Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

In a move FDA is calling “radical transparency,” the Agency announced on July 10, 2025 that it has published 200+ Complete Response Letters (CRLs) issued in response to marketing applications for drugs and biologics on its openFDA database.  These particular CRLs were issued in response to original and supplemental drug and biological product applications submitted to the Agency between 2020 and 2024 that ultimately gained approval. However, the vast majority of the CRLs posted in the openFDA database are already available in the action packages posted on FDA’s Drugs@FDA database and approved biologics product pages. While the announcement states that FDA is planning to publish additional CRLs from its archives, it is not clear if those CRLs will also be for approved products for which the action packages are already available or products that have not been approved.

Commissioner Makary linked this initiative to his broader effort to enhance public trust through transparency, stating “[d]rug developers and capital markets alike want predictability. Greater transparency into our decisions will help align expectations and foster better communication among stakeholders.” The announcement goes on to say that, due to the historical practice of “refrain[ing] from publishing CRLs for pending applications, sponsors often misrepresent the rationale behind FDA’s decision to their stakeholders and the public” (emphasis added). The announcement references a 2015 analysis conducted by FDA of 61 CRLs issued between 2008 and 2013 (48 for New Drug Application [NDAs] and 13 for Biologics License Application [BLAs]) attempting to compare the reasons identified in those CRLs for not approving a product with the respective applicants’ public statements regarding the CRL (which we blogged about here; the FDA’s full analysis is available here). This latest initiative suggests FDA’s concerns regarding sponsors’ disclosure of the substance of CRLs persists.    However, it is difficult to see how releasing CRLs to the openFDA database that are already available as part of a product’s action package at Drugs@FDA mitigates these concerns.

Taking a step back, a CRL is a letter sent to an applicant at the end of FDA’s review cycle of an NDA or BLA when the Agency concludes that the application cannot be approved in its current form. The CRL outlines the specific deficiencies preventing approval or licensure, which often relate to safety or efficacy concerns, problems with manufacturing processes, or, in the case of generics, failures to demonstrate bioequivalence. The letter provides detailed descriptions of the deficiency(ies) and often includes FDA’s suggestions or requirements for resolving them. After receiving a CRL, the applicant must decide whether to address the deficiencies noted in the CRL or, if addressing the deficiencies are too burdensome, withdraw the application entirely. If a drug is approved, section 916 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (codified at 21 U.S.C. § 355(l)) requires that action packages (which include CRLs, if issued) for approved original NDAs and BLAs (i.e., where no active moiety for a drug or no active ingredient for a biological product has been approved in any other application) be posted online within 30 calendar days of approval or within 30 days of the third Freedom of Information Act (FOIA) request for that package.

FOIA is a federal law that gives the public the right to request access to records from any federal agency, including FDA. The goal of FOIA is to promote transparency and accountability in government by allowing the public to obtain information about agency operations, decisions and communications. However, FOIA has exemptions, which are categories of information that agencies are allowed or are required to withhold. Relevant here, FOIA Exemption 4 protects trade secrets and confidential commercial information. As such, any information in an approval package, including a CRL, must be redacted prior to public disclosure to protect this information and these redactions may be substantial, particularly in cases involving manufacturing processes, formulation details, or future development plans.

Commissioner Makary’s announcement, made the same day as his statement touting his accomplishments in his first 100 days leading FDA, raises questions about whether this effort is truly “radical transparency” or just a repackaging of existing requirements. The key difference may lie in timing and ease of access; despite the statutory requirement under FDAAA, action packages are often slow to appear on FDA’s website, especially following staffing disruptions at FDA. For example, the FDA staff responsible for posting action packages and responding to FOIA requests were subject to the FDA’s Reduction in Force earlier this year (which we blogged about here). This disruption led to a backlog in public postings of approval materials and responses to FOIA requests. Even as some FOIA staff have returned to the Agency, a backlog continues to persist and some approval packages have yet to appear on FDA’s website.

It is currently unclear whether FDA intends to publish CRLs close in time to their issuance or for applications that are not subsequently approved. (Query how FDA would make this determination and when – only after a sponsor withdraws their application?) The prospect of publication of such CRLs would likely be of great concern to many applicants and of great interest to their competitors. Regardless, we will be watching to see how this radical transparency initiative unfolds.