The FDA’s policy of publishing complete response letters (CRLs) for rejections has encountered legal uncertainty, according to experts and session discussions tied to the BIO International Convention 2026. Lawyers said the agency’s approach may conflict with FDA rules treating certain application information as confidential. Former FDA officials previously cited legal concerns, including whether publishing a CRL for an application that was not publicly disclosed could violate the agency’s own regulations. Elizabeth Jungman, partner at Hogan Lovells, said that during her time at the FDA the agency opted against publishing CRLs because “Publishing certain CRLs is just not legal.” Other experts flagged potential litigation risk, with Peter Dickos and Hyman, Phelps & McNamara warning in a September blog post that “litigation may follow.” Covington & Burling also raised concerns in a citizen petition filed on behalf of an unnamed drugmaker. The FDA has moved to solidify the legal basis by considering FDCA amendments and proposed rules on CRL release, but the policy’s footing remains contested as industry seeks clearer boundaries around transparency and confidentiality.