CRLs Today, (Potential) Lawsuits Tomorrow

FDA’s recent release of 89 Complete Response Letters (“CRLs”) for pending or withdrawn applications (which we blogged about here), and its promise to continue to do so in “real-time” going forward (here), has marked a significant change in FDA policy.  Before that, the agency generally took the view that such CRLs were not disclosable under the Freedom of Information Act (“FOIA”) and FDA’s regulations.  Now, FDA is releasing these letters, redacted for what it has asserted is confidential commercial information (“CCI”), trade secrets, and personal private information.  What FDA treats as confidential/non-disclosable information is generally covered in 21 C.F.R. § 20.61, with an array of statutes applying as well.

But another regulation looms larger here: 21 C.F.R. § 314.430, going back to 1985, which provides that FDA will not disclose even “the existence of” an NDA or ANDA before an approval letter or tentative approval letter is sent to the applicant unless the existence of the application “has been previously publicly disclosed or acknowledged.” And where it has not been, “no data or information” in the application can be disclosed to the public. Id. § 314.30(c).  Even when such a pending application’s existence has been disclosed or acknowledged, no data or information in the application can be disclosed before the agency sends an approval letter, with exceptions for the Commissioner, in his or her discretion, to “disclose a summary of selected portions of the safety and effectiveness data that are appropriate for public consideration of a specific pending issue; for example, for consideration of an open session of an FDA advisory committee.”  Id. § 314.430(d)(1). And only after FDA sends an approval letter to the applicant will certain data and information be disclosed.  Id. § 314.430(e), (f).  21 C.F.R. § 601.51 provides essentially the same disclosure limitations for BLAs.

FDA has relied on this approved/unapproved distinction to disclose redacted CRLs after it has approved an application.  This includes releasing them as part of the action packages available on FDA’s Drugs@FDA website, and indeed, FDA has a statutory obligation to disclose the action packages for certain approved original marketing applications.  FDA’s disparate treatment of approved and unapproved applications is why FDA’s July 2025 announcement of its release of CRLs for approved applications didn’t make huge waves.  No more.

Some will certainly applaud the increased transparency in this policy change, which will provide a window on FDA’s thinking when reviewing applications, and possibly help applicants read the tea leaves to design their development programs to have a better, faster shot at FDA approval.  Indeed, there was much discussion of ideas like this back in 2010, when FDA created a Transparency Task Force that drafted proposed reforms on disclosure of things like CRLs and invited public comment.  See FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. FDA (May 2010).  But other stakeholders are likely to be far less enthusiastic, particularly since FDA announced this change and posted the letters without a Federal Register Notice, creating a docket to solicit public comment on this new initiative, or the like.

In addition, the publication of this recent batch of CRLs (and the promise to post additional CRLs in “real-time” going forward) introduces risks that drug developers cannot ignore.  While manufacturing deficiencies are routinely redacted as CCI in both the pre-approval and post-approval setting, clinical and statistical deficiencies are largely unredacted in these CRLs despite the fact that, in the pre-approval context, many sponsors may regard this information as equally sensitive.  Sponsors invest significant resources into designing pivotal trials, selecting endpoints and developing statistical methodologies — decisions that reflect years of strategy and regulatory engagement.  In a competitive space, details of a pivotal trial’s primary endpoint or the statistical methods applied could have real commercial value.  A publicized CRL might disclose such details for the first time, effectively serving as an announcement of key aspects of a development program. Disclosure of FDA’s clinical or statistical critiques can provide competitors with a roadmap to avoid similar pitfalls, accelerate their own development programs, or strategically differentiate their trials.  Moreover, unlike the information that might be presented at an Advisory Committee which generally reflects the perspectives of both FDA and the applicant, a CRL is one-sided and likely will not present the applicant’s perspective or interpretation.

There is also the prospect that FDA’s own behavior might shift in response to this policy. If CRL signatories know the identified deficiencies will immediately become part of the public record, will they alter the tone, phrasing, or even substance of CRLs?  Sponsors have a vested interest in ensuring that regulatory communications remain candid, precise, and consistent, and we hope that the move toward greater transparency does not inadvertently lead to less informative feedback.

Interestingly, the agency redacted the names of the signatory for each of the 89 CRLs it recently posted, citing a (b)(4) exemption which, under FOIA, is an exemption that only applies to trade secrets and CCI.  Yet, these authors fail to see a plausible (b)(4) basis for this redaction since the identity of an FDA decision-maker is not proprietary to the applicant (maybe FDA meant to say (b)(6)?).  Historically, FDA has not ordinarily redacted out these names when it released CRLs post-approval, including in its July 2025 batch.

Like others following this shift in policy, we anticipate litigation may follow from those whose information is released or may about to be released as part of a CRL for a pending or withdrawn application, particularly where they consider it to contain their CCI/trade secret information that was not properly redacted.  And whether the agency complied with its own regulations, including 21 C.F.R. §§ 314.430 and 601.51, in doing so may well be a big part of any such litigation.  Opposing those applicants’ interests are likely to be an agency and other outsiders advocating for the salutary benefits of sunlight.  In that vein, it will be interesting to see if this new policy prompts an influx of FOIA requests and challenges from outside parties seeking more information based on what they’ve newly gleaned about the pending and withdrawn applications, whether those requests are for what lies behind the redactions in the CRL, or for other documents like the intra-agency reviews supporting the decision, which FDA also has not generally released before approval.  But see Vanda Pharms., Inc. v. FDA, No. 22-CV-938 (CRC), 2023 WL 2645714 (D.D.C. Mar. 27, 2023) (holding FDA had not justified withholding from an applicant review documents under the deliberative process privilege after a CRL had issued).

And on the less confrontational side, other fallout from this policy change could come in the form of applicants reshaping their shareholder disclosure practices, as applicants will need to take care to ensure their public filings and shareholder communications are consistent with what becomes part of the public record.  Furthermore, applicants will likely attempt to even more clearly designate what they consider to be their CCI and trade secrets, not only in their applications but in all communications with the agency going forward, and an agency now having a much broader and real-time audience to consider when drafting CRLs.

Whatever comes next, we have the feeling we are only at the beginning of the story.