SEC, FDA Formalize Cooperation on Public Company Disclosures
The two agencies have established a new framework for sharing non-public information, signaling a potential uptick in SEC enforcement actions concerning clinical trial data, product approvals, and safety matters.
The U.S. Securities and Exchange Commission and the Food and Drug Administration entered into a Memorandum of Understanding on August 31, 2026, to formalize and enhance cooperation and information sharing. The agreement establishes a direct channel for the agencies to exchange non-public information, increasing the likelihood that the SEC will scrutinize company disclosures against data submitted to the FDA.
For sophisticated counsel and their clients in the life sciences, pharmaceutical, and medical device sectors, this signals a heightened risk of enforcement actions. Discrepancies between statements to investors and filings with the FDA regarding clinical trials, regulatory approval status, or product safety could become a primary source for SEC investigations. The agencies have created dedicated points of contact to streamline the process. FDA-regulated public companies should immediately review their disclosure controls and procedures to ensure consistency and accuracy across all regulatory and financial reporting. Counsel should monitor for an expected increase in SEC filing reviews and enforcement activity in this area.