FDA’s push to publish complete response letters faces legal uncertainty and possible pause

The FDA began releasing complete response letters (CRLs) to the public last year, a move promoted as increasing transparency for drug developers, investors, and patients.

However, the policy has encountered legal challenges because regulations consider the existence of an application confidential, and some experts say publishing certain CRLs may not be permissible.

Former commissioner Marty Makary, who announced the initiative in 2025, is no longer at the agency, and recent statements from the FDA have alternated between pausing, resuming, and reaffirming commitment, reflecting an unsettled situation.

Legal analysts at law firms note that the lack of clear authority could force the FDA to limit or stop the practice, leaving the industry uncertain about the future of CRL transparency.