving FDA expectations.
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