SEC, FDA Formalize Cooperation on Public Company Disclosures
A new memorandum of understanding enhances information sharing between the agencies, signaling heightened SEC scrutiny of FDA-related statements by life-sciences issuers.
The US Securities and Exchange Commission and the Food and Drug Administration signed a Memorandum of Understanding (MOU) to enhance cooperation and information sharing. Announced August 31, 2026, the agreement formalizes protocols for the FDA to provide the SEC with non-public information regarding regulated products and companies.
Sophisticated counsel care because the MOU enables the SEC to more effectively identify discrepancies between a life sciences company's public disclosures and its confidential communications with the FDA. This raises the risk of enforcement actions for misleading statements about clinical trial results, product approval timelines, or other regulatory feedback. The agreement creates dedicated points of contact within the SEC’s Enforcement and Corporation Finance divisions and the FDA's Office of the Chief Counsel, suggesting a more streamlined process for referrals and investigations. The impact may be most acute for pre-commercial companies whose market value is highly sensitive to regulatory news.
Affected companies should consider reviewing their disclosure controls and insider trading policies, and ensure close coordination between securities and FDA regulatory counsel when preparing public statements.