A FDA policy to increase transparency around complete response letters (CRLs) is running into legal uncertainty, according to reporting that points to evolving agency actions and concerns that the initiative may conflict with existing confidentiality rules. Former FDA Commissioner Marty Makary had praised publishing complete CRLs as a win for developers, investors, and patients when he unveiled the approach in 2025. However, lawyers and experts cited in the report raise questions about whether CRL releases could breach regulations that treat the existence of an application as confidential, especially for submissions not publicly disclosed. The report describes a cycle of pause, resumption, and ongoing commitment as the FDA considered solidifying the legal foundations. The FDA has also been described as looking to amend the FDCA and issue rules to publish CRL releases, reflecting the regulatory friction between transparency goals and disclosure constraints. Additional concerns include potential litigation risk if CRL publishing expands beyond a narrow, legally supported scope. For biotech companies planning development communications and investor updates, the situation directly affects how rejection information may be disclosed and how quickly disclosures may be challenged.