On September 4, 2025, the U.S. Food and Drug Administration (“FDA”) announced plans to begin releasing complete response letters (“CRLs”) “promptly” after it issues them to sponsors, rather than waiting until after approval. Additionally, FDA released a batch of 89 CRLs for currently pending or withdrawn drug and biologic applications. The publication of CRLs relating to unapproved applications marks a significant departure from past FDA disclosure policy and raises potentially thorny legal questions. This client alert briefly describes FDA’s latest actions, the legal and policy issues they raise, and what to expect next.
FDA’s Announcement
FDA’s September 4 announcement appears to mean that, effective immediately, FDA will begin releasing any future CRLs promptly after issuing them to new drug application (“NDA”) or biologics license application (“BLA”) sponsors. FDA also announced that it will release all CRLs associated with an NDA or BLA at the time of approval and that it will publish additional batches of previously issued CRLs associated with withdrawn and abandoned NDAs and BLAs. FDA’s disclosure of this latest batch of CRLs follows its July press release and announcement of future plans to publish CRLs in “real time,”1 which was accompanied by the release of more than 200 CRLs related to approved drug and biologic marketing applications (discussed in a previous Ropes & Gray Alert). Unlike the CRLs released in July, the latest batch involves categories of CRLs that FDA has never previously made available to the public.
FDA’s latest announcement emphasizes that its actions mark a “significant step in the agency’s broader initiatives to modernize and increase transparency” and aligns with President Trump’s May 2025 executive order titled “Restoring Gold Standard Science.” That executive order directs agencies to make publicly available “data, analyses, and conclusions associated with scientific and technological information produced or used by the agency that the agency reasonably assesses will have a clear and substantial effect on important public policies or important private sector decisions.”
Newly Released CRLs
FDA notes that, while the CRLs disclose the identity of the sponsor recipient, they are otherwise redacted for confidential commercial information, trade secrets, and personal private information under the Trade Secrets Act (18 U.S.C. 1905) and the Federal Food, Drug, and Cosmetic Act (“FDCA”) (21 U.S.C. 331(j)). The current batch of CRLs for unapproved or withdrawn applications reveals significant redactions by FDA for nonclinical, product quality, and product labeling information. In some letters, entire sections are redacted. CRLs related to problematic facility inspections redact the name of the relevant facility. The name and contact information for the FDA employee who signed the CRL have been redacted as well. However, sections of CRLs discussing clinical trial-related deficiencies, such as the failure to meet safety or efficacy endpoints, and FDA’s recommendations for addressing those failures, have generally been left unredacted. It is FDA’s public disclosure of those scientific details for currently pending NDAs or BLAs that is likely to be the most controversial aspect of FDA’s newly announced CRL policy.
Both the initial batch of CRLs that FDA released in July and the newly released batch are currently available to the public on FDA’s website, openFDA. When FDA first announced in July that it would begin to publish CRLs, only a downloadable file containing the initial batch was available. In addition to being able to download released CRLs, openFDA now includes a function that allows users to search CRLs by company name and directly download CRLs for unapproved or approved applications, making it easier to identify and access all CRLs issued to a particular company.
Policy Rationale
When FDA announced its plan to release CRLs in July, it emphasized its goal of reducing the drug development timeline by providing sponsors with insight into FDA decision-making and ensuring that pertinent information about companies’ marketing applications is available to investors and shareholders. Due to the agency’s release at that time of previously published CRLs only for approved applications, it was unclear how far the agency would go in its embrace of “radical transparency,” especially considering legal requirements to protect confidential information. The September release shows that FDA intends to reveal a great deal of information about the reasons that drug applications failed to receive FDA approval, necessitated additional clinical or nonclinical research or product development work before they could be approved, or were abandoned by their sponsors. Though still heavily redacted, the released letters may help other manufacturers and researchers understand what types of clinical data or other problems can defeat, or at least delay, an application. Sponsors of applications that are the subject of released CRLs, however, may feel that FDA’s publication of clinical and other details about their products constitutes an infringement of their trade secrets and confidential commercial information, handing an unfair advantage to competitors and skewing market incentives for life sciences investments.
Unanswered Questions
Implementing these actions without seeking prior public input appears consistent with several other actions FDA, and its parent agency, the U.S. Department of Health and Human Services, have taken recently without following typical agency deliberative practices. In our previous alert, we questioned whether FDA can, under its existing regulations, legally publish CRLs for pending or withdrawn applications. By following the truncated and unofficial process it did, FDA left key legal questions unaddressed.
The openFDA webpage states that FDA derives its authority for releasing CRLs from the Freedom of Information Act at 5 U.S.C. 552(a), the FDCA at 21 U.S.C. 355(l), and FDA regulations at 21 CFR Part 20 and 21 CFR 312.130, 314.430, and 601.51. But the agency has not explained how it can release CRLs in real time without violating certain of these regulations.
Under the existing regulations, FDA is not permitted to disclose the existence of pending NDAs or BLAs unless the existence of those applications has already been publicly disclosed or acknowledged (see previous Ropes & Gray Alert for further analysis of FDA’s authority under its current regulations). For NDAs or BLAs that have been publicly acknowledged, the regulations provide that the FDA Commissioner may release a “summary of selected portions of the safety and effectiveness data” if appropriate for “public consideration of a specific pending issue.”2 At this stage, it is unclear whether FDA performed an application-by-application review and chose to release CRLs only for applications that had previously been disclosed or acknowledged. Even assuming FDA did so, however, it is unclear how FDA’s release of partially redacted CRLs constitutes a “summary of selected portions of the safety and effectiveness data” or how releasing such CRLs responds to a “pending issue” for “public consideration.” It is also unclear whether sponsors will be afforded an opportunity to review and comment on FDA’s proposed redactions prior to publication of a CRL. These aspects of FDA’s new policy could provide grounds for legal challenge, but whether any individual sponsor, group of sponsors (such as a trade organization), or other person will challenge FDA’s new policy remains to be seen. At least one sponsor has already issued a press release responding to FDA’s publication of its CRL, asserting that it did not receive prior notice that FDA would be posting its CRL and committing to make its preliminary response to the CRL available on the company’s website.3
Conclusion
The September release of CRLs related to pending or withdrawn NDAs and BLAs makes good on FDA’s promise to publish CRLs for unapproved products. Having shown its willingness to take this major step despite the prospect for legal challenge, FDA also can be expected to follow through on its promise to begin “real time” publication of CRLs. Whether this action will be the subject of legal challenge, or instead will become an accepted practice despite the legal and policy questions it raises, is unknown at this time.
