FDA and SEC Enter MOU to Establish Information Sharing Framework

By Lauren Haas on September 3, 2026

On August 31, 2026, the U.S. Food and Drug Administration (FDA) and the U.S. Securities and Exchange Commission (SEC) entered into a Memorandum of Understanding (MOU) to establish a formal framework for sharing nonpublic information between themselves related to FDA-regulated products and activities.
According to the press release, the MOU is designed to assist the agencies in “carrying out their respective missions of ensuring the integrity of the financial markets and protecting public health.” For example, the MOU will help them detect situations where a company may have made false or misleading statements to investors related to “the status of FDA review, product approvals, clinical trial results, or other matters within the FDA’s regulatory authority that could affect investors’ decisions” (see MOU, Background). Although FDA and SEC have historically coordinated in exchanging information, the MOU formalizes infrastructure that will make this exchange faster and easier.
The following are some key provisions from the MOU:
- Information Sharing: The agencies agree to share “appropriate information” related to FDA-regulated products and activities, and persons and firms who manufacture, distribute, and sell FDA-regulated products, with the other party, where practicable.
- Dedicated Points of Contact: Each agency will designate a principal point of contact to facilitate the information requests.
- Confidentiality Controls: Nonpublic information shared under the MOU may not be further disclosed without the providing agency’s written permission. The MOU includes detailed protocols for responding to FOIA requests, subpoenas, congressional inquiries, and other compulsory process. These would require prompt notification to the providing agency and cooperation in asserting the applicable privileges.
The MOU will be effective for three years until August 31, 2029, but may be extended, modified, or terminated by the agencies at any time with 30 days’ notice.
Keller and Heckman will continue to relay any developments related to FDA regulation and enforcement.