SEC and FDA announce Memorandum of Understanding to support cooperation on market integrity

On August 31, 2026, the United States Securities and Exchange Commission (SEC) and the Food and Drug Administration (FDA) announced a Memorandum of Understanding (MOU) intended to enhance cooperation between the two agencies. The MOU establishes a framework for information sharing and coordination in the agencies’ respective regulatory and enforcement responsibilities, with the stated goals of improving market oversight, bolstering informed decision-making, and ensuring that information relevant to both public health and the integrity of the financial markets is appropriately shared. This alert summarizes the key provisions of the MOU and outlines practical considerations for companies in the life sciences sector.

Background

FDA enforces the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 301 et seq.). Under the FDCA, FDA promotes and protects public health by ensuring the safety, efficacy, and security of drugs, biological products, medical devices, and other FDA-regulated products. FDA does this by reviewing and approving these products before they reach the market, which necessarily entails receiving non-public information from companies seeking approval.

Meanwhile, the SEC’s mission is to protect investors, maintain fair, orderly, and efficient markets, and facilitate capital formation. The SEC oversees the nation’s securities markets and certain primary participants and reviews the disclosures and financial statements of US companies. With respect to FDA-regulated activities, the SEC’s review responsibilities include situations where a firm engaged in FDA-regulated activities has disseminated statements to the investing community, including representations about the status of FDA review, product approvals, clinical trial results, observations following facility inspections, or other matters within the FDA’s regulatory authority that could affect investors’ decisions.

The MOU is not the first instance of SEC interest in FDA-regulated activities or of coordination between the agencies. In 2004, the SEC and FDA announced a formal partnership to enhance cooperation in identifying and investigating securities law violations by public companies. The partnership established a streamlined process for FDA referrals to the SEC, designated contacts within FDA to assist with SEC information requests, and expedited sharing of non-public information between the agencies. FDA has operated under this framework since it was originally announced, with established practices for the exchange of information. This is one of several hundred MOUs between FDA and other agencies.

The SEC’s enforcement record also reflects a focus on potentially misleading FDA-related disclosures and trading on non-public FDA developments. For example, in March 2025, the SEC filed charges against three former Allarity Therapeutics executives, alleging that they concealed negative FDA feedback that the company’s drug would not be approved absent a new drug trial while presenting the existing application as viable; after the company disclosed that FDA refused to review the application, its stock price fell approximately 31 percent, and the company separately consented to a cease-and-desist order and USD2.5 million penalty.

This enforcement action, along with others, reflects the SEC’s continued attention to misleading statements about FDA feedback and clinical developments. The MOU thus formalizes and enhances an existing pattern of interagency coordination, rather than creating a new area of SEC interest.

As SEC Chairman Paul S. Atkins stated, “FDA-related disclosures by public companies have a significant impact on our markets. The FDA is a valuable partner in our efforts to administer and enforce applicable disclosure requirements under the federal securities laws, and I look forward to further strengthening our partnership through the MOU.”

Key provisions of the MOU

The MOU is intended to facilitate the exchange of information between the agencies regarding FDA-regulated products and activities, including information concerning persons and firms that manufacture, distribute, and sell FDA-regulated products. It establishes a framework for cooperation in the agencies’ regulatory and enforcement responsibilities and for sharing information relevant to public health and the integrity of the financial markets in accordance with applicable laws and policies.

The MOU sets out the following framework for information sharing, agency coordination, and the protection and potential use of non-public information:

• Information sharing. The MOU establishes protocols under which each agency intends, where practicable, to share appropriate information related to FDA-regulated products and activities, as well as persons and firms that manufacture, distribute, and sell FDA-regulated products. These include designated mailboxes and secure file transfer for requests and providing non-public information.
  
  
• Points of contact (POCs). Each agency will establish and maintain principal POCs from relevant offices or divisions, notify the other agency of its POCs, and timely inform the other of changes. FDA will have at least one POC from its Office of the Chief Counsel. The SEC will have at least one POC from its Division of Enforcement and at least one from its Division of Corporation Finance.
  
  
• FDA sharing with SEC. The SEC may use non-public information received from FDA 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, but it may not provide any non-public information it receives from FDA to any person who is not an officer, employee, or contractor of the SEC without FDA’s written permission.
  
  
• SEC sharing with FDA. SEC non-public information may be provided to FDA upon a showing that the information is needed and that FDA provides appropriate assurances of confidentiality. When the SEC shares information with FDA, it will continue its practice of obtaining assurances of confidentiality through customary access requests and grants.
  
  
• Freedom of Information Act (FOIA) handling. If a FOIA request implicates documents from the other party in their original form, the receiving party will refer the request to the originating party and notify the requester. If it implicates documents authored by the receiving party that incorporate non-public shared information, the parties will consult on the response.
  
  
• Duration and termination. The MOU becomes effective upon the signature of both parties and continues for three years. It may be extended, modified, or terminated by mutual written consent, and either party may terminate it upon 30 days’ advance notice to the other party.
  
  
• Scope and use limitations. The MOU is not for use in sharing public information, requesting testimony, or responding to a subpoena for records or testimony. The parties may develop model information requests and transmittals, and they agree that follow-up questions may be addressed by telephone conference with advance notice, where possible.

Practical implications

Information sharing by the SEC pursuant to access requests from other agencies is generally routine. Under Section 5.1 of the SEC’s Division of Enforcement Manual, the SEC may grant other governmental authorities, self-regulatory organizations, and other specified persons access to non-public information in its enforcement and regulatory files under Section 24(c) of the Securities Exchange Act of 1934 and Rule 24c-1 thereunder, and the Commission has delegated authority to the Director of Enforcement to grant such requests.

The MOU reflects a coordinated approach between the SEC and FDA, with particular emphasis on companies’ disclosure obligations. In practical terms, the SEC and FDA are positioned to communicate more closely and regularly about whether a company’s statements concerning its drugs or devices are consistent with the generally non-public feedback FDA provides to companies – or, in FDA parlance, “sponsors” – during formal meetings throughout the drug development and review process. The MOU formalizes historic information-sharing practices that have existed between FDA and SEC and may therefore encourage greater coordination and real-time visibility for the SEC regarding industry’s premarket interactions with FDA, enabling it to assess more effectively the accuracy of those companies’ representations to investors and the public.

While the MOU has implications for all companies interacting with FDA (both publicly and privately held), its effects may be more pronounced for pre-commercial, clinical-stage pharmaceutical and biotechnology companies with market values closely tied to the successful development of a particular product, and for which disclosures about the FDA review and approval process may have a greater influence on market participants.

Considerations for companies

The MOU permits the SEC to use non-public FDA information in public-company filing reviews and SEC enforcement matters. Although the MOU does not create binding, enforceable obligations on either agency and remains subject to applicable confidentiality laws and policies, the MOU may have the following implications for life sciences companies:

• Increased SEC scrutiny of FDA-related disclosures. The MOU’s information-sharing framework may enable the SEC to more effectively identify discrepancies between an issuer’s disclosures and non-public FDA information. Life sciences companies may experience heightened scrutiny of statements regarding FDA regulatory submissions, clinical trial results, product approvals, and other FDA-related matters.
  
  
• Enhanced enforcement coordination. The MOU’s establishment of dedicated points of contact within the SEC’s Division of Enforcement and Division of Corporation Finance, as well as FDA’s Office of the Chief Counsel, establishes a more formalized channel for identifying and investigating potential securities law violations involving FDA-regulated products. Companies may wish to note that FDA referrals to the SEC of potential violations may become more routine.

As such, life sciences and related companies may wish to consider:

• Review of disclosure practices. Companies in the life sciences sector may wish to review their disclosure controls and procedures to ensure that FDA-related disclosures – including statements about the status of FDA review, product approvals, clinical trial results, and other matters within the FDA’s regulatory authority – are accurate, complete, and not misleading. Companies are encouraged to ensure that individuals responsible for FDA-related disclosures are aware of the MOU and the potential for heightened regulatory scrutiny.
  
  
• Insider trading implications. The MOU’s information-sharing protocols may increase the speed and frequency with which non-public FDA information reaches the SEC. Companies may wish to review their insider trading policies and compliance programs to ensure that material non-public information related to FDA regulatory matters is properly addressed.
  
  
• Coordination with legal and regulatory teams. Companies may wish to ensure coordination between their securities counsel and FDA regulatory counsel when preparing public disclosures involving FDA-regulated products or activities.
  
  
• Monitoring implementation. Companies may wish to monitor how the agencies implement the framework and how it may affect future interactions involving FDA-regulated products or activities.

Learn more

DLA Piper will continue to monitor these developments. For more information, please contact the authors or your DLA Piper relationship attorney.