MOU 225-26-009

Memorandum of Understanding
Between the
U.S. Securities and Exchange Commission
And the
U.S. Food and Drug Administration

I. Purpose

The Securities and Exchange Commission (SEC) and the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS), collectively referred to as the parties, intend to facilitate the exchange of information between themselves related to FDA-regulated products and activities. This collaboration aims to enhance both parties’ ability to carry out their respective missions of protecting the public health and ensuring the integrity of the financial markets.

The purpose of this Memorandum of Understanding (MOU) is to establish a framework to support the parties’ respective regulatory and enforcement responsibilities and otherwise enhance cooperation. This is expected to bolster informed decision-making, improve the effectiveness of the parties’ oversight and compliance efforts, and ensure that information relevant to public health and the integrity of financial markets is appropriately shared in accordance with applicable laws and policies.

II. Background

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended (21 U.S.C. 301, et seq.). In fulfilling its responsibilities under the FD&C Act, FDA, among other things, directs its activities toward promoting and protecting the public health by ensuring the safety, efficacy, and security of drugs, biological products, veterinary products, medical devices, and radiological products, and the safety and security of foods and cosmetics. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

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, including broker-dealers, investment companies, investment advisers, clearing agencies, transfer agents, and credit rating agencies, among others. In addition, the SEC is responsible for reviewing the disclosures and financial statements of all public companies in the United States. This includes situations where a firm, including a firm engaged in FDA-regulated activities, 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.

Ill. Substance of the Agreement

1. Each party intends to share appropriate information related to FDA-regulated products and activities, and persons and firms who manufacture, distribute, and sell FDA-regulated products, with the other party, where practicable.
2. Each party will establish a mechanism, such as a mailbox, for receiving requests for information from the other party, and a mechanism to provide non-public information, such as via secure file transfer.
3. The Food and Drug Division of the HHS Office of the General Counsel (also known as the FDA Office of the Chief Counsel or OCC) advises FDA on legal issues relating to this MOU, maintains awareness to identify legal issues, serves as FDA lead for referrals to SEC of potential violations, and serves as FDA lead when an SEC matter is in civil or judicial adjudication.
4. Each party will establish and maintain at least one principal point of contact (POC) from the relevant office or division to facilitate the actions carried out under this MOU and notify the other party of their POCs. Each party will timely inform the other whenever it makes a change to its principal POCs. Additionally, FDA will have at least one POC from its Office of the Chief Counsel, and the SEC will have at least one POC from its Division of Enforcement and at least one POC from its Division of Corporation Finance.
5. This MOU will involve the exchange of information.
   1. When FDA shares information with SEC, this is governed by 21 C.F.R. 20.85. Under that regulation, any FDA record otherwise exempt from public disclosure may be disclosed to the SEC, except that information 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),
      and 21 U.S.C. 387f(c) may only be released as provided by those statutory provisions. Under 21 C.F.R. 20.85, 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. However, as provided by 21 C.F.R. 20.85, the SEC cannot 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.
   2. The SEC’s sharing of information with FDA is governed by 17.C.F.R. 240.24c-1. Under that regulation, the SEC’s non-public information may be provided to FDA upon a showing that such information is needed and provided FDA provides such assurances of confidentiality as the SEC deems appropriate. When the SEC shares information with FDA, it will continue its ongoing practice of obtaining assurances of confidentiality pursuant to customary access requests and grants.
6. For purposes of this MOU, “non-public information” means information that is not generally available to the public and that is provided, received, or otherwise shared between the Parties in connection with this MOU, whether communicated orally, electronically, in writing, or in any other form.
7. The parties will respond to requests for information in a timely manner. Each party will consider establishing and maintaining Standard Operating Procedures (SOP) and templates to facilitate requests for non-public information under this MOU.
8. This MOU is not for use in sharing public information, requesting testimony, or responding to a subpoena for records or testimony.
9. This MOU only applies to requests for information made after the effective date of this MOU. Nothing in this MOU is intended to modify, replace, or otherwise govern the processing of requests that were made prior to the effective date of this MOU. All information sharing remains subject to applicable laws.

IV. Disclosure of Information

1. Except as provided in paragraphs IV. 10-12, access to the shared non-public information shall be restricted to authorized FDA and SEC officials, employees, and contractors who require access to perform their official duties. Such personnel shall be advised of (1) the confidential nature of the information; (2) safeguards against the unauthorized disclosure of confidential information; and (3) the administrative and civil penalties contained in applicable Federal laws for the unauthorized disclosure of confidential information.
2. In sharing with the SEC non-public information that may be exempt from public disclosure, FDA will include a clear statement of this, such as by adding on every page of the information shared: “Official U.S. Food and Drug Administration Documents; Do Not Disclose Without FDA’s Written Permission”.
3. Proper safeguards shall include the adoption of policies and procedures to ensure that the shared non-public information shall be used consistent with applicable laws, including the Trade Secrets Act, 18 U.S.C. 1905; the FD & C Act; and the Privacy Act.
4. 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.
5. If a Freedom of Information Act (FOIA) request is received for any shared non-public information, the receiving party will: (a) if the request implicates documents from the other party in their original form, refer the request to the other party to respond directly to the requester, and notify the FOIA requester of the referral; and (b) if the request implicates documents authored by the receiving party that incorporates non-public information from shared documents, consult with the other party about how to respond to the FOIA request. The receiving party will not indicate to the FOIA requester whether the providing party has responsive or releasable records without the consent of the providing party other than as necessary to satisfy the requirement that it notify the FOIA requester of a referral. All actions taken under this paragraph must be in compliance with 45 C.F.R. 5.25 or 17 C.F.R.
   200.80(c)(3).
6. Requests for information, documents, or data will be sent by secure file transfer, mail, or email. The request should include a description of the requested information and the intended use for it and be signed by an authorized official for the unit in which the information will be used. An SEC request to FDA must include an agreement that the information will not be further disclosed except with FDA’s written permission. The parties may develop model information requests. The parties agree that follow-up questions may be done via telephone conference, with advance notice to be provided to the extent possible. The parties agree to collaborate to resolve issues as promptly as possible.
7. The providing party will include a written transmittal, which may be by email, along with any information shared. The transmittal will indicate whether the information includes non-public information. The parties may develop models for transmitting requested information.
8. The receiving party will direct any requests to further disclose shared non-public information to one or more points of contact of the providing party.
9. Unless prohibited by law, the receiving party will promptly notify one or more points of contact of the providing party of any attempt by a third party to obtain shared non-public information by compulsory process, including a FOIA request, subpoena, discovery request, or litigation complaint or motion, and of any order by a court or administrative body of competent jurisdiction requiring production of shared non-public information and will take the following actions:
   1. furnish to the providing party copies of any such request or order as well as any documents related thereto;
   2. afford the providing party a reasonable opportunity to take whatever action it deems appropriate to preserve, protect, or maintain the confidentiality of non-public information or any privileges associated therewith;
   3. cooperate fully with the providing party to preserve, protect, and maintain the confidentiality of the non-public information and any privileges associated therewith, including asserting any legal exemptions or privileges on the providing party’s behalf that may reasonably be requested to be asserted, including withholding non-public information from disclosure that the providing party has advised is privileged;
   4. to the extent permitted by law and consistent with applicable confidentiality requirements, notify the requester that the non-public information was obtained from the providing party and, where appropriate, advise the requester that requests for such information should be directed to the providing party; and
   5. consent to application by the providing party to intervene in any action in order to preserve, protect, or maintain the confidentiality of the non-public information or any privileges associated therewith.
10. 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. FDA will respond promptly to a request seeking such permission and will give written permission to further disclose when FDA, in consultation with the SEC, determines that such further disclosure is required by law or judicial order.
11. When either party seeks to use shared non-public information in a manner that requires further disclosure, the parties will work together to identify a practical means of facilitating such disclosure, consistent with applicable law and their respective regulatory and enforcement responsibilities.
12. In addition to complying with the notification and permission requirements in paragraphs IV. 8-11 of this MOU, in providing non-public information in response to a request received from a duly authorized Committee of the United States Congress, the receiving party will:
    1. advise the Committee that the non-public information being produced belongs to the providing party; and
    2. use its best efforts to obtain the commitment or agreement of the Committee that it will maintain the confidentiality of the non-public information.
13. The parties intend that sharing non-public information with each other pursuant to the terms of this MOU will not constitute public disclosure, nor will it constitute a waiver of confidentiality or any privilege applicable to such information.

V. General Provisions

1. This MOU shall become effective upon signature of both parties and will continue in effect for a period of three years. This MOU may be extended, modified, or terminated by the parties’ mutual written consent, and may be terminated upon a 30-day advance notice by one party to the other.
2. This MOU represents the broad outline of the parties’ intention to share information to help each other carry out their respective mission and responsibilities. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future understandings or arrangements between the parties and does not affect the ability of the parties to enter into other understandings or arrangements related to this MOU. This MOU does not create binding, enforceable obligations against any party. This MOU and all associated agreements are subject to applicable laws and policies.

VI. Initial Points of Contact for the Parties

1. For SEC
   
   Gabriel Eckstein
   Associate Director
   Division of Corporation Finance, Disclosure Review Program
   EcksteinG@sec.gov
   202-551-3286

   Frank Correll
   Assistant Chief Counsel
   Division of Enforcement, Office of Chief Counsel
   CorrellF@sec.gov
   202-551-4493

2. For FDA
   
   Shannon Singleton
   Deputy Chief Counsel for Litigation
   FDA, Office of the Chief Counsel
   Shannon.Singleton@fda.hhs.gov
   240-778-9481
   
   Elizabeth Miller
   Associate Commissioner
   Office of Inspections and Investigations
   Elizabeth.Miller@fda.hhs.gov
   240-402-7638

VII. Signatures of Responsible Parties

Approved and accepted for U.S. FDA by:

/s/
Kyle Diamantas
Commissioner
Date: August 31, 2026

Approved and accepted for SEC by:

/s/
Paul S. Atkins
Chairman
Date: August 31, 2026