A Direct Line Between Regulators: What the New SEC-FDA Information-Sharing MOU Means for Life Sciences Companies

On August 31, 2026, the Securities and Exchange Commission (SEC) and the Food and Drug Administration (FDA) announced a memorandum of understanding (MOU) that formalizes and streamlines existing interagency cooperation practices by establishing a written framework for sharing information about FDA-regulated products, companies, and individuals. The MOU is intended to support both agencies’ regulatory and enforcement responsibilities, including the SEC’s review of public company filings and related investigations and resulting enforcement actions. It applies to interagency requests made after August 31, 2026, and remains in effect for three years.

For life sciences companies, the MOU is of critical importance because FDA-related developments often implicate the federal securities laws. Clinical data, FDA feedback, inspections, and agency decisions can move stock prices dramatically, and often trigger disclosure obligations. The SEC has brought a myriad of actions against life sciences companies and their executive officers arising from interactions with the FDA. The MOU expressly recognizes that it is designed to address situations where an FDA-regulated company may have disseminated false or misleading statements to the investing community about matters within the FDA’s regulatory authority. Although information sharing between these agencies is not new, a formalized reliable channel to obtain FDA-related information should allow the SEC to more effectively and efficiently test an issuer’s public narrative against the underlying regulatory record.

The MOU, however, does not eliminate the confidentiality rules that have historically complicated SEC access to FDA records. Nor does it guarantee that the recipient of a Wells notice — i.e., the letter informing a company or individual that the SEC staff intends to recommend that the Commission institute an enforcement action and affording the recipient an opportunity to respond — will be able to review complete FDA materials in the investigative file. That limitation is in tension with the SEC’s updated Wells procedures announced in February 2026, which encourage the staff to permit review of relevant portions of the investigative file unless the material is privileged or otherwise restricted. The MOU may thus improve the SEC’s access to FDA material without producing an equivalent improvement in an investigated party’s access.

Why Information Sharing Matters in Life Sciences Enforcement

The FDA and SEC approach the same underlying events through different regulatory lenses. The FDA focuses on promoting and protecting public health by ensuring the safety, efficacy, and security of regulated products. The SEC focuses on investor protection, market integrity, and the federal securities laws. For life sciences companies, those interests frequently converge on the same underlying facts. The convergence is especially pronounced when an issuer describes interactions with the FDA in public filings or statements. A statement may be literally accurate, yet the SEC may deem it misleading if it omits qualifying feedback or unresolved deficiencies. Once a company speaks about a regulatory development, the primary question is often whether the statement fairly conveys the feedback in light of the full regulatory record.

The SEC’s enforcement track record illustrates the point. In recent years, the SEC has charged life sciences companies and their executives when public statements allegedly diverged from the underlying FDA record. Those matters have included alleged failures to disclose clinical holds before raising capital, promotion of favorable efficacy data points after learning the FDA disagreed with the methodology, and characterization of agency meetings as positive despite significant objections or disagreements about a company’s product development plans. The SEC also has brought insider trading cases involving nonpublic clinical results. By obtaining information directly from the FDA, the SEC can compare public statements with agency correspondence, meeting records, and findings. The contemporaneous agency record thus may reveal differences between what the FDA communicated, what company personnel understood, and what investors were told. It may also shed light on what company insiders knew when they traded in company stock.

Prior Practice

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 New MOU

The MOU supplements and seeks to streamline the prior practice with a written, bilateral operating framework. Although it does not create enforceable rights or obligations, it establishes a standard process for requesting, transmitting, using, and protecting nonpublic information. Importantly, by centralizing the process through designated contacts and uniform procedures, the MOU also should promote greater consistency within the Division of Enforcement when seeking FDA information. This should reduce the variability that often characterized the prior, more ad hoc approach.

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.

Access to FDA Materials in the Wells Context

In February 2026, the SEC revised its Manual to promote a more uniform Wells process. Among other changes, the Manual encourages the SEC staff to make reasonable efforts to permit review of relevant portions of the investigative file, on the premise that meaningful access to the evidence improves the quality of both the submission and the staff’s recommendation.

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.

Key Takeaways

• Assume the agencies can compare the public story with the FDA record more quickly. Public statements about clinical data, FDA feedback and interactions, application review status, inspections, and approval prospects should be evaluated against the complete contemporaneous record — not merely against the subset likely to be public.
• Treat the Division of Corporation Finance as part of the information-sharing architecture. The MOU is not limited to the Division of Enforcement. FDA information may inform a filing review, generate comments about risk-factor or business disclosures, or contribute to a later enforcement referral.
• Plan for the Wells access problem before a notice arrives. The MOU streamlines agency-to-agency sharing but preserves FDA control over further disclosure. Companies should maintain a complete, organized, and accessible copy of their own FDA record, and counsel should seek targeted access and necessary permissions early enough to address FDA material within the SEC’s Wells timetable.
• Do not overstate what the MOU changes. The MOU establishes a formal pathway for interagency cooperation, not a waiver of existing statutory protections.