On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological products. According to FDA, the “initial batch” of CRLs are “associated with since approved applications,” and the Agency is “in the process of publishing additional CRLs from its archives.”
FDA issues CRLs to sponsors when FDA completes a review cycle and determines that it cannot approve a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA). CRLs identify what FDA views as application deficiencies, such as safety or efficacy concerns, manufacturing deficiencies, and bioequivalence issues.
In its announcement, FDA stated that the objective of publishing the letters was two-fold. First, the move was intended to give the public “significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved.” According to FDA, this information may be able to prevent companies from making similar mistakes.
Second, the move was targeted at providing “capital markets” more “predictability.” FDA implied that publishing the CRLs was necessary “because sponsors often misrepresent the rationale behind FDA’s decision to their stakeholders and the public.”
FDA’s decision to publish CRLs in this manner is a significant departure from past practice. Indeed, there are instances where FDA’s disclosure of CRLs may be unlawful. FDA’s own regulations prohibit the disclosure of the existence of a marketing application, such as an NDA, ANDA, or BLA before approval (or tentative approval) unless the existence of the application “has been previously publicly disclosed or acknowledged.” 21 C.F.R. § 314.430(b); see also 21 C.F.R. § 601.51(b). FDA’s presumption is that the existence of an application, at that time, is confidential commercial information. 60 Fed. Reg. 43351, 43359 (July 20, 2004) (citing 21 C.F.R. §§ 20.61, 601.51). As a practical matter, these regulations also bar the disclosure of a CRL – prior to the approval of an application if the existence of the application has not been publicly disclosed or acknowledged – because such disclosure would also disclose the existence of a marketing application.
FDA has long been under pressure to release CRLs, by those who believe that it would help members of industry learn from their competitors’ mistakes, and speed drugs to market. This pressure, at least in part, may be due to the fact that the European Medicines Agency already publishes data from all opinions on marketing authorization applications (MAAs), including negative opinions.
FDA’s announcement was short on detail. It is unclear how FDA selected the CRLs that it published. Further, although FDA’s announcement said that this batch of CRLs pertained to applications submitted between 2020-2024, the release actually includes files stretching back to the early 2000s. We suspect, based on FDA’s own disclosure requirements, that there is a reason that this batch of CRLs was associated with drugs that have since been approved. Also, particularly given that some of the text in the letters has been redacted, we suspect that the CRLs published were already made public by FDA when the drugs were approved. This has led at least one observer to refer to the release as a “nothingburger.”
We disagree. Although FDA has historically included CRLs as part of drug approval packages, some of the currently disclosed letters were not already linked on the Drugs@FDA website. In addition, FDA’s publication of the CRLs in one place makes it easier for plaintiffs’ lawyers to troll for information that may help them bring shareholder lawsuits or products liability lawsuits, however unwarranted. Indeed, FDA’s assertion that sponsors often misrepresent the rationale behind FDA decision-making, seems to invite such trolling. In addition, in its announcement, FDA stated that it was in the process of publishing additional CRLs from its archives and exploring new ways of providing the public greater transparency into its decision-making process. If FDA decides at some point to publish CRLs related to products that have not been approved, there could be a significant uptick in shareholder and products liability lawsuits, and the Agency may face challenges under the Administrative Procedure Act.
