The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025 FDA compiled and released more than 200 CRLs issued between 2020 and 2024 for approved new drug application (NDA) and biologics license application (BLA) products. Improving on past agency practice, these CRLs are now located within a single database, providing the public with easy access to a trove of information regarding FDA’s thinking when making approval decisions.
While this is not necessarily a radical step forward in FDA’s quest for transparency, it does present learning opportunities for drug and biologic developers, while also raising a number of questions regarding what is to come, including what else FDA may release going forward.
If FDA’s approach ultimately results in the expansion of published CRLs, FDA applicants—both current and past—will need to consider the ramifications, including the realms of product development and regulation, securities enforcement and litigation, and in the context of corporate transactions.
Background on FDA’s Policy for Release of CRLs
CRLs are issued by FDA when the agency determines that a pending drug or biologic application is not approvable in its current form and describe the identified deficiencies to the applicant. Historically, following approval of an application, redacted versions of FDA’s action packages, including underlying review documents and where applicable previously issued CRLs, were proactively published by FDA for certain NDAs and BLAs, including for new molecular entities and other approvals of public interest.
Although most often applying to innovator applications, this can also include follow-on applications (e.g., generic drug, 505(b)(2), 351(k) or biosimilar applications). Importantly, FDA’s historic practice has not been to release CRLs for products that have yet to reach approval. Instead, public information regarding these CLRs has typically been limited to disclosures made by the applicants themselves, whether voluntarily or in response to other regulatory requirements, including US securities laws applicable to publicly traded companies. Over the years, however, FDA has considered expanding its practices to include further release of CRLs to the public.
Drug Development and Regulation
While FDA has described the release of these CRLs as an act of “radical transparency,” much of the released information was already publicly available through FDA’s posted review documents. Even with the significance of this action being more tempered in the short term, FDA’s creation of a CRL database should still be viewed as important for drug developers.
First, the collection of CRLs in a single location may serve as a useful resource for applicants. Whereas previously sponsors would need to search through individual product packages for this information, now, with it gathered in one place, the CRLs may be able to be more easily searched, including potentially using artificial intelligence tools, to allow identification of analogous and precedential products and situations.
With this information, sponsors may be able to head off issues before they occur. Sponsors should keep in mind that, with the current shifts in agency policies, prior FDA actions should be carefully analyzed to understand the agency’s potential approach to issues today.
Second, and more importantly, FDA has indicated that additional disclosures of other CRLs are in process and should be expected by the public. FDA’s announcement does not specify if or how far back FDA will reach in publishing previously issued CRLs or going forward if or how (or how frequently) FDA will publish newly issued CRLs.
FDA also does not specify whether this additional publication will be limited only to CRLs for applications that are subsequently approved or whether it will extend to applications that are never approved. Finally, the announcement does not discuss the implications of the proactive publication of CRLs for the scope of information that requestors may be able to obtain under the Freedom of Information Act (FOIA).
While FDA has indicated that it has redacted (and presumably will continue to redact) published CRLs for trade secret and confidential commercial information, even redated CRLs can nonetheless contain what is considered to be significant competitive information about a product, the applicant, and/or its development strategies. With more and more of this information available to the public broadly, FDA notes in its announcement that it hopes that industry can learn from these disclosures.
Where FDA has or may in the future disclose CRLs, companies should be mindful of and consider the scope of any redactions, whether the redactions are sufficient to avoid disclosure of confidential and trade secret information that is exempt from disclosure under FOIA, and available options if FDA’s redactions fall short.
Securities Enforcement
As we previously highlighted, we already expected the US Securities and Exchange Commission’s enforcement priorities under the new administration to result in focus on companies in the life sciences industry and have suggested proactive steps to address and mitigate the risks of SEC enforcement interest.
FDA’s announcement may increase this scrutiny, particularly in areas of disclosures and financial fraud, potential trading abuses, and Regulation Fair Disclosure (Reg FD). The SEC typically views drug and other product developments as material to investors and has investigated both companies and related individuals for misstatements regarding the approval status of products, permissible uses of drugs, or other milestones.
The focus on this issue by FDA and any future expanded release of CRLs may invite the SEC to compare FDA’s decisions with prior company disclosures. Indeed, FDA’s announcement seemingly invites this review through its references to sponsors who “misrepresent the rationale behind FDA’s decisions to their stakeholders and the public.”
Moreover, the release of decision letters will invite whistleblowers and other constituents to submit complaints to the SEC regarding companies’ disclosures related to their drug and other product developments. This in turn may result in the SEC opening more investigations in this space.
In addition to disclosures, the SEC and Financial Industry Regulatory Authority already focus their highly sophisticated surveillance tools on monitoring trading activity around key events such as FDA decisions announced by companies. Any increased public access to the actual decisions and their rationale would advance the SEC’s ability to analyze trading by company insiders and consultants, as well as their family members and friends, ahead of and around company announcements and FDA’s own releases of information.
Relatedly, even in the absence of suspicious trading, the SEC has charged companies with selectively disclosing material nonpublic information to favored analysts or investors without broadly disseminating the information to the public, which is required under Reg FD. The public sharing of FDA decisions may increase SEC interest in this area as well, as the SEC could seek to determine whether companies shared information regarding FDA decisions with select investors or analysts before the information was provided to a broader retail investor base.
As we previously highlighted, there are proactive steps companies can take to mitigate the risk of SEC interest, including periodically reviewing their FDA-related disclosures, implementing and regularly revisiting policies and procedures regarding insider trading and Reg FD, and conducting and regularly updating training on these topics.
Corporate Transactions
In addition to the increased securities scrutiny and other disclosure matters, the implications of FDA potentially expanding the scope of disclosed CRLs will impact the diligence, negotiation, and drafting of corporate transactions in the life sciences sector. In both M&A and licensing/collaboration transactions there will be higher scrutiny and attention during the diligence phase as there will now be heightened concern that more information will be made publicly available.
These additional diligence matters will need to be translated into representations and warranties that the acquiror/licensee will insist on making part of the transaction documents and that the seller/licensor will want to limit for breach concerns and damage limitations. Indemnification provisions will need to be reevaluated to account for shareholder suits and investigations resulting from a company not adequately disclosing information that was in a CRL but is now available to the public upon publication by FDA.
Finally, given the potentially highly sensitive nature of information that can be contained within a CRL, if information is made publicly available that otherwise would have been the confidential information of a party to a transaction, parties will have to consider what ability they have to use such information and how that may impact any exclusivity or noncompete provisions that will need to be considered and addressed in life sciences transactions.