FDA's Transparency Policy Faces Legal Challenges Amid CRL Publication Controversy
The FDA's decision to publish complete response letters (CRLs) has sparked legal uncertainty and debate. Initially introduced by former Commissioner Marty Makary in 2025, the policy aimed to enhance transparency for drug developers, investors, and patients. However, the legal foundation of this initiative is now under scrutiny. Concerns have been raised about the legality of disclosing CRLs, as the FDA's regulations consider the existence of an application confidential. Legal experts, including Elizabeth Jungman and Peter Dickos, have highlighted potential litigation risks and the need for regulatory amendments. The FDA is considering changes to the Federal Food, Drug, and Cosmetic Act to solidify the policy's legal basis. Despite the pause and resumption of CRL publications, the agency has yet to clarify its approach, leaving stakeholders uncertain about the policy's future. 
