On August 31, 2026, the U.S. Securities and Exchange Commission (SEC) and the U.S. Food and Drug Administration (FDA) announced a memorandum of understanding (MOU) that establishes a framework for the two agencies to exchange non-public information concerning FDA regulated products and the companies and individuals engaged in their manufacture, distribution and sale.1 The MOU has important implications for how life sciences and other FDA-regulated companies manage disclosures related to FDA interactions, because the SEC now has a formalized channel to obtain non-public FDA information that may be relevant to the SEC’s review of public company filings as well as its enforcement and investigative activities.
Dedicated Points of Contact and Formal Request Infrastructure
Signed by SEC Chairman Paul S. Atkins and Acting FDA Commissioner Kyle Diamantas, the MOU takes immediate effect and will run for three years, subject to renewal, modification or termination by the agencies. The MOU operationalizes cooperation through designated points of contact and directs the agencies to develop standardized procedures and model request and transmittal templates rather than rely on ad hoc requests. The FDA’s points of contact include the Office of the Chief Counsel and the Office of Inspections and Investigations. The SEC contacts reside in both its Division of Enforcement and its Division of Corporation Finance, Disclosure Review Program.
The MOU also provides that the agencies will notify each other promptly of any third-party attempt (e.g., subpoena, Freedom of Information Act request, litigation demand) to compel disclosure of shared information.
The Focus Is on the FDA Providing Information to the SEC
The MOU creates parallel but distinct legal pathways for sharing information. FDA disclosures to the SEC are governed by 21 C.F.R. § 20.85, which generally permits the FDA to share otherwise non-public records with other federal departments and agencies, subject to provisions of the Federal Food, Drug, and Cosmetic Act governing trade secrets and confidential commercial information.2 SEC disclosures to the FDA are governed by 17 C.F.R. § 240.24c-1 and require a showing of need plus assurances of confidentiality.3
While outlining reciprocal information-sharing between the agencies, the thrust of the MOU is the provision of FDA information to the SEC. Notably, the background section of the MOU identifies “representations about the status of FDA review, product approvals, clinical trial results, or other matters within the FDA’s regulatory authority that could affect investors’ decisions” as a topic of SEC concern.4
Critically, the SEC cannot redistribute FDA-sourced non-public information beyond SEC personnel without the FDA’s written permission, and shared information does not constitute public disclosure or waive any applicable privilege.
Alignment With the FDA’s Complete Response Letter Transparency Initiative
The MOU also complements the FDA’s ongoing effort to proactively publish Complete Response Letters (CRLs) for certain marketing applications for drugs and biological products. Beginning in July 2025, the FDA released an initial batch of more than 200 redacted CRLs issued from 2020 to 2024. In September 2025, the agency announced that—contrary to past practice—it will publish future CRLs in real time upon issuance while also releasing a further batch of previously unpublished letters related to pending or withdrawn applications. The FDA has framed this initiative as part of a “radical transparency” agenda intended to ensure “sponsors provide complete and contextualized information in communications to investors and shareholders.”5 Taken together, the MOU and the CRL disclosures give the SEC increased visibility into the FDA’s ongoing assessment of a sponsor’s applications.
Key Takeaway
The stated purpose of the MOU is to “enhance cooperation” and support “informed decision making,” but its background discussion and the agencies’ public statements point to a more specific concern: that public companies with FDA-regulated products might otherwise describe FDA feedback to investors in terms that are more favorable, or less complete, than what the underlying (and previously confidential) FDA records indicate. By giving the SEC’s Division of Corporation Finance and Division of Enforcement a formal channel to obtain FDA meeting minutes, correspondence and other communications, the MOU is designed to address perceived/potential gaps in companies’ public characterizations of FDA interactions. These new developments emphasize the importance of life sciences clients treating all public statements regarding FDA meetings, CRLs, review timelines and correspondence as subject to potential confirmation against the FDA’s internal records. Clients must, as always, ensure that all communications describing or relating to FDA interactions are accurate, complete and consistent with the underlying regulatory record.
