On August 31, 2026, the Securities and Exchange Commission (SEC) and Food and Drug Administration (FDA) released a new Memorandum of Understanding (MOU) establishing a formal framework for sharing nonpublic information concerning FDA-regulated products and activities. The MOU is notable not simply because the agencies agreed to cooperate, but because it creates the operational machinery for doing so. Each agency will establish a mechanism for receiving information requests and for providing nonpublic information. The agencies will maintain designated points of contact, including at the SEC’s Division of Enforcement and Division of Corporation Finance. The MOU also addresses timely responses, standardized procedures and templates, and follow-up discussions between the agencies. Most importantly, the MOU expressly permits the SEC to use nonpublic FDA information to inform public company filing reviews and SEC enforcement investigations, proceedings and civil actions.
The message to life sciences companies is clear: The SEC believes it needs a better window into the FDA record when evaluating what public companies are telling investors, and the agencies have now built a channel to provide it.
Key Takeaways
- The new channel is a signal. Agencies do not typically deploy resources on new programs they do not intend to prioritize or use.
- The MOU expressly identifies the disclosure problem. It refers to situations in which an FDA-regulated company may have disseminated false or misleading statements concerning FDA review, clinical trial results, the likelihood of product approvals or other matters that could affect investors’ decisions.
- FDA communications require regulatory judgment. The same question, request or concern may be routine in one context but reflect a development that should change management’s expectations in another.
- The nonpublic FDA record can tell a more complicated story than the public disclosure. Submissions, correspondence, meeting materials, agency feedback and company responses all matter.
- Companies should connect their FDA and disclosure processes. The people who understand significant FDA interactions, and are prepared to deliver the message to the affected business, should be involved when those developments are evaluated for disclosure. A disconnect can result in the release of misleading information even when everyone involved is acting in good faith.
Why the FDA Record Matters
Life sciences companies routinely have important interactions with the FDA. The agency may question a clinical endpoint, request additional information, raise a manufacturing concern or suggest that a proposed regulatory pathway requires further work. The company then has to determine what that interaction means. That can be harder than it sounds.
An FDA interaction may appear relatively benign when viewed on its own. Its significance may be very different, however, when considered in light of prior submissions and meetings, subsequent agency feedback, the company’s responses and management’s evolving expectations.
For example, consider a company that has been telling investors that it expects approval within a particular timeframe. The FDA then raises questions that cause the regulatory team to reconsider whether the existing data will be sufficient. There is no formal FDA action, but something important has happened—the company now needs to understand whether the FDA’s questions change its expectations and whether that affects what it has previously told, or will tell, its stakeholders. That is a regulatory judgment.
What the MOU Changes
The MOU does not change a company’s disclosure obligations. What it changes is the information environment—specifically, the SEC’s facility of access to the information against which a company’s disclosure can be evaluated.
The SEC’s own announcement underscores why. SEC Chairman Paul Atkins stated that FDA-related disclosures by public companies have a significant impact on the markets, and the enhanced transparency will protect patients who rely on their products. Companies should therefore assume that the new channel is intended to be used.
The relevant comparison is ultimately as follows:
What the FDA said.
What the company heard.
What the company told investors.
Those three things do not have to use identical language. FDA discussions are often complex and evolving, and public disclosure necessarily simplifies a complicated regulatory process. But the company should understand any daylight between them and be able to explain it.
What Companies Should Do Now
The MOU is a good reason for public life sciences companies to look at how FDA information moves through the organization.
Know the Regulatory Record
For significant FDA matters, identify the key submissions, correspondence, meeting materials, agency feedback and company responses. The objective is not another compliance exercise, but to understand how the regulatory picture developed.
Bring Regulatory Judgment into Disclosure Decisions
When an FDA development could affect disclosure, those who understand its real world implications should have a meaningful role in the analysis.
Securities counsel can assess the disclosure implications. Management can assess the business consequences. FDA regulatory counsel can help determine what the FDA’s position really means. Those perspectives should inform the decision together.
Look Beyond Formal FDA Actions
Do not limit the analysis to approvals, complete response letters or other formal agency decisions. A significant change in management’s understanding of an FDA outlook may occur well before a formal agency action.
Review Information Controls
Because FDA developments short of formal actions may constitute material nonpublic information, companies should also understand who receives that information, when they receive it, how it is characterized internally and how it moves into disclosure and insider trading processes.
When FDA Regulatory Counsel Should Be Involved
FDA regulatory counsel does not need to be involved in every disclosure decision. But the need becomes more apparent when the FDA has provided unexpected or potentially consequential feedback, when management’s understanding of a regulatory issue has changed, when a complicated FDA interaction is being translated into a public statement or when the SEC is asking questions about an FDA-regulated activity. In those situations, the first question may not be what the company needs to disclose—it may be what actually happened on the FDA side.
The Opportunity Comes Before the Problem
The SEC and FDA have now built a formal mechanism to streamline the sharing of nonpublic information. The MOU’s structure—and its express focus on FDA-related disclosures—signals that the SEC sees value in being able to look beyond a company’s public account and understand the underlying regulatory record. Companies should take that signal seriously. They do not need to wait for an SEC inquiry to ask, “If the SEC compared our public statements with the nonpublic FDA record, would they tell the same story?” Vedder’s FDA Regulatory Strategy & Compliance practice works with life sciences companies and their advisors to understand the FDA’s position in context and assess how regulatory developments affect business and disclosure decisions. For a company facing a consequential FDA development or an SEC disclosure related to FDA-regulated activities, bringing regulatory judgment into the process early can help identify and address potential disconnects before they become problems.
