Talk Bio

An unnamed pharmaceutical company filed a citizen petition on April 20, 2026, calling for the FDA to reform its policy of publicly releasing complete response letters (CRLs), deeming it unlawful and contrary to decades of practice. 2 3 The petition demands a clear process where FDA notifies manufacturers before releasing CRLs, allows 10 days to contest publication, and provides written reasoning if proceeding despite objections. 2 3 It raises intellectual property concerns, arguing that released CRLs contain competitively sensitive information that federal law requires protecting, and calls for sponsor input on redactions. 2 4 FDA began publishing over 200 redacted CRLs in July 2025 as part of its 'radical transparency' initiative, now expanded to more than 300, accessible on its website. 1 2 The policy has increased biopharma accountability by making companies more forthcoming about rejection details, though redactions and private meeting minutes limit full transparenc...