SEC, FDA Ink Deal to Share Non-Public Company Data
A new memorandum of understanding gives the SEC a formal channel to obtain confidential FDA records, increasing scrutiny of public disclosures by life sciences companies.
The U.S. Securities and Exchange Commission and the Food and Drug Administration have established a formal framework for sharing non-public information. An August 31, 2026, memorandum of understanding (MOU) gives the SEC’s divisions of Enforcement and Corporation Finance a direct channel to request and receive confidential records from the FDA concerning regulated public companies. For life sciences and other FDA-regulated issuers, this significantly raises the stakes for public communications. The SEC can now more easily cross-reference a company's investor-facing statements—regarding clinical trial results, product approval timelines, or the substance of agency meetings—against the FDA's own internal records. The MOU is part of a broader FDA transparency initiative, which includes the recent practice of publishing Complete Response Letters. The agreement heightens the risk of SEC scrutiny and potential enforcement action for disclosures that are perceived as incomplete, inconsistent, or more favorable than the underlying regulatory communications warrant. Companies must ensure all public statements about FDA interactions are meticulously aligned with the official record.