Rules Needed on Complete Response Letter Transparency: Researchers
Clear rules are needed for when FDA decides to publicly release complete response letters (CRL), according to a new analysis published in the Journal of Law and the Biosciences. The CRL postings, which were launched under former FDA commissioner Marty Makary as part of a broader “radical transparency” effort, are intended to provide drug developers, investors and the public with greater insight into FDA decisions.
The agency has argued that broader disclosure would help companies better understand regulatory expectations and avoid repeating development mistakes. The move represented a significant departure from longstanding FDA practice. Historically, CRLs generally have not been publicly disclosed when they involve unapproved products because they may contain confidential commercial information, including details from pending applications.
The transparency initiative quickly drew criticism from industry attorneys and regulatory experts, who questioned whether FDA had sufficient legal authority to release the letters before products were approved and whether sponsors should have an opportunity to review and redact confidential information before publication. An April citizen petition from Covington & Burling that was submitted on behalf of an unnamed pharmaceutical company challenged the agency's authority and implementation of the transparency initiative.
FDA is also moving ahead with plans to formalize the policy through notice-and-comment rulemaking. An agency-planned rulemaking listed in the recent unified agenda as “Proactive Disclosure of Complete Response Letters” would amend FDA regulations governing the confidentiality and disclosure of regulatory correspondence and establish a formal framework for releasing redacted CRLs. It is scheduled for publication as a proposed rule in October.
The new study examines FDA’s shift toward greater CRL disclosures, with researchers cautioning that the new transparency system remains unsettled. The agency has promised to release new CRLs “promptly,” but has not established a specific deadline, they note. The researchers recommend a defined publication timeline, consistent standards for redacting confidential commercial information and structured data that would make the letters easier to search and analyze.
They also propose that the FDA provide a short, neutral explanation when extensive redactions or highly technical language make a CRL difficult to understand. Such summaries would not replace the original letters but could give patients, clinicians and other non-specialists a clearer picture of why a drug was not approved.
The study points to the European Medicines Agency as a potential model. Unlike FDA’s historically confidential approach, the EMA routinely publishes assessment reports for approved and refused medicines and provides public information in some cases involving withdrawn applications. The authors say the European system demonstrates that greater transparency can coexist with protections for legitimate trade secrets and confidential commercial information.
The researchers emphasize, however, that FDA CRLs and EMA assessment reports serve different purposes. FDA letters can provide granular, agency-authenticated details about specific deficiencies, while EMA reports generally offer a more structured explanation of the agency’s overall assessment and benefit-risk determination.
The authors ultimately argue that transparency should become a permanent part of FDA’s drug-review process rather than an occasional disclosure initiative. They recommend that the agency routinely publish prior CRLs when a drug is eventually approved and provide standardized information about each review cycle, including the deficiencies identified and how they were resolved.
Such changes, they conclude, could turn unsuccessful drug applications into a source of regulatory and scientific learning while still protecting genuinely confidential business information.
“Transparency and confidentiality can coexist with smart policy design,” the authors argue, contending that greater visibility into regulatory failures could benefit patients, scientists, drug developers and regulators alike.