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.23
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.23
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.24
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.12
The policy has increased biopharma accountability by making companies more forthcoming about rejection details, though redactions and private meeting minutes limit full transparency.1
Sources:
1. https://www.biospace.com/fda/fdas-crl-transparency-policy-is-boosting-biopharma-accountability
2. https://www.biospace.com/policy/unnamed-pharma-files-citizen-petition-targeting-fdas-trove-of-rejection-letters
3. https://www.fiercepharma.com/pharma/citizen-petition-behalf-unnamed-pharma-calls-fda-tighten-its-crl-disclosure-practices
4. https://www.wsgr.com/en/insights/fdas-release-of-complete-response-letters-raises-questions-related-to-intellectual-property.html