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MOU 225-18-005

Memorandum of Understanding Between
the U.S. Agency for International Development
and U.S. Department of Health and Human Services
Food and Drug Administration to Collaborate on Testing of the Counterfeit Detection Device

 

  Table of Contents

  1. Purpose
  2. Goals
  3. Possible Future Activities:
  4. Background:
  5. Scope of the CD-3 Testing Program in Ghana:
  6. Roles and Responsibilities:
  7. Protection of Confidential Information
  8. Resource Obligations:
  9. Liaison Officers:
  10. Term, Termination, and Modification:
  11. Appendix A

I. Purpose:

The Participants to this Memorandum of Understanding (MOU) are the U.S. Agency for International Development, hereinafter referred to as “USAID,” and the U.S. Department of Health and Human Services, Food and Drug Administration, hereinafter referred to as “US FDA.” 

The purpose of this MOU is to establish the framework between US FDA and USAID for testing the ability of the Counterfeit Detection Device, hereinafter referred to as “CD-3”, to identify counterfeit, including falsified products, and substandard anti-malarial drugs in Ghana.  This effort is intended to yield information on the technical capability of the tool to detect counterfeits and substandard products, and inform US FDA and partner country actions aimed at protecting both the global supply chain and American consumers from counterfeit or substandard drugs. 

US FDA and USAID, through a larger partnership which includes the National Institutes of Health (NIH), the Center for Disease Control and Prevention (CDC), the United States Pharmacopeia (USP), and Skoll Global Health Threats will endeavor to focus activities on optimizing the use of the CD-3 for the identification of counterfeit or substandard anti-malarial drugs by leveraging existing activities associated with the ongoing sampling and testing activities of the President’s Malaria Initiative (PMI) where there are high rates of malaria and where counterfeit or substandard anti-malarial drugs have previously been detected.
 

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II. Goals:

  1. Enhance information sharing and collaboration between US FDA and USAID.
  2. Promote efficient utilization of interagency expertise, technologies, and tools to improve product risk identification, validation, and analysis.
  3. Leverage ongoing sampling and testing to identify counterfeit or substandard drugs.
  4. Build interagency infrastructure and processes to increase the protection of the global supply chain integrity.

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III. Possible Future Activities:

In addition to the sampling and testing program, through an amendment to the MOU in accordance with Section IX, the activities may be expanded to:

  1. Address subsequent testing and implementation activities in other geographic regions;
  2. Assess deployment of the CD-3.
  3. Include expansion of collaboration by both the Participants. The expansion may include other domestic Federal and quasi-governmental agencies, international nonprofit organizations, foreign governments, industry and other domestic and international stakeholders.  Additional partners may join the consortium; and/or
  4. Include any other activities mutually agreed upon.

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IV. Background:

US FDA has continued responsibility under the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. §§ 301, et seq.) (the Act), to, among other things, promote and protect the public health by assuring the safety, efficacy, and security of drugs, veterinary products, and medical devices, and the safety and security of conventional foods, dietary supplements, cosmetics, and radiological products.  US 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. To accomplish its mission, US FDA stays abreast of the latest developments in research and communicates with stakeholders about complex scientific and public health issues. Increased investment and development of research, education, and outreach partnerships to prevent, detect, and respond to counterfeits, including falsified products and substandard drugs, will help US FDA fulfill its responsibilities.

USAID/PMI is established in 19 focus countries in sub-Saharan Africa and the Greater Mekong Sub-region in Asia to build their capacity to prevent and treat malaria using proven effective control activities, based on country-level assessments, for which a combination of interventions are implemented to achieve the greatest public health impact through the reduction of malaria morbidity and mortality.  With financing from the PMI, USAID, through its cooperative agreement (GHS-A-00-09-00003) with USP for the Promoting the Quality of Medicines Program (PQM) currently collaborates with the Ghanaian Food and Drug Authority to conduct existing surveillance programs in Ghana, using semi-quantitative screening methodologies to determine drug identity and content for various drug products, and provides information to Ghanaian regulatory authorities for government enforcement action when suspect counterfeit or substandard products are identified.  In addition to field screening, the Ghanaian quality control laboratory conducts further testing of products as needed.  The efforts under this MOU are intended to leverage the existing PQM Program’s ongoing sampling and testing in malaria endemic regions in Ghana to test CD-3 to provide information on capabilities and deployment of the tool in actual field settings.

The President’s Malaria Initiative, launched June 30, 2005, pledged to increase U.S. Government funding of malaria prevention and treatment by $1.2 billion over five years.  The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 (Hyde-Lantos legislation) authorizes up to $5 billion in funding for malaria prevention and control, and expanded the number endemic countries in Africa.  In Fiscal Year 2011, four additional countries joined PMI, bringing the total number of PMI focus countries to nineteen. 

Under the Hyde-Lantos legislation, PMI was expanded to include support to Greater Mekong Sub-region (although the United States Government (USG) had been providing support since 2000).  PMI will work with national governments and global partners to halve the burden of malaria in 70 percent of the at-risk populations in sub-Saharan Africa in the original 15 focus countries, and achieve a 50 percent reduction in additional countries over the six-year funding period (2009-2014) of the U.S. Government Global Health Initiative.  One of the strategies to meet this ambitious goal is to manage morbidity and mortality, particularly under-five mortality, related to malaria infection through the use of proven drugs and through prompt and effective diagnosis, care and treatment.
 

V. Scope of the CD-3 Testing Program in Ghana:

  1. The CD-3 testing program in Ghana is intended to leverage existing PMI/Ghana financing and technical support for in-country surveillance systems supported by the Ghana FDA, and technical assistance from the PQM Program to implement a testing program for anti-malarial drugs at five already-established USP sites.  US FDA expects to provide USP with ten CD-3s with funding from Skoll.
  2. The Participants envision that USP will deploy the CD-3 alongside the existing screening technology to test several brands of World Health Organization (WHO) prequalified anti-malarial combination therapies which are available on the Ghanaian market, including artemether + lumifantrine and artesunate + amodiaquine.
  3. The testing program is intended to compare the results obtained from CD-3 with those from the other screening technologies currently being used. A second testing program is being developed, building on the data obtained in Ghana.  Funding and program details are still in development for the second phase.
  4. The testing in Ghana is intended to occur at five USP sentinel sites, provincial towns in Ghana, where existing minilabs are currently deployed, with plans to later conduct screening in a second location, yet to be determined. The Participants intend that samples will be obtained from various levels in the distribution chain in Ghana, including hospitals, clinics, and pharmacies (public and private), and brought to the sentinel sites for testing. The Participants intend that confirmatory testing of suspect products will be done at the Ghanaian quality control laboratory and the results will be provided to Ghanaian regulatory authorities for government enforcement action.
  5.  USAID’s use of the USP PQM Program to meet the goals of this MOU is subject to available funding, and other programmatic and regulatory restrictions and considerations.

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VI. Roles and Responsibilities:

  1. Partnership

    This MOU is between USAID and US FDA but it is recognized that the Participants are working with other partner organizations to test CD-3. The roles of the Participants and their partners are described below.
    1. USAID intends to contribute to the activity through the PQM Program, whereby its implementing partner, USP will test the CD-3 during the implementation of on-going PMI sampling and testing activities carried out by the PQM Program.  USAID intends to be a primary provider of programmatic and logistics planning, expertise, and support for the CD-3 testing program in Ghana.  The Participants intend to jointly provide strategic leadership for the CD-3 testing program in Ghana. USAID intends to supervise USP’s activities in Ghana and provide technical input.  USAID intends to provide management and oversight of the PQM Program, including approval of all reporting and work plans.  USAID will provide US FDA with an opportunity to comment on work plans and reports relating to the CD-3 testing program, and access to CD-3 testing data, redacted to remove sensitive data.
    2. US FDA intends to provide ten CD-3s to USP for testing programs at five USP sentinel sites in Ghana, as well as the requisite expertise, training, and staff to support the function of the CD-3 for the testing program in Ghana.   US FDA intends to enter into a Letter of Transfer and Non-Disclosure Agreement with USP, attached as Appendix A.  The Participants intend to jointly provide strategic leadership for the CD-3 testing program in Ghana.
    3. USP – The Participants envision that USP will develop the protocol, conduct sampling and testing in partnership with the Ghana FDA, and contribute to the analysis of findings.  The Participants intend that USP will report on the results of the testing as part of its programmatic reporting.  USAID reserves the right to modify the activities undertaken by USP based on Agency needs/requirements.
    4. The Skoll Global Threats Fund – The Participants envision that Skoll will fund the initial CD-3 testing program in Ghana by funding the procurement of additional tools and testing of authentics to develop product libraries.
    5. CDC and NIH - The Participants envision that CDC and NIH will contribute to the protocol development and provide other technical assistance as needed.;
  2. Communication Modalities
    1. USAID - The Participants intend for USAID to manage communications with Ghana FDA and Ghana’s Ministry of Health, and be copied on communications related to the CD-3 testing program with USP.
    2. US FDA – The Participants intend for US FDA to be primary coordinator for media/press related to the Ghana testing program for the CD-3.  The Participants intend for US FDA to draft communications for public release, with prior approval from USAID, and prior courtesy notification to USP and Skoll.  The Participants acknowledge that US FDA may communicate directly with the Ghana FDA on regulatory matters identified through the course of the testing program.

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VII. Protection of Confidential Information

  1. Information to be Protected

    1. “Confidential Information” is defined as any of the following types of information:
      1. preliminary results of testing of the CD-3 tool (US FDA and USAID intend for a final report to be made public);
      2. information that could enable reverse-engineering of the CD-3 tool;
      3. the library of authentic product information that enables comparison of a suspect product in the field to an authentic product;
      4. any other information that US FDA or USAID marks as “Confidential,” with the exception of the types of information identified in section VII.A.2. below.
    2. "Confidential Information" does not include information that:

      1. can be demonstrated to be in the public domain or publicly known, not due to any unauthorized act by the receiving Participant; or
      2. can be demonstrated to be in the possession of, or readily available to, the receiving Participant from another source; or
      3. can be demonstrated to have been independently developed by the receiving Participant without reference to or reliance upon Confidential Information.
    3. US FDA and USAID do not intend to share any trade secrets, confidential commercial information, or personal privacy information with each other.
  2. Access to Confidential Information:
    The Participants should establish proper safeguards to ensure that Confidential Information shared under this MOU is used and disclosed solely in accordance with the terms of this MOU. Access to Confidential Information shared under this MOU should be restricted to US FDA, USAID, Ghanaian Ministry of Health, and Ghana FDA employees and contractors who require access to the information to perform their duties as authorized by this MOU. This includes use by the Ghanaian Ministry of Health and Ghana FDA for regulatory and public health purposes. Such personnel should be advised of the confidential nature of the information and the safeguards required to protect the information. The Participants intend to have contractors, their subcontractors, and agents requiring access to Confidential Information sign a confidentiality agreement by which they commit to keep the information confidential. Confidential Information should not be further shared, except with the written permission of the sharing Participant, or as may be required by law, in which case as much advance written notice as is practical under the circumstances should be provided to the sharing Participant.
  3. Process for Sharing Confidential Information:

    Whenever Confidential Information is provided from one Participant to another, the Participant providing the information should clearly indicate in its communication that it is providing Confidential Information, clearly mark any document containing Confidential Information “Confidential,” and request acknowledgment of receipt of the information and indicate that it is to be treated confidentially in accordance with this MOU. Confidential Information shared verbally should be reduced to writing, marked “Confidential,” and communicated to the other Participant, if appropriate. The Participant receiving the Confidential Information should acknowledge receipt of the information and its commitment not to further share the information except as provided in the MOU, with the permission of the other Participant, or as may be required by law.
  4. Third Party Requests for Shared Confidential Information:

    If either Participant receives a third party request for information that includes Confidential Information received from the other Participant, such as a Freedom of Information Act (FOIA) request, Congressional request, discovery request, or subpoena, the Participant receiving such a request should promptly notify the Liaison Office of the other Participant. The Participants should confer regarding how to respond to such a request, including whether to refer the request to the other Participant to respond to directly.

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VIII. Resource Obligations:

This MOU establishes the framework between US FDA and USAID for testing the CD-3. Nothing in this MOU is intended to create binding obligations under the law or diminish or otherwise affect the authority of either Participant to carry out its respective statutory functions. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and appropriated funds. This MOU is not intended to affect existing agreements or arrangements between the Participants and is not intended to preclude the Participants from entering into future separate agreements or arrangements. The Participants intend for this MOU and all associated agreements and arrangements to be subject to the applicable policies, rules, regulations, and statutes under which US FDA and USAID operate.

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IX. Liaison Officers:

  1. For USAID:

    Individual’s name: Julie Wallace, BSN, MN, MPH
    Title: Malaria Division Chief/USAID PMI Team Lead
    Address: U.S. Agency for International Development
    1300 Pennsylvania Ave NW
    Washington, D.C. 20523

    Telephone Number: (202) 712-0428
     
  2. For US FDA:

    Individual’s name: S. Leigh Verbois, PhD
    Title: Director, Asia Pacific Office
    Address: U.S. Food & Drug Administration
    10903 New Hampshire Avenue
    Building 32
    Silver Spring, MD 20993

    Telephone Number: (301) 796-4600

The Participants intend that either Participant may designate a new liaison by notifying the other Participant's liaison in writing. The Participants also intend that, if an individual designated as a liaison under this MOU becomes unavailable to fulfill those functions, that Participant will name a new liaison within two (2) weeks and notify the other Participant through the designated liaison.

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X. Term, Termination, and Modification:

This MOU takes effect upon signing by both Participants. This MOU may be amended or terminated by mutual written consent by both the Participants or may be terminated by either Participant(s) upon a 30 day advance written notice to the other.

APPROVED AND ACCEPTED FOR
United States Agency for International Development
By _____/s/________
Robert Clay

Deputy Assistant Administrator for the Bureau of Global Health

U.S. Agency for International Development
1300 Pennsylvania Ave NW
Washington, DC 20523
Date 4/21/14

APPROVED AND ACCEPTED FOR
United States Food and Drug Administration

By  ______/s/_______
       Howard Sklamberg, J.D.

Deputy Commissioner for Global Regulatory Operations and Policy

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Date 4/18/14

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Appendix A – Letter of Transfer and Non-Disclosure Agreement
Between U.S. Food and Drug Administration and U.S. Pharmacopeial Convention
For Testing of FDA’s Counterfeit Detection Device

The U.S. Food and Drug Administration (US FDA) invented and owns the CD-3 Counterfeit Detection Device (CD-3), a patent pending technology under US Patent Application Number 13262371 and EP Patent Application Number 10728465. Under this Letter of Transfer (LOT) between US FDA and the U.S. Pharmacopeial Convention (USP), ten CD-3s are provided by US FDA to USP testing sites in Ghana.

I. Use of Transferred CD-3s

The CD-3s may only be used for the testing program described in the MOU referenced above. USP will not further distribute CD-3s. USP will not duplicate or reverse engineer the CD-3s. USP will consult with FDA if any modifications to the CD-3s are necessary to carry out the collaborative work. USP understands that when the testing is completed, USP will return CD-3s to USFDA or will dispose of according CD-3s according to the written instructions of US FDA, unless USP obtains permission from USFDA to continue using CD-3s.

Number of CD-3 units transferred to USP: 10

The USP PI or POC will acknowledge receipt of the CD-3s by signing this LOT in the signature block below. USP PI will email a scanned copy of the signed LOT to the following US FDA provider:

Provider Information

Organization Name
US FDA

Organization Address:
10903 New Hamphire Avenue
Silver Spring, MD 20993

Principal Investigator (PI) or Point of Contact (POC) Name:
S. Leigh Verbois

Authorizing Official Name
---/s/---

Tel: 301-796-4600
Fax:

Recipient Information

Organization Name
USP

Organization Address:
1206 Twinbrook PKWY
Rockville, MD 20886

Principal Investigator (PI) or Point of Contact (POC) Name:
Daniel Bempong

Authorizing Official Name
---/s/---

Tel: 301-646-8713
Fax:

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II. Non-Disclosure Agreement

WHEREAS, USP has agreed to perform testing of US FDA’s Counterfeit Detection Device, and its anti-counterfeit programs will benefit from such testing;

WHEREAS, US FDA has information that would facilitate USP’s testing of the Counterfeit Detection Device, including Confidential Information, as defined in the MOU between USAID and US FDA to Collaborate on Testing of the Counterfeit Detection Device dated [ ];

NOW, THEREFORE, in consideration of the foregoing, and intending to be legally bound hereby, US FDA and USP hereto agree as follows:

  1. US FDA shall provide information to USP to facilitate USP’s testing of the Counterfeit Detection Device, which includes Confidential Information.
    1. “Confidential Information” is defined as any of the following types of information:
      1. preliminary results of testing of the CD-3 tool (US FDA and USAID intend for a final report to be made public)
      2. information that could enable reverse-engineering of the CD-3 tool;
      3. the library of authentic product information that enables comparison of a suspect product in the field to an authentic product;
      4. any other information that US FDA or USAID marks as “Confidential,” with the exception of the types of information identified in section II.A.2. below.
    2. “Confidential Information” does not include information that:
      1. can be demonstrated to be in the public domain or publicly known, not due to any unauthorized act by the receiving Participant; or
      2. can be demonstrated to be in the possession of, or readily available to, the receiving Participant from another source; or
      3. can be demonstrated to have been independently developed by the receiving Participant without reference to or reliance upon Confidential Information.
    3. US FDA and USAID do not intend to share any trade secrets, confidential commercial information, or personal privacy information with each other.
  2. USP shall not disclose Confidential Information to anyone except USAID, US FDA, or Ghana FDA employees.
  3. USP agrees to employ all reasonable efforts to maintain the confidentiality of Confidential Information, whether created by or provided to USP, such efforts must be no less than the degree of care employed by USP to preserve and safeguard its own confidential information.
  4. USP must have any subcontractors and agents requiring access to Confidential Information sign a confidentiality agreement by which they commit to keep the information confidential.
  5. USP must mark Confidential Information as “Confidential Information”.
  6. USP must communicate or share Confidential Information with US FDA through USAID.
  7. If USP receives a third party request for information that includes Confidential Information such as a Congressional request, discovery request, or subpoena, USP must promptly notify the Liaison Office of US FDA and USAID.
  8. It is understood that nothing herein shall be deemed to constitute, by implication or otherwise, the grant to USP of any license or other rights under any patent, patent application or other intellectual property right or interest belonging to US FDA.
  9. It is understood and agreed by the parties, that each represents and warrants to the other Party, that the official signing this Agreement on behalf of the Party has authority to do so.
  10. The illegality or invalidity of any provision of this Agreement shall not impair, affect or invalidate the other provisions of this Agreement.
  11. The construction, validity, performance and effect of this Agreement shall be governed by Federal law, as applied by the Federal Courts in the District of Columbia.

Agreed to by Provider and Recipient Authorizing Officials

For US FDA
---/s/---
Signature

April 28, 2014
Date

For USP
---/s/---
Signature

April 28, 2014
Date

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