SEC-FDA MOU Formalizes Nonpublic Information Sharing Framework
A new SEC-FDA memorandum of understanding creates a formal channel for exchanging nonpublic information on FDA-regulated products, with direct implications for issuer disclosure workflows.
The SEC and FDA have signed a memorandum of understanding setting out a framework for exchanging nonpublic information about FDA-regulated products and the companies that make and sell them. Arnold & Porter's analysis describes the MOU as a formalized structure enabling each agency to draw on information that is not publicly available. For counsel, the practical significance is likely to surface in disclosure workflows rather than in headline enforcement: issuers and underwriters already operate under securities-law confidentiality constraints when they receive material nonpublic information, and those same companies often have concurrent FDA-facing discussions about products, safety, labeling, or enforcement status. A formalized regulator-to-regulator channel raises questions about how information travels inside a company, which advisers see it, and whether disclosure obligations are implicated by what an agency learns. Sophisticated counsel will need the MOU's actual text and any implementing procedures before drawing conclusions, because the available summary does not describe scope, permitted uses, or safeguards. Worth watching: any public guidance on the arrangement and how it is applied in registration statements, periodic reports, and voluntary disclosures.