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  1. FDA Memoranda of Understanding

MOU 225-16-012

MOU 225-16-012

MEMORANDUM OF UNDERSTANDING
BETWEEN THE FOOD AND DRUG ADMINISTRATION,
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND THE U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT
 
 
I. Purpose
 
The purpose of this Memorandum of Understanding (MOU) is to establish a framework for enhanced cooperative efforts, including information-sharing efforts, between the Agency for International Development (USAID) and the Food and Drug Administration, U.S. Department of Health and Human Services (FDA) (together, the Participants) to ensure the safety, efficacy, and quality of medical products regulated by FDA and procured by USAID in the context of the U.S. President's Emergency Plan for AIDS Relief (PEPFAR).
 
II. Background
 
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. § 301 et seq.). In fulfilling its responsibilities under the Act, FDA directs its activities toward, among other things, promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, and medical devices; and the safety and security of foods, dietary supplements, cosmetics, and radiological products. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products.
 
FDA ensures the availability of safe, effective, and quality antiretroviral drugs to meet the in-country treatment goals of global agencies and governments engaged in the treatment and care of patients living with HIV/AIDS. Using a process that combines focused engagement with companies prior to submitting authorization packages and the “expedited review” determination, FDA approves or tentatively approves single-entity, fixed-dose combination, and co-packaged versions of previously-approved antiretrovirals (most of which are still protected in the United States by patent and/or exclusivity) to increase the arsenal of low-cost, high-quality HIV/AIDS therapies available for purchase under PEPFAR. By making these much-needed, high-quality generic products available for registration and marketing in PEPFAR focus countries, FDA has significantly reduced the cost of treatment and helped save lives.
 
USAID is the lead U.S. Government agency that works to end extreme global poverty and enable resilient, democratic societies to realize their potential while advancing U.S. security and prosperity. As a development agency, USAID has focused for many years on strengthening primary health care systems in order to prevent, and more recently to treat and care for, a number of communicable diseases, including HIV/AIDS.
 
Under PEPFAR, USAID works with governments, non-governmental organizations, and the private sector in order to provide training, technical assistance, and medical products (including pharmaceuticals) to prevent and reduce the transmission of HIV/AIDS and to provide treatment and care to people living with HIV/AIDS. USAID supports targeted research, development, and dissemination of new technologies, as well as packaging and distribution mechanisms for antiretrovirals through the Supply Chain Management System. USAID may only procure antiretrovirals that have been approved by a stringent regulatory authority, such as FDA. 
 
FDA occasionally has the need to share certain non-public information acquired during its regulatory activities with USAID, whether proactively or in response to a request from USAID. Millions of patients in PEPFAR programs rely primarily on FDA-approved HIV/AIDS medicines procured by USAID. Therefore, any FDA regulatory actions relating to PEPFAR medical products that result in disruption in the manufacturing of antiretrovirals may cause drug shortages for PEPFAR programs globally. FDA’s informing USAID of regulatory actions ahead of time may help prevent drug shortages by allowing USAID lead time to align procurement mechanisms or put into place appropriate quality measurements for antiretrovirals for which there are no alternative manufacturers or for which other manufacturers lack capacity to meet the clinical demand. There can also be occasions on which FDA’s providing non-public information to USAID in response to a request from USAID supports the efficient procurement of safe, effective, and quality medical products for PEPFAR.
 
III.  General Provisions
 
A. This is an internal U.S. government MOU between FDA and USAID and does not confer any rights or benefits to any person or either Participant.
B. This MOU represents the Participants’ present intent to collaborate in cooperative efforts to ensure the safety, efficacy, and quality of medical products regulated by FDA and procured by USAID in the context of PEPFAR.
C. All activities undertaken under this MOU are subject to the availability of personnel, resources, and funds.
D. This MOU does not affect or supersede any existing or future agreements or arrangements between the Participants.
E. This MOU does not create binding, enforceable obligations against any person or either Participant.
F. This MOU is subject to the applicable policies, rules, regulations, and statutes under which FDA or USAID operates.
 
IV. Sharing Non-Public Information
 
A. The sharing of non-public information will be in accordance with applicable statutes and regulations.
 
B. FDA is authorized under 21 C.F.R. 20.85 to disclose certain non-public information to USAID regarding FDA-regulated products in reliance on the Confidentiality Agreement signed by USAID on April 12, 2016 (Appendix 1).
 
C. FDA may share such non-public information with USAID proactively, or USAID may request non-public information from FDA.
 
D. USAID recognizes that FDA may, in light of FDA’s practices, priorities, and resources, decide not to provide non-public information to USAID in response to a request from USAID.
 
E. Pursuant to 21 U.S.C § 331(j), FDA will not reveal to USAIDany method or process which is entitled to protection as a trade secret without the written consent of the person with the authority to provide such consent. Furthermore, pursuant to 21 U.S.C. § 360j(c), FDA will not reveal to USAID certain confidential commercial information relating to medical devices.
 
F. USAID recognizes that information exchanged that contains any of the following types of information should be protected from unauthorized use and disclosure: (1) confidential commercial information, such as the information that would be protected from public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA); (2) personal privacy information, such as the information that would be protected from public disclosure pursuant to Exemption 6 or 7(C) of the FOIA; (3) information compiled for law enforcement purposes and information concerning internal government deliberations that would not be disclosed to the public by FDA, or (4) information that is otherwise protected from public disclosure by federal statutes and their implementing regulations (e.g., Trade Secrets Act (18 U.S.C. § 1905)), the Privacy Act (5 U.S.C. § 552a), other FOIA exemptions not mentioned above (5 U.S.C. § 552(b)), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), and the Health Insurance Portability and Accountability Act (Pub. L. 104-191). 
 
G. FDA intends to include a transmittal letter with any non-public information shared. A model transmittal letter is attached to this MOU (Appendix 2). In addition, each page of the shared documents containing non-public information should be stamped “Do not disclose without permission of FDA.” If the information is shared orally, by telephone or in meetings, FDA expects to begin discussions with a reminder that the information is confidential and covered by the non-disclosure agreement, with words substantially to the effect of the following: “FDA is sharing this information with USAID in reliance on the [April XX, 2016] Statement of Legal Authority and Commitment from the U.S. Agency for International Development Not to Publicly Disclose Non-Public Information Shared by the Food and Drug Administration, U.S. Department of Health and Human Services.”
 
H. USAID intends to establish proper internal safeguards to ensure that information shared under this MOU be used and disclosed solely in accordance with applicable laws and regulations. Access to the information shared under this MOU should be restricted to authorized USAID employees, agents, and officials who require access to perform their official duties. At the time access is granted, such personnel should be advised of the (1) confidential nature of the information; (2) safeguards required to protect the information; and (3) administrative, civil, and criminal penalties for noncompliance contained in applicable Federal laws. Contractors, their subcontractors, and agents requiring access to the information shared under this MOU should be required to sign a business associate agreement by which they will commit to keep the information confidential.
 
I. USAID should not disclose any shared non-public information in any manner not authorized by law or regulation, including disclosure in publications and public meetings. If USAID wishes to disclose shared information that FDA has designated as non-public, USAID should obtain written permission from FDA before disclosing that information.
 
J. USAID should promptly notify FDA of any attempt by a third party to obtain shared non-public information by compulsory process, including, but not limited to, a FOIA request, subpoena, or litigation discovery request.
 
K. If USAID receives a FOIA request for shared information, USAID should refer the FOIA request to FDA.
 
L. USAID should notify FDA before complying with any judicial order that compels the release of shared non-public information, so that the FDA may determine the appropriate measures to take, including, where appropriate, taking legal action.
 
V.  Liaisons
 
A. For FDA:
 
FDA PEPFAR Liaison
Office of International Programs
 
B. For USAID:
 
Christine Malati, PharmD
USAID/GH/OHA/SCH
Contracting Officer's Representative (COR), Global Health Supply Chain-Quality Assurance
517-228-4780
 
John Crowley, PhD
USAID/.GH/OHS/SCH, Division Chief
571-551-7215
 
Joel Kuritsky, MD
USAID/GH/OHS/SCH, Medical Advisor
COR, Global Health Supply Chain-Rapid Test Kits
571-55-7231
 
Each Party may designate new liaisons at any time by notifying the other Party's administrative liaison in writing.
 
VI. Modification and Termination
 
The Participants intend that this MOU become effective when accepted by both Participants. The Participants understand that this MOU may be modified or terminated by mutual written consent, or it may be terminated by either Participant upon 60 days’ advance written notice to the other.
 
APPROVED AND ACCEPTED FOR THE AGENCY FOR INTERNATIONAL DEVELOPMENT
 
David Stanton, M.N., M.P.H.
Director
Office of HIV/AIDS
 
April 12, 2016
 
APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
 
Mary Lou Valdez, MSM
Associate Commissioner for International Programs
Office of the Commissioner
 
April 12, 2016
  
Appendix 1 – Confidentiality Agreement
 
Statement of Legal Authority and Commitment from the U.S. Agency for International Development
Not to Publicly Disclose Non-Public Information Shared by the Food and Drug Administration,
U.S. Department of Health and Human Services
 
This is a Confidentiality Agreement between the U.S. Agency for International Development (USAID) and the Food and Drug Administration, U.S. Department of Health and Human Services (FDA), signed in conjunction with the April 12, 2016 Memorandum of Understanding between the U.S. Agency for International Development and the Food and Drug Administration, U.S. Department of Health and Human Services (MOU). Under 21 C.F.R. § 20.85, and pursuant to such a written Confidentiality Agreement, FDA is authorized to disclose certain non-public information to USAID regarding FDA-regulated products in the context of the U.S. President's Emergency Plan for AIDS Relief (PEPFAR).
 
USAID understands that some of the information it receives from FDA may include non-public information exempt from public disclosure under the laws and regulations of the United States, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information. USAID understands that this non-public information is shared in confidence, and that FDA considers it critical that USAID maintain the confidentiality of the information. Public disclosure of this information by USAID could seriously jeopardize any further regulatory interactions between FDA and USAID. FDA will advise USAID of the non-public status of shared information at the time that the information is shared, in accordance with Section IV.E of the MOU.
 
Therefore, USAID certifies that it:
 
1. has the authority to protect the non-public information provided to USAID in confidence by the FDA from public disclosure;
  
2. will not publicly disclose the FDA-provided non-public information without the written permission of FDA;
 
3. will inform FDA promptly of any effort made to obtain FDA-provided non-public information from USAID by judicial or legislative mandate. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, USAID will take all measures in an effort to ensure that the information will be disclosed in a manner that protects the information from public disclosure; and
 
4. will promptly inform FDA of any changes to U.S. law or USAID policies or procedures that would affect USAID’s ability to honor the commitments in this Confidentiality Agreement.
 
[USAID’s signature block]
Appendix 2 – Model Transmittal Letter
 
TRANSMITTAL LETTER/E-MAIL
 
From: [Name of FDA transmitting official]                            Date: 
 
MOU Control No.: 
 
The U.S. Food and Drug Administration, U.S. Department of Health and Human Services (FDA) is sharing the accompanying agency records with the U.S. Agency for International Development (USAID) pursuant to the April 12, 2016 Memorandum of Understanding between the U.S. Agency for International Development and the Food and Drug Administration, U.S. Department of Health and Human Services (MOU).
 
These agency records may contain one or more types of non-public information, including information the public disclosure of which may be prohibited by law.
 
FDA is sharing this information with USAID in reliance on the April 12, 2016 Statement of Legal Authority and Commitment from the U.S. Agency for International Development Not to Publicly Disclose Non-Public Information Shared by the Food and Drug Administration, U.S. Department of Health and Human Services (Appendix 1 of the MOU), and with the understanding that:
 
· USAID will notify FDA if there are any attempts to obtain information received from FDA by compulsory process, including, but not limited to, Freedom of Information Act requests, subpoenas, and litigation discovery requests;
 
· USAID will notify FDA before complying with any judicial order that compels the release of such information, so that FDA may take appropriate measures, which may include filing a motion with the court or an appeal;
 
· USAID will not disclose the above-described information without prior written permission of FDA; and
 
· USAID acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See, e.g., 21 U.S.C. § 331(j); 18 U.S.C. § 1095; 21 C.F.R. Parts 20 and 21; 45 CF.R. Parts 5 and 5b; and 42 U.S.C. § 241(d).
 
Questions regarding the non-public status of the attached information should be directed to: [FDA office sharing the information].

1. References to USAID may be replaced with references to an appropriate sub-unit of USAID.

USAID designated new liaisons or updated its liaison positions on February 12, 2019. The modifications include the following:
 
a. Removal of liaisons:
i. John Crowley 
ii. Joel Kuritsky
 
b. New liaisons:
James Maloney
USAID/GH/OHA/SCH, Division Chief
jmaloney@usaid.gov
 
Sherif Mowafy
USAID/GH/OHA/SCH, Management Branch Chief
smowafy@usaid.gov
 
Xavier Tomsej
USAID/GH/OHA/SCH, Contracting Officer's Representative (COR) for Global Health Supply Chain 
-Procurement Supply Management (GHSC-PSM), 
xtomsej@usaid.gov
 
Dianna Edgil, PhD
USAID/GH/OHA/SCH, Technical Branch Chief
dedgil@usaid.gov
 
Messai Belayneh, PharmD, Pharmacist
USAID/GH/OHA/SCH 
mebelayneh@usaid.gov