CRL Release Update – No litigation war yet, but new Citizen Petition beats the drums

Last September, we blogged about FDA’s release of Complete Response Letters (“CRLs”) for unapproved NDAs and BLAs, which since then have continued at a steady clip.  We observed that the policy marked a significant change from FDA’s longstanding position that such CRLs were exempt from disclosure under FOIA and FDA’s own regulations, that this shift in policy was accomplished without undertaking expected administrative processes, such as a Federal Register Notice or a docket to solicit public comment, and that litigation may well follow.

We have not seen an industry vs. FDA litigation war break out yet, but along the lines we predicted, a new Citizen Petition (“CP”) is loudly beating the drums.  As just about anyone can submit a CP to FDA on just about anything (see 21 C.F.R. §§ 10.25, 10.30), the mere fact that one has been submitted does not often rise to the level of blogworthiness.  This one is different.  Below we break down this new CP’s request, its extensive supporting rationale, and what might follow it.

The Citizen Petition’s Outward Ask

On April 20, 2026, a major Washington, DC law firm submitted a Citizen Petition to FDA on behalf of “an individual pharmaceutical company,” nominally asking that FDA “establish a clear process that provides applicants with notice and an opportunity to respond to proposed disclosures of CRLs associated with unapproved” NDAs, ANDAs, BLAs, and their supplements and amendments.  Since last September, FDA has decided on its own, without applicant input, what information to redact from a CRL as confidential commercial information/trade secret information (“CCI/TS”) and when to post it on its openFDA website.  The process the CP requests would “mirror” the pre-disclosure notification process (“PDN,” as FDA sometimes calls it) that FDA already provides under 21 C.F.R. § 20.61(e) when it receives FOIA requests for records containing potentially confidential information.  In short, PDN involves providing an applicant with an opportunity to object on CCI/TS grounds to FDA’s proposed disclosure prior to the records’ release, and if the applicant and FDA do not agree on the scope of disclosure, allowing the applicant a few days before release to seek any emergency relief in court to block it.  See id.

The CP picks up steam as it goes on though, and by its end, it argues that FDA’s “recent release of CRLs for unapproved applications is unlawful and contravenes decades of agency practice with no adequate explanation,” and that “FDA should immediately cease publishing CRLs,” and “at a minimum,” “expeditiously take the steps described herein,” i.e., institute a PDN process.  Tellingly, it “reserv[es] all other rights.”

The Arguments Behind It

The CP makes many legal arguments along the lines we flagged in our earlier blog post, explaining how these CRL releases marked a departure from the agency’s longstanding position and arguing that aspects of them run contrary to disclosure statutes and FDA’s own governing regulations.  We won’t rehash all of that; instead, we’ll provide the top lines on what the CP added beyond what we wrote in our post:

• It squarely argues that these CRL releases violate federal law, including the FOIA, the Trade Secrets Act, and FDA’s regulations. Though it does not specifically accuse FDA of releasing trade secret information in a CRL thus far, it pointedly argues that such a disclosure would also amount to an unconstitutional Taking.
• It asserts that the decision to release these CRLs was “arbitrary and capricious” under the Administrative Procedure Act, because FDA did not acknowledge its change in position, adequately explain it, or consider reliance interests of industry that had come to expect that their information would remain confidential.
• It shares results of the firm’s own research that present a damning picture of FDA’s CRL releases. Most pointedly, it says that out of 127 CRLs for unapproved applications in FDA’s database, there were at least 36 for which the applications had not been previously publicly disclosed or acknowledged, in direct conflict with 21 C.F.R. §§ 314.430(b) and 601.51(b). It then calls out the scope of FDA’s CCI/TS redactions, stating that in almost half of all CRLs released, “FDA did not redact substantive deficiency information,” and explaining in further detail how in 4 of them, “FDA left unredacted detailed and confidential clinical deficiency information that is highly competitively sensitive.”
• It also raises “policy concerns,” arguing that the CRL releases allow competitors to freeride on information that it took the applicant many months or more, at significant cost, to get. Under this view, the benefits FDA touted of helping companies “‘avoid blind alleys and common missteps to accelerate development’” are in fact an admission “that disclosed CRL information will help the applicant’s competitors develop shortcuts.”  The CP also argues that negative publicity from a released CRL could reduce a drug company’s likelihood of continuing to pursue an application if public and/or private support for it wanes, based on a perhaps artificially grim picture the CRL portrays to the outside reader.  (We too previously observed the “one-sided” nature of CRLs.)  All of this, the CP argues, may stifle innovation.
• Finally, it asserts the benefits of PDN in this context, including that it would provide applicants “due process.” It is on shakier ground, however, in arguing that PDN would “reduce burdens for agency employees.”  Because FDA would still be doing the work of proposing redactions in the first instance, and then undergoing PDN’s back-and-forth with applicants who are “familiar with the confidentiality of the information that they generate” and thus “may identify key disclosure issues for the agency to resolve,” these authors don’t see how administrative burdens would be lessened by the exchange.  That said, if the goal here is to help FDA get to the right answer, and not just the fastest or least “burdensome” one, we see their point.

What May Come Next

In our view, the CP raises important considerations that it would be irresponsible for FDA to ignore.  Whether or not these CRL releases ultimately make for good policy, federal agencies must obey federal statutes and their own binding regulations, of course, and at a minimum are not expected to make major shifts in policy without soliciting prior public input.  While this CP comes seven months after FDA began releasing unapproved drug CRLs, it draws from the real world experience of the CRL releases in the intervening time. For example, it provides concrete data on CRLs that marked the first disclosure of an application’s existence and identifies specific instances in which FDA allegedly did not sufficiently redact out CCI/TS in line with governing law (discussions of specific study design deficiencies, endpoints, etc.).  These arguments were foreseeable to us and others back in September, but they now have flesh on the bones.  Finally, the CP (for the most part) offers a modest proposal for the problem: just provide applicants with PDN.

FDA takes a notoriously long time to respond to CPs, as we’ve noted before, and so it may take a while before the agency does anything with this CP.  Still, here are a few possible avenues FDA, and others in turn, might take in response:

• FDA could open a public docket to solicit further input on how to approach this important issue going forward. (Of course, if FDA were to explicitly amend its regulations, it would need to go through notice and comment rulemaking.)  Whether it does that or not, FDA is wholly in control of how and when it releases these CRLs going forward and could simply decide to “immediately” suspend that practice as requested by the CP while it considers the issues it raises — or not.
• Alternatively, other stakeholders may seek to use this already open CP docket to provide their views on the CRL releases now that the can has been opened — for and against. As we mentioned before, many drug companies are likely concerned about the information their competitors could glean from their CRLs, which previously would have been kept confidential prior to approval; but others may consider themselves benefiting on the whole from the increased disclosure by assisting them with their own drug development.  Outside interest groups could be similarly aligned in favor of greater government transparency (and less sympathetic to drug companies’ assertions of the confidential nature of the information).  So it will be interesting to see if this CP itself spurs a more robust public debate on this subject.
• FDA could implement the requested PDN procedures. Not only would this allow an applicant a say in the scope of disclosure before a CRL goes out (and potentially whether it should be published at all), but with prior notice, it would also open a very clear avenue for a company to go to court in a “reverse-FOIA” suit, i.e., one seeking that the agency be enjoined from releasing information before it happens. (We can’t help but note, though, that an applicant who sues to keep the existence of their application hidden would have a trickier go of that through a public lawsuit.)
• And if FDA does nothing, or drags its feet too long, the CP is a clear shot across the bow, containing many arguments that easily could be repurposed into a Complaint suing the agency — whether by this Petitioner or others following its roadmap. Indeed, the CP argues that implementing its proposals “could also help reduce the agency’s litigation risk as well as the risk that FDA employees violate the law — including laws with criminal penalties — in their disclosure practices.” Point made.

We will be keeping a close eye on whether FDA continues along its current path of releasing CRLs notwithstanding this CP; if so, whether a litigation war breaks out; and if so, who will be the first to enter the breach.