On August 31, 2026, the Food and Drug Administration (FDA) and the SEC announced a memorandum of understanding (MOU) that formalizes and streamlines existing interagency cooperation practices by establishing a written framework for sharing information about FDA-regulated products, companies, and individuals. The MOU is intended to support both agencies’ regulatory and enforcement responsibilities, including the SEC’s review of public company filings and related investigations and resulting enforcement actions. It applies to interagency requests made after August 31, and remains in effect for three years. The MOU confirms that the SEC may use nonpublic FDA information in public company filing reviews (e.g., registration statements and Forms 10-K) and in enforcement investigations and resulting enforcement actions. Including the Division of Corporation Finance is significant: FDA information may influence disclosure review before or apart from an enforcement investigation, and a filing-review issue can lead to an enforcement referral.
Our client alert on this topic provides more details regarding this important development.