The FDA’s push for greater transparency around complete response letters (CRLs) is facing mounting legal uncertainty, with experts warning the initiative may conflict with rules on the confidentiality of application existence. The policy began with the FDA publishing full CRLs without consulting the public, but attorneys say the legal foundation has shifted through pauses, resumption, and proposed rulemaking. Hogan Lovells partner Elizabeth Jungman, speaking at BIO International Convention 2026, said FDA counsel previously found publishing certain CRLs “just not legal” under existing regulations. She also highlighted how the release of CRLs for submissions not publicly disclosed could breach agency rules that treat application existence as confidential. Additional legal concerns were raised in a September warning from Hyman, Phelps & McNamara and in a citizen petition filed by Covington & Burling on behalf of an unnamed drugmaker. The FDA later moved toward solidifying the approach by proposing amendments to the FDCA and issuing a rule proposal for CRL releases.