SEC and FDA Sign Memorandum of Understanding Regarding Information Sharing

On Aug. 31, 2026, the U.S. Securities and Exchange Commission (SEC) and Food and Drug Administration (FDA) signed a memorandum of understanding (MOU) establishing a formal framework for interagency information sharing related to FDA-regulated products and activities. The MOU was signed by SEC Chairman Paul S. Atkins and FDA Commissioner Kyle Diamantas.

For publicly traded life science companies and those preparing for an initial public offering, this is a development worth understanding.

Overview

The MOU creates a structured channel through which the FDA and SEC intend to exchange nonpublic information relevant to their respective mandates of safeguarding public health and the integrity of the financial markets. The collaboration is intended to “bolster informed decision-making, improve the effectiveness of the parties’ oversight and compliance efforts, and ensure that information relevant to public health and the integrity of financial markets is appropriately shared.” In practical terms, this means the SEC can now more readily obtain FDA information to verify whether a company’s public statements about regulatory interactions, clinical trial results, the status of a product’s review or the nature of FDA feedback are accurate.

The MOU has a three-year term and may be extended, modified or terminated by mutual written consent, or by either party on 30 days’ notice.

Key Provisions

• Reciprocal Information Sharing. Where practicable, each agency intends to share with the other information regarding FDA-regulated products and activities, and the persons and firms who manufacture, distribute and sell FDA-regulated products.
• Mechanics of Sharing. Each agency will designate a mechanism for receiving and transmitting requests (e.g., a mailbox and secure file transfer). Information requests must describe the information sought and its intended use and must be signed by an authorized official.
• FDA → SEC Disclosures. The transfer of information from the FDA to the SEC is governed by 21 C.F.R. 20.85. The SEC may use nonpublic information obtained from the FDA in connection with the review of a company’s SEC filings as well as any enforcement investigations, proceedings or civil actions. However, certain trade secret and confidential commercial information subject to specific statutory prohibitions may not be shared other than as statutorily allowed.
• SEC → FDA Disclosures. The transfer of information from the SEC to the FDA is governed by 17 C.F.R. 240.24c-1, which requires FDA to demonstrate that the information is needed and to provide confidentiality assurances.
• Strict Confidentiality Controls. Shared nonpublic information must be restricted to the authorized agency officials, employees and contractors who need it for their official duties and must be properly safeguarded. The SEC cannot provide any nonpublic information received from FDA to anyone outside the SEC without FDA’s written permission. FOIA requests and third-party requests (i.e., subpoenas, discovery requests and litigation) trigger notice and additional protocols.
• Role of the FDA’s Office of Chief Counsel. The MOU establishes a formalized pipeline for the FDA to flag potential securities law violations to the SEC by tasking the FDA’s Office of the Chief Counsel to refer potential violations to the SEC.

Practical Implications for Life Science Companies

The operational significance of this MOU for life science companies can be distilled into a few key themes:

• SEC Filings and FDA Reality Are Now More Easily Cross-Referenced. The SEC’s Division of Corporation Finance already closely reviews life science companies’ disclosures with a focus on clinical and regulatory claims. The MOU gives the disclosure review staff a direct line to FDA to verify whether what a company told investors matches what the FDA’s records reflect.
• FDA Can Proactively Refer Matters to the SEC. The MOU establishes the FDA’s Office of Chief Counsel as the lead for referrals to the SEC of potential violations. If the FDA observes that a company’s public characterizations of FDA interactions diverge materially from what actually transpired, it now has a formalized mechanism to alert the SEC.
• Enforcement Investigations Will Have Better Sources. When the SEC opens an investigation into whether a biotech company overstated its regulatory progress, something that has historically required the SEC to reconstruct the FDA timeline from public records and company productions, it can now go directly to FDA for the contemporaneous record.
• Investor Communications Require Heightened Precision. Earnings calls, investor presentations, press releases and SEC filings discussing FDA interactions should be treated as statements the SEC can now readily verify against the source. The days of artful ambiguity around phrases like “clear regulatory pathway” carry incrementally more risk.
• Board and Disclosure Committee Processes Matter More. Disclosure committees should ensure that public statements about FDA interactions are reviewed by individuals with direct knowledge of the underlying agency communications. The gap between what the regulatory affairs team knows and what the IR team says should be as narrow as possible.

Key Takeaway

The MOU reinforces the critical importance of accuracy and precision when making public statements about FDA interactions. Companies should endeavor to reflect FDA communications, including, where appropriate, the FDA’s own terminology, faithfully in their public disclosures. This practice has proven particularly significant for companies facing SEC investigations involving alleged misrepresentations of FDA interactions. When a company can directly corroborate its characterizations of FDA communications through meeting minutes, written correspondence and agency records that explain regulatory path changes over time, the SEC has demonstrated a willingness to close such investigations. Maintaining rigorous contemporaneous documentation of all FDA interactions is therefore both a regulatory best practice and a meaningful risk-mitigation tool.