An unnamed pharmaceutical company filed a citizen petition challenging the FDA’s practice of publicly releasing complete response letters (CRLs). The petition, dated April 20, argues the disclosure process is unlawful and seeks a structured mechanism for sponsors to respond before release. The company requests that FDA inform manufacturers before publishing CRLs and provide a 10-day window to contest publication. If the FDA proceeds despite an objection, the petition asks for written notification and an explanation of reasoning. The petition cites intellectual property concerns, characterizing CRLs as competitively sensitive nonpublic information that FDA should protect under federal law. The filing comes after FDA published more than 200 CRLs in July 2025 as part of a “radical transparency” push, and the set reportedly has grown beyond 300 letters. Analysts have previously described the disclosures as beneficial for accountability, but the petition signals that at least some sponsors view the policy as creating new disclosure risk even when the intent is transparency around regulatory review outcomes.
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