FDA and SEC Compare Notes: What the New MOU Means for FDA-Regulated Public Companies

On August 31, 2026, FDA and the Securities and Exchange Commission (SEC) announced a new Memorandum of Understanding (MOU) intended to enhance cooperation between the agencies and facilitate the exchange of non-public information relevant to their respective oversight and enforcement responsibilities. The agreement runs for three years and can be extended.

For publicly traded life sciences companies, the immediate implication seems obvious: SEC may have an easier way to learn what FDA knows when evaluating what a company has told investors about clinical trial results, regulatory interactions, product approvals, or other FDA-related developments.

But FDA and SEC have been sharing this kind of information for more than two decades. So, what exactly is new?

An Old Relationship Gets a New Framework

In 2004, the agencies exchanged letters formalizing procedures for coordinating when public companies made potentially false or misleading statements about FDA review or other matters within FDA’s authority (see here and here). FDA agreed to establish a centralized referral procedure, while emphasizing that its employees would not routinely police public-company statements in the ordinary course of their work. The arrangement also established FDA-designated contacts throughout the Agency to respond to SEC requests for information, contemplated FDA review of FDA-related statements in SEC filings, and provided a “blanket” authorization to certain employees to share non-public information with SEC without obtaining case-by-case authorization.

The new MOU does not suddenly open a door between agencies that previously operated in separate silos. Its significance may instead be in making an existing information-sharing relationship more formal, systematic, and easier to use. Specifically, the MOU establishes designated points of contact and mechanisms for requesting and securely transmitting information and contemplates development of standardized procedures for information sharing. It also permits information obtained from FDA to inform SEC’s review of public-company filings as well as enforcement matters. Procedures for handling Freedom of Information Act (FOIA) requests received by one agency for materials related to the other are also established.  These procedures should ensure that information about the activities of one agency is not inadvertently released by the other agency in response to a FOIA request.  For example, a broad request by a third party to the FDA about information related to an FDA-regulated company should not lead to the disclosure of information in FDA’s files that reveals the SEC is investigating that company about issues within FDA’s purview.

Would FDA Tell the Same Story?

Much of the early attention to the MOU has focused on whether it will give SEC greater visibility into clinical trial data. There are important limitations on what FDA can share. Although the federal Food, Drug, and Cosmetic Act (FD&C Act) generally permits the Agency to share nonpublic records with other federal agencies subject to appropriate confidentiality protections, in certain FD&C Act provisions, it expressly prohibits FDA from sharing trade secrets and certain confidential commercial or financial information obtained under those provisions except where disclosure is authorized by them. Most notably for drugs and biologics, the FD&C Act prohibits FDA from disclosing information obtained through the drug approval and related regulatory processes concerning a method or process entitled to trade secret protection. Similar statutory protections apply to certain confidential information concerning medical devices, tobacco products, and electronic products. Thus, the MOU does not give SEC unfettered access to all nonpublic information in FDA’s possession. The more interesting issue may be whether the MOU makes it easier for SEC to obtain FDA’s side of the regulatory story.

Public companies routinely characterize FDA interactions in press releases, investor presentations, earnings calls, and SEC filings. FDA was “supportive” of a development program. The company “reached alignment” with FDA on an endpoint. A meeting was “positive and productive.” The company remains “on track” for submission or approval. However, those statements often summarize regulatory interactions that were considerably more nuanced. FDA’s meeting minutes, correspondence, review comments, or other records may identify qualifications or unresolved issues that do not fit neatly into a brief press release or other investor-facing description.

FDA regulatory lawyers know that there can be considerable daylight between FDA “agreeing” with an approach, “not objecting” to it, and simply discussing it. The new MOU reminds companies to pay close attention to those adjectives.

That does not mean companies must disclose every question or concern raised by FDA, nor does the MOU change the legal standards governing what public companies must disclose. Determining what must be disclosed remains a securities law question, but one that benefits from close coordination with experienced regulatory counsel. Regulatory teams are particularly well positioned to assess the significance of an FDA interaction and whether a proposed public characterization accurately reflects the underlying regulatory record.

Beyond Clinical Development

The MOU may also have implications beyond clinical trial results and application review.

One of FDA’s initial points of contact under the MOU is the Associate Commissioner for Inspections and Investigations, suggesting that information sharing could extend to facility inspections and related compliance matters. That could be relevant when public companies are dealing with Form 483 observations, Warning Letters, manufacturing problems, recalls, or other compliance developments. A company and FDA may have different views about the seriousness of an observation, the adequacy of remediation, or the potential effect of a manufacturing problem on approval or supply.

The MOU does not make every FDA compliance issue an SEC issue. But companies should not assume that their FDA-facing regulatory record and their investor-facing characterization of that record will necessarily remain in separate silos.

Two Regulators, One Story

There is another aspect of the MOU worth noting: information sharing under the MOU goes both ways.

Subject to the MOU’s requirements and applicable confidentiality protections, SEC may provide non-public information to FDA as well. Thus, the agreement should not be understood solely as a mechanism for SEC to check companies’ statements against FDA’s views of the facts. In an appropriate case, information developed through SEC’s activities could potentially be relevant to FDA’s own regulatory or enforcement responsibilities.

We would not expect the MOU, standing alone, to cause an immediate overhaul of disclosure practices. It creates no new substantive enforcement authority and does not change what public companies are required to disclose. But public companies may have greater reason to involve FDA regulatory counsel in reviewing public descriptions of significant FDA interactions and to ensure that important qualifications do not disappear or become inappropriately diluted as regulatory information makes its way to management, investor relations, and securities counsel.

FDA and SEC have been comparing notes for decades. The new MOU may simply make it easier and more routine for them to do so. For FDA-regulated public companies, that is a good reason to make sure there isn’t an “FDA version” and an “investor version” of the same regulatory event.