A New Era of Regulatory Transparency: What Life Sciences Companies Should Know About the SEC-FDA’s New MOU

The SEC-FDA Memorandum of Understanding (MOU) signals more than interagency coordination. It reinforces the need for life sciences companies to align regulatory facts, investor communications, and disclosure controls with greater discipline. Here is why the agreement matters and how companies can respond proactively.

On August 31, 2026, the U.S. Securities and Exchange Commission (SEC) and the U.S. Food and Drug Administration (FDA) signed a Memorandum of Understanding (MOU) establishing a framework for exchanging information, including non-public information, about FDA-regulated products, activities and the persons and firms who manufacture, distribute and sell those products. The agreement was signed by FDA Commissioner Kyle Diamantas and SEC Chairman Paul S. Atkins, and it runs for three years.

If your company develops, manufactures or commercializes an FDA-regulated product and has public investors, the MOU is worth understanding. It does not change what the securities laws require. What changes is how readily the two agencies can compare notes.

What the SEC Says It Is Looking For

Many interagency agreements are vague about purpose. This one is specific. In its background section, the SEC identifies the precise fact pattern it has in mind: a firm engaged in FDA-regulated activities that “may have disseminated false or misleading statements to the investing community, such as representations about the status of FDA review, product approvals, clinical trial results, or other matters within the FDA’s regulatory authority that could affect investors’ decisions.”

That list is worth pausing on: FDA review status, product approvals, clinical trial results. That is the substance of nearly every material press release a clinical-stage or commercial life sciences company issues.

The MOU permits the SEC to use non-public FDA information in two distinct contexts: “to inform any public company filing review to ensure compliance with the federal securities laws and in connection with any enforcement investigation, proceeding, or civil action within the SEC’s jurisdiction.”

The first applies to every public company. Filing review is the routine process by which SEC staff read periodic reports and registration statements and issue comment letters to the companies that file them. The practical change is this: a staff reviewer examining a life sciences company’s disclosure may now have access to FDA information that was previously unavailable to them. Companies should expect questions about FDA-related disclosures to become more specific and require more support than in the past. The second context, enforcement, arises only where the SEC has already opened an investigation or action.

How the Pipeline Works

The MOU is largely administrative plumbing, and the plumbing is what makes it consequential.

The parties also commit to responding to requests “in a timely manner,” and each is directed to consider standing operating procedures and templates to streamline requests for non-public information. The framework is designed to be used.

What the MOU Does Not Do

The agreement carries real limits, and they matter as much as its reach. Trade secrets remain protected: the FDA “will not share trade secret or confidential commercial information with the SEC that is prohibited from disclosure by 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 21 U.S.C. 360ll(d), 21 U.S.C. 360nn(e), or 21 U.S.C. 387f(c), except as allowed by those statutory provisions.”

Information also does not travel beyond the SEC. The SEC “will not disclose non-public information that FDA shares with SEC under this MOU with any person other than an officer, employee, or contractor of the SEC without FDA’s written permission.” Where a third party seeks that information through a FOIA request, subpoena or discovery demand, the receiving agency must notify the originating agency, furnish copies of the demand and cooperate in asserting exemptions and privileges. Sharing under the MOU is not a public disclosure and does not waive confidentiality or any applicable privilege.

The MOU also creates no new legal obligations. It states plainly that it “does not create binding, enforceable obligations against any party,” and that all activity is “subject to the availability of personnel, resources, and funds.” It applies only to requests made after its effective date; it is not to be used “in sharing public information, requesting testimony, or responding to a subpoena for records or testimony,” and either agency may terminate it on 30 days’ notice.

In short, there is no new legal standard here. Securities law already prohibits misleading statements about FDA matters. What the MOU changes is how efficiently a regulator can now compare a company’s disclosure against its regulatory record.

Five Areas Life Sciences Companies Should Review in Light of the SEC-FDA MOU

Come Talk With Us

Disclosure outside the financial statements is drafted in collaboration with the SEC and regulatory counsel, who own that process. The companies that handle this well will be the ones with a disciplined, documented process connecting their regulatory record to their public reporting, established before anyone asks to see it.

If you would like to talk through what this MOU means for your reporting processes, we welcome the conversation. Whether you are evaluating your disclosure controls or looking to strengthen how regulatory information moves through your organization, our team is here to help.

This article is based solely on the Memorandum of Understanding between the U.S. Securities and Exchange Commission and the U.S. Food and Drug Administration, signed August 31, 2026. It is provided for informational purposes and does not constitute legal, accounting or tax advice.