The FDA and SEC are stepping up coordination over public disclosures concerning FDA-regulated products. A new memorandum of understanding (MOU) provides a framework for the agencies to share information—including nonpublic FDA correspondence, meeting minutes, and complete response letters—for use in SEC filing reviews and enforcement investigations.

The agreement gives the SEC greater ability to compare companies’ public statements about FDA interactions, clinical data, and regulatory milestones against the underlying FDA record. Information sharing can also flow in the other direction, potentially prompting FDA scrutiny based on issues identified by the SEC.

Public companies, particularly in the life sciences sector, should expect increased scrutiny of FDA-related disclosures. Read our latest post for more on the new framework and its enforcement implications.