FDA and SEC Enhance Information Sharing to Scrutinize Life Science Company Disclosures
The U.S. Securities and Exchange Commission (SEC) and the U.S. Food and Drug Administration (FDA) have formalized a Memorandum of Understanding (MOU) to establish a cooperative framework for interagency information sharing. This agreement facilitates the exchange of non-public information between the two agencies. While the MOU does not introduce new disclosure obligations for public companies, it is expected to provide SEC staff with more ready access to non-public FDA information. This access will enable the SEC to evaluate whether disclosures made by FDA-regulated public companies were false or misleading. Specifically, the SEC may now compare public disclosures against FDA-facing records, including meeting minutes, regulatory correspondence, inspection reports, clinical trial data, safety reporting, and product reviews and approvals, during filing reviews, investigations, and enforcement actions. This streamlined process aims to expedite the SEC's access to information that was previously more cumberso...
