SEC and FDA Formalize Information-Sharing Framework for Public Companies

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 formal framework for the two agencies to share non-public information concerning FDA-regulated products and the companies and individuals engaged in their manufacture, distribution, and sale. The MOU was signed by SEC Chairman Paul S. Atkins and Acting FDA Commissioner Kyle Diamantas. It takes immediate effect and runs for three years, subject to renewal, modification, or termination. In a press release, Chairman Atkins described FDA-related disclosures by public companies as having “a significant impact on our markets” and identified the FDA as “a valuable partner in our efforts to administer and enforce applicable disclosure requirements under the federal securities laws.” Acting Commissioner Diamantas framed the MOU as protecting “both the patients who rely on FDA-regulated products, and the public trust that drives health care innovation.”

Since July 2025, the FDA has pursued what it has called a “radical transparency” agenda, publishing more than 200 previously non-public Complete Response Letters (CRL). In September 2025, the agency announced that it would release future CRLs in real time. That initiative identified a specific concern: that sponsors were not providing investors and shareholders with complete and contextualized information about CRL content and the regulatory status of their applications. The MOU formalizes the SEC’s intent to have a direct, structured channel to obtain FDA records that bear on public company disclosures.

Publicly-traded hospitals and health systems, particularly those that participate in clinical trials, may encounter indirect regulatory exposure under the MOU. In addition, physicians associated with issuers who make public statements about an FDA-regulated clinical trial may face scrutiny if the FDA determines such statements could mislead investors. Publicly-traded health plans might also be indirectly impacted if they make claims about the safety or efficacy of an FDA-regulated product that is not consistent with shared non-public FDA information.

Overview: What the MOU Does

• Scope and information flow. The MOU establishes a framework for the FDA and SEC to share non-public information related to FDA-regulated products and activities, and companies associated with such products. While the MOU contemplates reciprocal information sharing, the operative direction is from FDA to SEC. The background section of the MOU calls out potential misstatement by issuers about FDA-domain matters as the primary concern driving its creation.
• Permitted uses. Non-public FDA information obtained by the SEC under the MOU may be used to inform the SEC’s review of public company filings and in connection with SEC enforcement investigations, proceedings, and civil actions. The SEC’s Division of Corporation Finance’s Disclosure Review Program and the Division of Enforcement will each have a point of contact under the MOU. The reference to both divisions means that the MOU is designed to serve both routine filing review and potential enforcement functions simultaneously.
• FDA points of contact. On the FDA side, the Office of Chief Counsel and the Office of Inspections and Investigations serve as the designated points of contact. Notably, the FDA’s Office of Chief Counsel is described as the lead for referrals to the SEC of potential securities violations.
• Confidentiality and non-redisclosure. Non-public information is intended to stay non-public, as the SEC should only disclose the information to SEC personnel and contractors; however, the FDA can provide written permission to the SEC to disclose information to third parties, creating a potential for disclosure of non-public information outside the SEC, possibly as part of SEC enforcement investigations. The MOU establishes a compulsory process playbook: if a third party seeks shared non-public information through a Freedom of Information Act (FOIA) request, subpoena, discovery request, or litigation motion, the receiving agency must promptly notify the providing agency and cooperate to protect confidentiality, including allowing the providing agency to intervene. The MOU’s confidentiality obligations may have implications for individuals or companies entering the Wells Process where the SEC holds non-public FDA information that does not align with the recipient’s account of events. The MOU does not address investigative scenarios – prior to an enforcement action being filed – where the SEC may have FDA confidential information pursuant to the MOU that does not align with an individual’s or issuer’s view of events.¹ Thus, defense counsel may wish to engage with the SEC early in the Wells Process on these issues.

Implications for Health Care Companies

• Public company disclosure of FDA interactions. The MOU’s primary practical effect is to create increased scrutiny by the SEC around issuer disclosures regarding FDA interactions. Companies routinely describe the content and outcome of FDA meetings, the characterization of CRLs, the status of pending applications, and the progress of clinical trials in their SEC filings, press releases, and earnings calls. Those characterizations are now subject to potential cross-verification against FDA meeting minutes, correspondence, and internal records that the SEC can formally request. All filings should be reviewed for consistency and accuracy with FDA interactions, and companies should consider revising operations and practices around filings, including adding an additional legal review to ensure alignment.
• Complete Response Letters. The FDA’s real-time CRL publication initiative means that CRL content is increasingly public. The MOU adds a further layer: even where a CRL has not yet been publicly released, the SEC can now formally request it from the FDA. Companies that have characterized CRL content in investor-facing materials, including in response to analyst questions on earnings calls, should consider whether those characterizations are consistent with the CRL’s actual content.
• Emerging and pre-commercial companies. Although the MOU is explicitly directed at public companies, its practical implications extend to companies preparing for an initial public offering (IPO). Representations about FDA interactions in registration statements, IPO roadshow materials, and analyst day presentations are subject to the same disclosure standards as post-IPO filings.
• The FDA referral function. The identification of the FDA’s Office of Chief Counsel as the lead for referrals to the SEC of potential securities violations is a structural feature of the MOU that warrants attention. It means that the FDA has a formalized mechanism to flag disclosure concerns to the SEC as part of its ordinary regulatory interactions with companies. Sponsors engaged in active FDA regulatory proceedings should be aware that those interactions now occur in a context where the FDA’s own counsel may identify and refer potential securities law issues.
• Insider trading considerations. Given the likelihood that the SEC will receive information from the FDA on a more real-time basis, without having to go to issuers directly, this may increase SEC enforcement investigations into who had access to material non-public information and whether they traded on such information.

What We Are Watching

The MOU is effective immediately, but its operational implementation is not yet crystallized. We are monitoring the following developments:

• Whether the SEC and FDA publish or standardize the operating procedures and templates for information requests and transmittals that the MOU contemplates, and what those procedures reveal about the volume and categories of information that may be shared.
• Patterns in SEC Division of Corporation Finance comment letters that suggest FDA-provided non-public information is informing filing review.
• Early enforcement matters in which parallel SEC and FDA activity suggests coordination under the MOU framework, even where neither agency publicly attributes the matter to the MOU.
• Any FOIA litigation or compulsory process disputes arising from the MOU’s non-redisclosure and referral provisions, which may clarify the scope of confidentiality protections for shared information.
• Renewal, modification, or termination activity at the three-year mark (August 2029), and any interim policy statements from either agency about the MOU’s operation.

What Companies Should Do

• Audit existing disclosures. Companies may wish to conduct a comprehensive review of recent SEC filings, press releases, earnings call transcripts, and investor presentations that may have had material impacts on share prices for characterizations of FDA interactions, including descriptions of FDA meetings, application status, clinical trial results, and CRL content, and confirm that those characterizations are consistent with the underlying FDA records.
• Implement enhanced review processes. Companies should consider adding a dedicated legal review layer focused specifically on ensuring alignment between FDA-facing communications and investor-facing disclosures. Regulatory counsel, securities counsel, and potentially disclosure committees, should coordinate on determining whether any public disclosure is required and assessing the accuracy of any public statement that characterizes the substance or outcome of FDA interactions.
• Reassess CRL disclosure practices. Given the FDA’s real-time CRL publication initiative and the SEC’s ability under the MOU to formally request unpublished CRLs, companies should ensure that any investor-facing characterizations of CRL content, including responses to analyst questions on earnings calls, are accurate, complete, and consistent with the CRL’s actual content.
• Prepare for heightened scrutiny in the IPO context. Companies preparing for an IPO should apply the same rigor to representations about FDA interactions in registration statements, roadshow materials, and analyst day presentations, as those disclosures are subject to the same standards as post-IPO filings.
• Evaluate internal coordination frameworks. Given the FDA’s formalized referral function under the MOU, companies should ensure that regulatory affairs teams and securities counsel are coordinating on disclosure matters and that those interactions are structured to identify potential securities law implications before public statements are made.
• Review policies, procedures, and training. In light of the MOU, issuers and other companies operating in the space should consider whether to enhance insider trading policies, training, and compliance, including as it relates to third parties with access to non-public FDA-domain information.

Crowell & Moring will continue to monitor developments related to the MOU’s implementation and the evolving interagency coordination framework. Please reach out to the authors if you would like assistance reviewing your disclosure practices or evaluating the impact of this new framework on your organization.