The U.S. Securities and Exchange Commission and the Food and Drug Administration signed a three-year Memorandum of Understanding on Aug. 31, creating formal channels for exchanging nonpublic information about regulated products, public companies and potential legal violations. The agreement took effect immediately and will run through August 2029 unless extended or modified by mutual written consent.
Under the MOU, the SEC may use FDA information during company filing reviews, enforcement investigations, administrative proceedings and civil actions. The FDA, in turn, will route referrals involving potential securities violations through its Office of the Chief Counsel. The SEC has designated contacts in its Division of Enforcement and Division of Corporation Finance, while the FDA will use contacts in its Office of the Chief Counsel and Office of Inspections and Investigations.
The cooperation is intended to help regulators identify inconsistencies between corporate disclosures and nonpublic FDA records, especially statements about clinical trials, FDA submissions, regulatory reviews and product approvals. SEC Chairman Paul Atkins said FDA-related disclosures can materially affect financial markets. Acting FDA Commissioner Kyle Diamantas said faster information sharing should improve transparency across the life sciences sector while protecting patients and public trust.
Shared nonpublic records remain confidential and generally require written permission before further external disclosure. The agreement does not cover public records requests, subpoenas or testimony, and it does not grant either agency new statutory powers. Either regulator may terminate the MOU with 30 days' notice. The pact does not announce an investigation or enforcement case but creates procedures that could support filing reviews and enforcement actions if corporate statements appear materially false or incomplete.
While the MOU is primarily aimed at public biotechnology, pharmaceutical, medical device and healthcare companies, its disclosure principles may resonate across the SEC's broader jurisdiction, including crypto-related enforcement where materially misleading statements can trigger antifraud liability.
