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When the SEC announced that it had entered into a cooperative Memorandum of Understanding with the FDA to facilitate information sharing to improve the agencies’ regulatory and enforcement responsibilities, I think many practitioners were wondering whether this was a formalization/codification of current practices or an expansion of cooperation, how the MOU would change the agencies’ current communication in practice and what it means for life sciences companies. This Goodwin alert gives us the lowdown.

Interagency cooperation between the SEC and FDA is not new. In 2004, the agencies announced a collaboration to make referrals and exchanges of nonpublic information more efficient, relying on designated contacts and existing statutory and regulatory authorities. The SEC Enforcement Manual (the “Manual”) describes the resulting process. Staff considering a request to the FDA were expected to consult supervisors, notify the Division of Enforcement’s FDA liaison, and assess the statutes governing FDA disclosure. The Manual cautions, however, that requests should be tailored, that substantial time should be allowed for FDA review, and that the company’s consent to further disclosure of its confidential commercial information should be sought early.

The MOU does not “create enforceable rights or obligations” but should improve consistency by establishing certain contacts and procedures to be followed when sharing nonpublic information

Standing channels and accountable contacts. Each agency is to establish a mechanism to receive requests and a secure means to transmit nonpublic information. The SEC’s principal contacts include representatives from the Division of Enforcement and the Division of Corporation Finance; the FDA’s include a representative from the Office of the Chief Counsel.

A defined request-and-response process. A request must describe the information sought and its intended use, be signed by an authorized official, and, for SEC requests, include the required nondisclosure assurance. The agencies commit to timely responses and may develop standard operating procedures and model templates.

Express use in filing reviews and enforcement matters. The MOU confirms that the SEC may use nonpublic FDA information in public company filing reviews and in enforcement investigations and resulting enforcement actions. Including the Division of Corporation Finance is significant: FDA information may influence disclosure review before or apart from an enforcement investigation, and a filing-review issue can lead to an enforcement referral.

Two-way sharing with confidentiality safeguards. Consistent with statutory and regulatory limitations on the ability of the SEC and the FDA to share information with other agencies, the MOU provides that both agencies must restrict access to personnel who need the information, preserve applicable privileges, and coordinate on third-party demands. The providing agency retains a central role in responding to Freedom of Information Act requests, subpoenas, and other efforts to obtain shared material, and the SEC must also obtain permission from the FDA before sharing non-public materials obtained from the FDA with third parties.

Important limits remain. Although the FDA may refer potentially violative conduct to the SEC, the MOU does not authorize the FDA to share with the SEC information that governing statutes prohibit it from disclosing. For example, Section 301(j) of the Federal Food, Drug, and Cosmetic Act restricts disclosure of proprietary manufacturing methods or processes contained in drug applications or FDA inspection materials. The MOU also does not cover public information, testimony requests, or subpoenas, and it does not govern requests made before August 31, 2026.

While I bet most life sciences companies were aware or assumed that the Division of Enforcement was able to get nonpublic information from the FDA, I also bet that more life sciences companies were not aware that Corp Fin is part of this information-sharing process and that information provided by the FDA may result in a comment during a filing review by the Disclosure Review Program. That doesn’t necessarily change things for public companies — this MOU does not create any new public company obligations, and most life sciences companies already have disclosure controls in place to validate their public statements against regulatory correspondence to ensure their disclosure is accurate, complete and not misleading — but it’s good to be aware of.

On the enforcement side, the alert highlights an important point about the Wells process. As it notes, the SEC has recently worked to improve transparency in the Wells process, but that transparency may not always be able to extend to information provided to the Enforcement Staff by the FDA.

Under the MOU, the SEC may more easily obtain nonpublic FDA information, but it may not disclose that information outside the agency without the FDA’s written permission. The MOU provides that the FDA will respond promptly to permission requests, but obligates the FDA to grant permission only when disclosure is compelled by law or judicial order. The result is a potential information gap at the most important pre-charge stage. The SEC staff may know that the FDA record undercuts a company’s public account while the Wells recipient sees only a description of the evidence, selected nonrestricted material, or documents already in the recipient’s possession. The problem may be most acute for individuals who do not control the company’s complete FDA file, or when FDA records contain third-party information or require extensive review before the agency will authorize access.

The MOU also does not specify how the SEC should proceed if the FDA declines or delays permission, whether the SEC staff should segregate FDA materials from the Wells file, or how much detail staff should provide about information it cannot share. Counsel representing life sciences companies and their executive officers should raise access issues early: Identify the FDA materials likely to be relevant, ask what FDA-originated information the staff considered, and request that the SEC promptly seek FDA permission to share materials in the Wells file.

– Meredith Ervine