Overview
In a marked departure from long-standing practice, the US Food and Drug Administration (FDA) has begun publishing stand-alone complete response letters (CRLs), formal communications that detail the deficiencies in a drug application preventing its approval. The FDA stated that this policy shift is intended to enhance regulatory transparency and consistency and could help guide the industry in structuring future clinical studies and FDA submissions. This change carries important legal and strategic implications, especially for public company sponsors that might need to alter their approaches to disclosure obligations in future securities filings.
Background
To obtain FDA approval for a new pharmaceutical product, sponsors are required to compile and submit applications containing comprehensive product information to the agency. These applications typically compile an array of data critical to the FDA’s evaluation of whether the new product meets regulatory standards, such as a description of the product’s chemical properties, research studies supporting the product’s safety and efficacy, details on the manufacturing process, and proposed packaging and labeling for the product. In situations where the FDA cannot approve a product based on the information provided in a sponsor’s initial application, the agency may issue a CRL to the sponsor. A CRL describes any deficiencies identified in the application and often suggests a course of action that the sponsor can take to bolster the product’s likelihood of approval. After receiving a CRL, a sponsor may choose to respond to the FDA’s suggestions and submit an updated application for review or request an administrative hearing to contest the denial.
In Depth
Because of the sensitive commercial information CRLs might contain, the FDA has historically treated CRLs as confidential documents and refrained from publishing them unless part of a product’s final approval package. Although it has been common practice for sponsors to announce receipt of a CRL, the FDA’s position on confidentiality has left sponsors with broad leeway to decide how to characterize the agency’s primary reasons for issuing the CRL and its proposed remedial actions.
Two press releases from July 2025 and September 2025 suggest that the agency believes that its historical policies have inadvertently afforded sponsors overly broad scope for “spinning” the content of unpublished CRLs, opening the door for sponsors to underplay legitimate concerns and otherwise withhold the important information CRLs contain. According to the FDA, this is not an isolated matter involving only a few entities. Internal analysis conducted by the agency in 2015 found that “sponsors avoided mentioning 85 percent of the FDA’s concerns about safety and efficacy” when publicly announcing their CRLs.
Over recent months, to improve transparency for both industry actors and consumers, the FDA has moved away from its past reluctance to publish CRLs because of their presumed sensitivity and decided to publish close to 300 such letters issued between 2020 and 2025. The published CRLs relate not only to drugs that were ultimately approved, but also in some cases to those with pending or withdrawn applications. The FDA announced that it will begin publishing future CRLs in real time, soon after they are delivered to sponsors. Both previously issued CRLs and future CRLs will be available to the public on the openFDA website.
By normalizing the publication of CRLs, the FDA will enable sponsors to better navigate the development and application processes and avoid common pitfalls that might unnecessarily burden their resources or otherwise delay the speed at which their product is approved. For example, published CRLs might reveal that FDA has consistently taken issue with a particular study design or objected to the lack of certain controls in a proposed manufacturing process. By learning from and acting on such insights, sponsors will be able to more effectively construct their own clinical trials and submissions ex ante, anticipating otherwise difficult-to-predict obstacles along the FDA’s review path and saving valuable time and capital.
More broadly, the published CRLs may serve as an important indicator of FDA’s review priorities, keying sponsors in not only to the areas of their application that are more likely to receive agency pushback, but also to those that appear less important to the FDA’s ultimate disposition. Greater access to published CRLs could give sponsors a tool to contest denials more effectively, as they will become better equipped to scrutinize past FDA decisions for inconsistent treatment.
The FDA’s move to publicize CRLs may also prompt publicly traded sponsors to reevaluate how they disclose CRLs in their regulatory filings. Under securities laws, public companies must ensure that their public filings are truthful and non-misleading. Failure to do so, including by misrepresenting the contents of CRLs, could expose sponsors to potential liability in the form of shareholder class actions or government enforcement.
Because the FDA’s historical practice was to wait until a drug was approved to publish any associated CRLs, the first developers of a new product were able to exploit the significant lag time between a CRL’s issuance and its public availability. For example, even if a company glossed over a CRL in its disclosures, there was a very real chance that any issues or inconsistencies would be resolved over the next several years before the CRL’s publication or would simply go unnoticed by would-be plaintiffs. However, the FDA’s recent move to facilitate access to CRLs might alleviate some of the practical burdens for potential plaintiffs, encouraging closer scrutiny of disclosures and an elevated risk of litigation.
Additionally, for public companies that voluntarily provide details in their disclosures related to their FDA applications, the agency’s new policy to promptly publish CRLs for unapproved products could entice the US Securities and Exchange Commission (SEC) to assess the accuracy of the information disclosed to investors prior to the release of the CRLs. The new SEC leadership continues to police FDA-related disclosures. Companies should reexamine their disclosure practices to account for CRL publication.
Sponsors that believe a CRL discloses sensitive commercial information should proactively contact the FDA to request appropriate redactions under the Freedom of Information Act before the CRL’s public release.
Next steps
We will continue to monitor the FDA’s publication of CRLs and broader initiatives to promote regulatory transparency. If you have questions about how these initiatives might affect your business or its public filings, please contact a member of McDermott Will & Schulte’s Food, Drug & Medical Device Group or its Capital Markets & Public Companies Group.