The SEC and FDA are deepening their coordination and likely sharpening their attention on healthcare disclosures. The agencies’ new information-sharing framework could increase scrutiny of public-company statements concerning FDA-regulated products, regulatory approvals, clinical trials, and safety matters. Against that backdrop, on August 31, 2026, the SEC and the FDA announced that they have entered into a Memorandum of Understanding (MOU) designed to assist the agencies in carrying out their respective missions of ensuring the integrity of the financial markets and protecting public health. The MOU establishes a framework for the agencies to enhance cooperation in their regulatory and enforcement responsibilities and, notably, includes information-sharing protocols to facilitate the exchange of nonpublic information between the SEC and FDA. This MOU comes amid reports that Trump administration cuts have compromised food safety and an expressed focus by the DOJ on healthcare.
SEC Chairman Paul Atkins said that “FDA-related disclosures by public companies have a significant impact on our markets” and that the “FDA is a valuable partner in our efforts to administer and enforce applicable disclosure requirements under the federal securities laws.” Acting FDA Commissioner Kyle Diamantas similarly noted that “[s]treamlining our information-sharing helps protect both the patients who rely on FDA-regulated products and the public trust that drives healthcare innovation.”
What the MOU covers
The MOU is aimed at facilitating the exchange of information related to FDA-regulated products and activities, including information about persons and firms who manufacture, distribute, and sell those products. In practice, this means the SEC and FDA intend to share information that is relevant to their respective oversight of public companies operating in the life sciences sector—including matters such as the status of FDA review, product approvals, clinical trial results, and other issues within the FDA’s regulatory authority that could affect investors’ decisions.
Information-sharing mechanics
Each agency will establish a mechanism, such as a mailbox, for receiving requests for information and a mechanism for providing nonpublic information, such as via secure file transfer. Each agency will also maintain at least one principal point of contact (POC) to facilitate cooperation. Specifically, the FDA’s Office of the Chief Counsel will serve as the FDA’s lead for referrals to the SEC of potential violations, and the SEC will have POCs in both its Division of Enforcement and its Division of Corporation Finance.
Confidentiality protections
The MOU includes robust confidentiality provisions governing the treatment of shared nonpublic information. In particular:
- When FDA shares nonpublic information with the SEC, the SEC may use it to inform public company filing reviews and in connection with enforcement investigations, proceedings, or civil actions, but cannot further disclose it to any person who is not an officer, employee, or contractor of the SEC without FDA’s written permission.
- When the SEC shares nonpublic information with the FDA, it will continue its practice of obtaining assurances of confidentiality pursuant to customary access requests and grants.
- FDA will not share trade secret or confidential commercial information that is prohibited from disclosure under the Federal Food, Drug, and Cosmetic Act, except as allowed by the applicable statutory provisions.
Duration
The MOU became effective upon execution on August 31, 2026, and will remain in effect for a period of three years. It may be extended, modified, or terminated by the parties’ mutual written consent and may be terminated upon 30 days’ advance notice by either party.
Key takeaway
The MOU signals a closer working relationship between the SEC and FDA, particularly with respect to enforcement matters involving public companies engaged in FDA-regulated activities. Those companies should be aware that information shared with or obtained by the FDA may now be more readily available to the SEC in connection with disclosure reviews and enforcement actions, and vice versa. FDA-regulated public companies should closely review their disclosure practices to ensure any public statements regarding FDA-regulated products, clinical trials, regulatory approvals, and other related matters are accurate, complete, and consistent with information provided to the FDA.
Ultimately, the MOU could signal an uptick in related enforcement actions at the SEC. We will continue to monitor how this enhanced cooperation affects the SEC’s enforcement agenda and plays out in practice.
