MOU 225-26-007

MEMORANDUM OF UNDERSTANDING BETWEEN THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION AND THE U.S. DEPARTMENT OF VETERANS AFFAIRS

I. PURPOSE

This Memorandum of Understanding ("MOU") between the U.S. Department of Health and Human Services (HHS), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Veterans Affairs (VA) (hereafter “the Parties” or “Federal Partners”) provides a framework for collaboration and the exchange of information to accelerate action on treatments for substance use disorder and mental health conditions. This MOU aligns with and promotes the April 2026 Executive Order (EO), “Accelerating Medical Treatment for Serious Mental Illness,” as well as the January 2026 EO, “Addressing Addiction Through the Great American Recovery Initiative.”

II. BACKGROUND

The mission of HHS is to enhance the health and well-being of all Americans, by providing effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. FDA is a science-based regulatory agency within HHS that is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the FDCA), as amended (21 U.S.C. § 301, et seq.). In fulfilling its responsibilities under the FDCA, FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products, and the safety and security of foods, dietary supplements, 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. FDA enters into this MOU pursuant to section 1003(b) and (c) of the FDCA (21 U.S.C. § 393(b) and (c)).

The mission of VA is to fulfill President Lincoln’s promise “to care for him who shall have borne the battle, and for his widow, and his orphan” through the efficient delivery of health care and other benefits and services to the men and women who are America’s Veterans and their families. VA operates the largest integrated healthcare system in the United States, with over 1,200 points of care delivery reaching into nearly every community in the Nation. In addition to its Veteran-centric missions involving care, research and education, VA has been called to action for all Americans in response to national emergencies and medical crises. VA enters into this MOU pursuant to 38 U.S.C. §§ 513, 7301, and 7303.

Through their roles in the executive branch of the federal government, HHS/FDA and VA both work to improve the health of Americans. Each agency has this common goal but operates under different statutory mandates and responsibilities.

This MOU to facilitate collaboration and the sharing of information in a timely and efficient manner advances the Federal Partners’ mission to work to improve the health of all Americans, including America’s Veterans.

Together, the two EOs highlight the need to collaborate on areas such as clinical trial participation, data sharing, and generation of real-world evidence to address substance use disorder and mental health conditions.

III. SUBSTANCE OF UNDERSTANDING

The Parties intend to coordinate, as appropriate and consistent with applicable law, to support timely information sharing related to substance use disorder and mental health conditions. This may include identifying relevant information needs, sharing available data, analyses, or methods, and supporting each Party’s respective mission, authorities, and responsibilities.

Types of data shared under this MOU may include but are not limited to clinical trial data, safety information, and real-world data. Data shared under this MOU may be used to:

1. Provide operational decision support for public health, patient care, and health care quality improvement programs;
2. Assist in the surveillance, analysis, prediction, and response to existing and emerging public health concerns; and
3. Assist in the review of medical treatments for substance use disorder and mental health conditions, including potential treatments addressed in the two EOs (e.g., psychedelic drugs), as appropriate and consistent with applicable law.

This MOU establishes a framework for collaboration and information exchange and does not independently authorize the disclosure of any VA or FDA records or information. Any disclosure under or in connection with this MOU must be independently authorized by applicable law, regulation, and policy. The Sharing Party retains responsibility for determining whether a proposed disclosure is permitted.

IV. ROLES AND RESPONSIBILITIES

It is mutually agreed, consistent with their respective authorities, that the Federal Partners will:

1. Participate in periodic joint meetings to promote better communication and understanding of regulations, policies, and statutory responsibilities relevant to the purpose of this MOU.
2. Notify the other Party as soon as possible when issues of mutual concern become evident.
3. Provide technical advice, as appropriate, in areas of recognized expertise.
4. Facilitate information/data exchange, including by planning and implementing joint data-sharing initiatives, subject to the limitations and process set forth in sections VIII and IX.

V. GENERAL PROVISIONS

Resource obligations. This MOU represents the broad outline of the Parties intent to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds. This MOU does not create binding, enforceable obligations against any Party. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU.

Press Releases and Public Communications. To the extent practicable and consistent with applicable law, the Parties shall, when appropriate, notify and consult with the other Party before issuing any press release, publication, public announcement, or other communication that references this MOU, the other Party, or joint activities under this MOU. The Parties will coordinate in good faith regarding timing, content, and attribution.

VI. EFFECTIVE DATE, DURATION, TERMINATION, AND REVIEW

This MOU becomes effective upon the signature of authorized representatives of all Parties and remains in effect for a period of five [5] years. This MOU may be modified by mutual written consent or terminated by any Party upon 60 days written notice. This MOU may be terminated by any Party immediately upon written notice in the event that a Federal statute is enacted, or a regulation is issued by any Party that materially affects this MOU. The Parties may consider the development of a new MOU as needed.

VII. POINTS OF CONTACT/LIAISONS

The Parties will designate Points of Contact/Liaisons to facilitate communication and address collaborative matters as they arise. It is incumbent upon the Parties to update these Points of Contacts/Liaisons as needed and notify their respective administrative units of such updates.

VIII. EXCHANGES OF NON-PUBLIC INFORMATION

Both Parties recognize and acknowledge that it is essential that any non-public information shared between or within the Parties, whether in writing or orally, may not be further used or disclosed unless authorized by law and consistent with the terms under which the information was shared. No information shall be shared under this MOU unless the Sharing Party determines that the sharing is permitted by applicable law, regulation, and policy. See e.g., 38 U.S.C. §§ 5701, 7332; 21 U.S.C. § 331(j); 18 U.S.C. § 1905; 5 U.S.C. 552; 5 U.S.C. § 552a; 21 C.F.R. Parts 20 and 21; 38 C.F.R. § 1.488; 45 C.F.R. Parts 5, 5b, 160, and 164; and 42 U.S.C. § 241(d). Safeguards are important to protect the interests of, among others, owners and submitters of trade secrets and confidential commercial information personal privacy information; privileged and/or pre-decisional agency records; and information protected for national security reasons. Such safeguards also help ensure the Parties’ compliance with applicable laws, regulations, and policies. The sharing of identifiable patient information and national security information is not contemplated by this MOU.  

To the extent that any confidential or other non-public information will be shared pursuant to this MOU, the following provisions apply:

1. Access to the confidential and non-public information shared under this MOU shall be restricted to authorized HHS/FDA and VA employees, agents, and officials who require access to perform their official duties in accordance with the uses of the information as authorized in this MOU and any such non-public information is shared by FDA pursuant to 21 C.F.R. 20.85. 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. Proper safeguards shall include the adoption of policies and procedures to ensure that the information shared under this MOU shall be used consistent with the Trade Secrets Act [18 U.S.C. § 1905], the FDCA [21 U.S.C. 301 et seq.], the Privacy Act of 1974, as amended [5 U.S.C. § 552a], the Freedom of Information Act (FOIA) [5 U.S.C. § 552], Confidential Nature of Claims [38 U.S.C. § 5701], Confidentiality of Certain Medical Records [38 U.S.C. § 7332], or any other applicable Federal laws and their implementing regulations. Pursuant to FDCA section 301(j) [21 U.S.C. § 331(j)], FDA will not reveal to VA any method or process which is entitled to protection as a trade secret.

IX. INFORMATION SHARING PROCESSES FOR NON-PUBLIC INFORMATION

To facilitate the sharing of non-public information between the Parties, both Parties are committed to responding to requests for information in a timely manner, consistent with budgetary and resource constraints, and in accordance with applicable laws, regulations, and agency policies and practices. Provisions for the sharing of non-public information, both written and oral, are set out below.

1. The Requesting Party must specify, in writing, which may include informal written communication, e.g., email, the information requested and a brief statement of why the information is being requested and which unit offices and/or employees will have access to the information. This written communication should include the following template language: ‘This request is made pursuant to MOU No. __, between FDA/[FDA component] and VA/[VA component].” Requests made by HHS/FDA to VA under this MOU for data potentially supporting FDA review of safety and efficacy of a drug (e.g., clinical trial data) shall reference “Executive Order—Accelerating Medical Treatments for Serious Mental Illness” or “Executive Order—Addressing Addiction Through the Great American Recovery Initiative” to facilitate rapid processing.
2. Before disclosing any non-public information, the Sharing Party will determine and document the legal authority permitting the disclosure, the category of information to be disclosed, the authorized purpose of the disclosure, any applicable limitations on use or redisclosure, and any required safeguards. The Requesting Party will provide sufficient information to enable the Sharing Party to make this determination, including the information requested, the purpose and intended use, the offices or personnel requiring access, and any anticipated onward use or disclosure. When acting as a Sharing Party, VA and FDA will follow their respective procedures for documentation prior to disclosure.
3. The Requesting Party will limit the dissemination of shared non-public information it receives to internal unit offices and/or employees that have been identified in its written request. If the Requesting Party determines that employees other than those identified in the original request have a need to know the requested information, then an update to the request letter will be supplied.
4. Before receiving any non-public information from the Sharing Party, the Requesting Party will agree in writing, by using the model request letter in Appendix A (or a reasonable, mutually agreed upon variation), indicating that these activities are authorized by law, that the records or information will be used only for the stated purpose and will not be disclosed further without the prior written permission of the Sharing Party, including disclosure in publications and public meetings. If the Requesting Party wishes to disclose shared information that the Sharing Party has designated as non-public, the Requesting Party will ask the Sharing Party whether the information’s non-public status has changed, and if so, will first obtain written confirmation and permission from the Sharing Party before disclosing that information.
5. If a FOIA request is received for any shared information, the Requesting Party will: (a) if the request implicates documents from the Sharing Party in their original form, refer the request to the Sharing Party for that Party to respond directly to the requester, and notify the FOIA requester of the referral and that a response will issue directly from the Sharing Party regarding the releasability of the information; and (b) if the request implicates documents authored by the Requesting Party that incorporate information from shared documents, consult with the Sharing Party about how to respond to the FOIA request. The Requesting Party will not indicate to the FOIA requester whether the Sharing Party has responsive or releasable records. All actions taken under this paragraph must be in compliance with 45 C.F.R. 5.25 and 38 C.F.R. § 1.555, as applicable.
6. The Sharing Party will include a transmittal letter along with any agency information shared. The transmittal letter will indicate the type of information (e.g., confidential commercial information, personal privacy, pre-decisional, etc.). A model transmittal letter is in Appendix B. The shared documents containing non-public information should be stamped “Do not disclose without permission of [FDA or VA].”
7. The Requesting Party will promptly notify the contact person or designee of the Sharing Party of any attempt by a third party including requests by Congress, the Office of Inspector General, or the Government Accountability Office, to obtain shared non-public information by processes, including, but not limited to a voluntary request, subpoena, discovery request, or litigation complaint or motion. The Parties shall consult before complying with any request to obtain shared non-public information, so that the Parties may determine the appropriate measures to take, including, where appropriate, legal action.

X. SIGNATORIES AND PARTICIPATING PARTIES

Approved and Accepted for the Food and Drug Administration

Kyle A. Diamantas, J.D.
Acting Commissioner of Food and Drugs
Date: July 13, 2026

Approved and Accepted for the Department of Veterans Affairs

John Figueroa
Acting Under Secretary for Health
Date: July 13, 2026

APPENDICES

Appendix A: Model Request Letter
Appendix B: Model Transmittal Letter

Appendix A
Model Request Letter

This request is made pursuant to MOU No. __, between FDA and VA. [Requesting Party/Office] requests access to the following non-public information: [Request: list the type of records/information requested, including any firm and/or product names and the relevant timeframe] [for VA only: pursuant to 21 C.F.R. § 20.85].
The purpose for which the information is requested is to assist in the [state the nature of your interest]. The records will only be used by [insert Agency components] for the following authorized activity: [state the activity]. 
I certify that these activities are authorized by law, that the records or information will be used only for the stated purpose and will not be disclosed outside [Requesting Party/Office] without the prior written permission of the [Sharing Party]. I also certify that sharing within [Requesting Party/Office] will be limited to the specific purpose stated above, and that I will provide a copy of this letter and the transmittal letter to any person(s) with whom I share the non-public information. 
[For VA requests only: I understand that section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 331) prohibits disclosure of trade secret information outside the Department of Health and Human Services.] 

Sincerely, 
YOUR SIGNATURE LINE 
[Contact Information]

 
Appendix B
Model Transmittal Letter

MOU No. ____________

This letter accompanies agency records that the [Sharing Party] is sharing with the [Requesting Party] in response to [Requesting Party’s] request, dated __________. These agency records contain one or more of the following categories of non-public information, the public disclosure or further use of which may be restricted or prohibited by law. The Sharing Party has determined that the disclosure to [Requesting Party] is permitted by applicable law, regulation, and policy, subject to the limitations identified in this transmittal letter and the request letter dated __________.

[Sharing Party] checks applicable items below:

1. non-public information belonging to a third party/entities other than [Sharing Party], including:
[VA Only: ___    Trade secrets;]
___    Confidential commercial or financial information;
___    Information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy;
___    Other: _________.

2. non-public information belonging to [Sharing Party] including:
___    Intra-agency records
___    Records or information compiled for law enforcement purposes 
___    Other: 

[Requesting Party] shall notify the appropriate office of [Sharing Party] if there are any attempts by third parties, including Congress, the Office of the Inspector General, or the Government Accountability Office, to obtain shared information, including but not limited to Freedom of Information Act requests, subpoenas, discovery requests, and litigation complaints or motions. 
[Requesting Party] shall notify the [Sharing Party] before complying with any judicial order that compels the release of such information that FDA and VA may take appropriate measures, including filing a motion with the court or an appeal.

[FDA/VA] has agreed, by this letter or e-mail and by a signed request letter dated ____________, not to publicly disclose the above-described information without prior written permission of [FDA/VA]. [FDA/VA] acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See, e.g., 5 U.S.C. § 552a; 38 U.S.C. §§ 5701, 7332; 21 U.S.C. § 331(j); 18 U.S.C. § 1905, 21 C.F.R. Parts 20 and 21, 45 C.F.R. Parts 5, 5b, 160 and 164, and 42 U.S.C. § 241(d).
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