FDA and SEC Announce Coordination on Scrutiny of Public Disclosures

Disclosures related to development milestones and dealings with the U.S. Food and Drug Administration (FDA) are critical for life sciences companies, particularly those that do not yet have FDA-approved products. It is just as critical to approach these disclosures with care, given that they have long been subject to significant scrutiny by FDA, the U.S. Securities and Exchange Commission (SEC), and plaintiffs’ class action attorneys.

A memorandum of understanding (MOU) recently signed by FDA and SEC underscores this point. The MOU’s stated purpose is “to facilitate the exchange of information … related to FDA-regulated products and activities” and to “establish a framework to support the parties’ respective regulatory and enforcement responsibilities and otherwise enhance cooperation.” The MOU took effect on signature and runs for three years, subject to extension or modification by mutual consent and to termination by either agency on 30 days’ notice. By its terms it creates no binding obligations, and it does not change what public companies must disclose or when.

A key aspect of the MOU is recognition that FDA and SEC may exchange nonpublic information, such as FDA correspondence, meeting minutes, and complete response letters that are often summarized only at a high level in a company’s public disclosures. For example, the MOU notes that FDA may generally provide SEC with “any FDA record otherwise exempt from public disclosure” under the Freedom of Information Act, subject to certain statutory limitations. In turn, SEC may use nonpublic information received from FDA to inform its review of public company filings “to ensure compliance with the federal securities laws and in connection with any enforcement investigation, proceeding, or civil action within the SEC’s jurisdiction.” Notably, SEC’s designated points of contact under the MOU sit in both the Division of Enforcement and the Division of Corporation Finance’s Disclosure Review Program. FDA information may therefore inform routine filing reviews and comment letters, not only enforcement investigations.

Even as the current SEC has narrowed its enforcement focus, disclosures concerning FDA interactions and drug-development milestones have continued to receive scrutiny. This administration’s recent actions involving a number of life science companies and/or their officers have focused on alleged misstatements or omissions concerning FDA feedback, clinical data, efficacy, and regulatory readiness. Viewed in that context, the MOU can be seen as a natural outgrowth — and potentially an expansion — of an area that has remained important to the SEC notwithstanding the broader enforcement pullback.

This is not entirely new; FDA and SEC announced in 2004 that they had exchanged letters memorializing processes for FDA sharing of nonpublic information with SEC as well as an FDA procedure for “referring to the SEC staff possible instances of securities laws violations.” The new announcement does, however, suggest that there may be heightened scrutiny by and greater coordination between the two agencies than we have seen in recent years.

Accordingly, the MOU underscores the need for accurate company disclosures about products, regulatory engagement, and related events because companies should expect SEC to have access to the full FDA record and to compare public statements against it. Companies should also read the MOU alongside FDA’s July 2025 decision to publish complete response letters. As we noted there, that program already gives the plaintiffs’ bar a public record against which to test company statements that characterize FDA communications or refer to alignment with FDA or confidence in approval. The MOU gives SEC a comparable, and broader, nonpublic record.

From the FDA side, FDA can also raise specific concerns to SEC regarding potential inaccuracies in public statements. Indeed, we are aware of numerous recent instances where FDA has notified companies of investor-focused press releases and similar communications that the agency considered to be false, misleading, or otherwise problematic. Public companies should expect that FDA will be notifying SEC in these situations.

This will serve as an additional tool for SEC to identify disclosure issues. Further, as FDA reviews a broad subset of materials, which include clinical trial materials and social media statements, FDA may identify additional areas for SEC scrutiny.

In turn, SEC information sharing could alert FDA to potential compliance issues that could trigger FDA inspection or other regulatory action.

Public companies should expect their disclosures of FDA interactions and materials to be subject to increased scrutiny by both SEC and FDA. Companies should continue to ensure that FDA-related disclosures (including earnings call scripts, investor presentations, and press releases) align with the underlying FDA correspondence and minutes and that disclosure controls promptly capture significant FDA communications. Further, companies should be prepared for enhanced FDA oversight because of issues identified by SEC.