On August 31, 2026, the Securities and Exchange Commission announced that it entered into a Memorandum of Understanding (“MOU”) with the Food and Drug Administration (“FDA”) to create a framework to support the exchange of information between the two agencies regarding FDA-regulated products and activities.  The MOU is designed to enhance both agencies’ ability to carry out their respective oversight and enforcement functions.

The SEC’s mission is to protect investors, maintain fair, orderly, and efficient markets, and facilitate capital formation, while the FDA is charged with enforcing the Federal Food, Drug and Cosmetic Act, as amended (the “FDCA”), to promote and protect public health by, among other things, ensuring the safety of foods, drugs and cosmetic products, and regulating tobacco.  In the case of a public company engaged in FDA-regulated activities, the SEC is responsible, among other things, for reviewing such company’s disclosures and financial statements for false or misleading statements, including statements about FDA-regulated matters that could affect an investor’s decision to invest in the company’s securities.

Key Terms

Under the MOU, each agency will, where practicable, share information related to FDA-regulated products and activities, and persons who manufacture, distribute, and sell FDA-regulated products, with the other.  In addition, the agencies have agreed to establish a secure mechanism to share non-public information.  The sharing of non-public information under the MOU is predicated under specific provisions of the FDCA and the Securities Exchange Act of 1934, as amended (the “Exchange Act”):

  • FDA to SEC:  Pursuant to Section 20.85 of the FDCA, the FDA may share information that is exempt from public disclosure with other federal agencies except for trade secrets and confidential commercial or financial information, and the SEC may use any non-public information received from the 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. However, the SEC cannot share any such non-public information with any person who is not an officer, employee or contractor of the SEC without the FDA’s prior written consent.
  • SEC to FDA:  Pursuant to Rule 24c-1 under the Exchange Act, the SEC may, at its discretion, share non-public information with the FDA upon a showing that such information is needed, provided that the FDA provides assurances to keep such information confidential.

In furtherance of these statutory provisions, the MOU sets forth guidelines with respect to the sharing of and safeguarding of information exchanged between agencies.  The initial term of the MOU is three years and may be extended by mutual consent of the agencies.

Key Takeaways

The MOU represents a meaningful development for public companies engaged in FDA-regulated activities.  By formalizing an information-sharing framework between the SEC and FDA, the MOU may increase the likelihood that discrepancies between a company’s public disclosures and information known to the FDA will come to the SEC’s attention.  Companies operating in FDA-regulated industries should review their disclosure practices and ensure that public statements regarding FDA-regulated products, clinical trials, regulatory approvals, and related matters are accurate, complete, and consistent with information provided to the FDA. Companies should also be aware that non-public information shared with either agency may now be more readily accessible to the other in connection with filing reviews and enforcement actions.