Executive Summary
In an unprecedented move, starting in July 2025, the U.S. Food and Drug Administration (FDA) released communications that have previously remained unpublished and confidential to the public. Specifically, Complete Response Letters (CRLs) were released in July 2025 for New Drug Applications (NDAs) or Biologics License Applications (BLAs) that were ultimately approved and granted by the FDA. On September 4, 2025, the FDA expanded the scope of released CRLs to include those associated with “pending” or “withdrawn” NDAs or BLAs, releasing an additional 89 CRLs. Going forward, the FDA announced that it will, in “real-time,” release newly issued CRLs and batches of previously issued CRLs associated with withdrawn or abandoned applications. This drastic change in FDA policy is intended to “embrac[e] radical transparency … and … restore[] public trust,” according to FDA Commissioner Dr. Marty Makary.1 This new level of transparency may have consequences for companies whose intellectual property (IP) protection strategies rely on nonpublication of CRLs.
Background
A CRL is a notification from the FDA to an applicant who has submitted an NDA or a BLA. The CRL indicates to the applicant that its NDA or BLA cannot be approved in its current form, and outlines the reasons for non-approval, including reasons related to safety, efficacy, and/or manufacturing. The CRL also outlines recommendations for the applicant to address deficiencies in the submitted NDA or BLA.
The FDA’s confidentiality regulation provides that “no data or information contained in the application or abbreviated application is available for public disclosure” until after an application is approved, or where the existence of an unapproved application or abbreviated application has been publicly disclosed or acknowledged.2 The regulation contains only a limited exception for summary information, such as that provided for an FDA advisory committee hearing. As such, CRLs have historically been communicated to the applicant only, remaining unpublished and confidential to the public.
In its September news release, the FDA states that “[p]ublishing CRLs offers important benefits for public health, including empowering drug developers to avoid common missteps and efficiently bring more cures and meaningful treatments to the American public; delivering greater insight to patients and the health care providers who treat them; and ensuring sponsors provide complete and contextualized information in communications to investors and shareholders.”
In this regard, the published CRLs included information such as company name, prescribing information, labeling, safety considerations, product quality, and recommendations for resubmission.3
The September news release further states that the publication of CRLs complies with President Trump’s Executive Order 14303, ordering all agencies to release “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.”4
Implications on the FDA’s Publication of CRLs
The FDA’s release of CRLs brings with it an increased risk of public disclosure of an applicant’s technology, which otherwise may have remained confidential. For example, in many instances, CRLs contain confidential and proprietary information relating to an applicant’s technology, including experimental details, technical assessments, developments in clinical trials, and particulars of an applicant’s product.
To avoid releasing confidential information in published CRLs, the FDA states that “[a]ll CRLs will be redacted to remove confidential commercial information, trade secrets, and personal private information, but will contain company names.” However, there still remains a risk of disclosure of IP as the criteria and methodology for redacting such information remains unclear and the standard of “confidential commercial information, trade secrets, and personal private information” has not been delineated. The FDA’s Disclosure Team is responsible for redacting CRLs in accordance with the agency’s updated policy guidelines, and each CRL is assessed and redacted independently.
What Should Applicants Do?
The FDA has announced a “real-time” release of CRLs but has not detailed the specific dates in which a CRL will be publicly disclosed. Because applicants may not have an opportunity to comment before their CRL is publicly disclosed, applicants that wish to avoid disclosure of their proprietary data in a CRL should label relevant portions of their submissions as “Trade Secret” or “Confidential Commercial Information” and may wish to seek a hearing or stay of publication in advance of the FDA goal date for their application.
Additionally, applicants should consider the FDA’s release of CRLs when evaluating and developing patent and trade secret strategy. For example, applicants may consider the following:
- File a provisional patent application at the U.S. Patent and Trademark Office (USPTO) relating to technology disclosed in submitted NDAs or BLAs prior to submission to the FDA.
- Cite a released CRL in an information disclosure statement (IDS) for relevant patent applications prosecuted at the USPTO.
- During prosecution of a patent application, refrain from contradicting statements and documentation submitted to other agencies (e.g., arguments in responses to office actions).
- Revisit company trade secrets and consider whether certain trade secret information should now be protected via a patent.
- Maintain pendency of core patent families by filing continuation applications to capture potential CRL-driven adjustments claim strategy.
- Align IP and regulatory strategies to form a strong narrative connecting public FDA-issues with patent filings.
- Monitor released CRLs for competitor insights.
In addition to considering the effects of CRL publications, companies are cautioned that the FDA’s “radical transparency” of publishing CRLs is just one example of President Trump’s Executive Order 14303 to all agencies and is a reminder to companies to stay vigilant in mitigating unintentional disclosure by developing a thoughtful IP strategy.
Publicly traded companies that are subject to SEC disclosure requirements should work closely with their regulatory and corporate counsel to evaluate the potential impact of CRL publication by the FDA on their SEC disclosure obligations, including potential risks associated with the sponsor’s competitive dynamics, as competitors will now have greater visibility into the sponsor’s setbacks, and risk of securities litigation following negative public disclosures.
Conclusion
The FDA’s recent release of 89 CRLs for pending and withdrawn applications, as well as its intention to continue to release CRLs in “real-time” moving forward, is a drastic change in the FDA’s longstanding policy to keep CRLs unpublished and confidential. Although the FDA has promised to redact confidential, trade secret, and private information, applicants should re-evaluate their IP strategy to protect themselves from potential risks of disclosure. Furthermore, applicants should stay abreast of changes in law and policy. In this regard, the FDA’s “radical transparency” posting of CRLs may be affected by future litigation as interested parties may assert arguments related to violation of confidentiality.
[1] https://www.fda.gov/news-events/press-announcements/fda-announces-real-time-release-complete-response-letters-posts-previously-unpublished-batch-89.
[2] 21 C.F.R. § 314.430(d)(1); 21 C.F.R. § 601.51.
[3] https://open.fda.gov/crltable/.
[4] https://www.federalregister.gov/documents/2025/05/29/2025-09802/restoring-gold-standard-science.
