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  1. FDA Memoranda of Understanding

MOU 225-19-023

MEMORANDUM OF UNDERSTANDING BETWEEN THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION, OFFICE OF MINORITY HEALTH AND HEALTH EQUITY
AND THE ALLIANCE OF MULTICULTURAL PHYSICIANS

I. Purpose

The United States Food and Drug Administration (FDA) and The Alliance of Multicultural Physicians (The Alliance) share interests in raising awareness to increase diversity of minority participation in clinical trials that evaluate the safety and effectiveness of new drugs and other therapeutic approaches for diverse American patients. The Alliance is a collective of five national organizations - The Association of American Indian Physicians (AAIP), Association of Black Cardiologists (ABC), National Council of Asian Pacific Islander Physicians (NCAPIP), National Hispanic Medical Association (NHMA),and National Medical Association (NMA). These organizations represent over 100,000 physicians serving millions of multicultural communities across the United States and its territories. Both FDA and The Alliance foresee benefits from education, scientific training, and research for achieving health equity. This Memorandum of Understanding (MOU) forms the basis for a strategic framework between FDA and The Alliance to collaborate on the mutual goal of developing educational, outreach, and training initiatives for physicians and the patients they serve to advance health equity. Examples include shared interests in a range of science-based initiatives (e.g. fellowships, internships), research and scientific education to build a diverse workforce, and exchange of scientific information through various platforms.

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, among other things, promotes and protects the public health by ensuring the safety, efficacy, and security of drugs, 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. To accomplish its mission, FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues. Increased development of research, education and outreach partnerships, such as this one with The Alliance will support FDA's mission in reaching underserved populations.

The Alliance of Multicultural Physicians (The Alliance) is known for the promotion of the collective interests of physician advocates and patients of multicultural backgrounds. The Alliance carries out this mission by providing leadership and a collective voice for racial and ethnic minority physicians to advocate better health outcomes for diverse patients and communities. The Alliance has a strong dedication to health equity that necessitates a focus on populations who are traditionally underserved.

We advocate for:

  • Reducing the burden of diseases and conditions that adversely affect Alaska Native, American Indian, Asian, Black/African American, Hispanic, Native Hawaiian, Pacific Islanders and other medically underserved patients and communities, and support the healthcare providers who treat them
  • Seeking funding for research and initiatives that will lead to better understanding, interventions and treatments for our communities.
  • Increasing the diversity of the health professional and scientific workforce and addressing primary healthcare needs through programs in education, research, and service, with emphasis on racial and ethnic minorities and underrepresented or underserved populations throughout the U.S.

III. Substance of Agreement

This MOU forms the basis for the development of scientific collaborations, outreach and educational initiatives which advance public health partnerships between the FDA and The Alliance. The types of initiatives expected to develop from this MOU include, but are not necessarily limited to, the following:

  • Identify opportunities to convene joint meetings for education and research;
  • Conduct outreach to enhance the visibility of the collaboration through mutually agreed approaches, including training activities, meetings, and symposia;
  • Highlight opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
  • Explore research and evaluation collaborations;
  • Support collaborations for development and delivery of culturally and linguistically appropriate educational materials and information about FDA-regulated products for medical providers served by The Alliance and the populations they serve; and through a wide-variety of platforms including but not limited to community organizations, places of worship, and meetings and conferences.
  • Support educational programs, materials, resources, and events that encourage and promote awareness of diverse participation in clinical trials.
  • Identify and provide opportunities to engage in sabbaticals, postdoctoral fellowships, student internships, and/or other research or training programs that involve joint Alliance and FDA research interests and scientific objectives (e.g., continuing education training programs).
  • Identify opportunities for mutually agreed cross representation and participation (e.g. speaker, board member) on advisory committees/boards, working groups, lectures, public meetings, forums, and other venues as appropriate.
  • Explore cooperative international initiatives; and
  • Accessing unique facilities and equipment for scientific endeavors.

Under this MOU, FDA and The Alliance intend to seek opportunities to participate together in collaborative research and training, as permitted under appropriate statutory authority. Before any specific collaboration is initiated or implemented, the Participants intend to identify priorities and topics of mutual interest and develop separate, written arrangements for collaboration and resourcesharing. The Participants intend that, when applicable, these arrangements incorporate by reference this MOU.

IV. General Provisions

The Participants intend that:

  1. Rights to any inventions resulting from collaborative research will be determined by the separate written research arrangements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.
  2. The Alliance and FDA may decide to enter Cooperative Research and Development Agreements (CRADA) for specific collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
  3. Proprietary and/or nonpublic information may not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality and disclosure arrangements and to the extent that such disclosure is permitted by U.S. federal law.
  4. Each Participant will comply with the other Participant's security procedures and policies regarding access to and use of facilities. Either Participant may restrict or limit access to its property and facilities at any time and for any reason. The Participants intend that individuals participating in activities under this MOU on FDA property comply with applicable U.S. federal law.
  5. It is recognized that from time to time, FDA and The Alliance may share expenses and may request compensation to one Participant by the other. The Participants intend that, as research projects are developed, details of how costs are to be shared shall be agreed to in advance under appropriate contractual mechanisms and in compliance with all applicable U.S. federal requirements.

V. Resource Obligations:

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

VI. Contacts:

A. For The Alliance:
Executive Director, National Medical Association
Suite 820
8403 Colesville Road
Silver Spring, MD 20910
phone:202-347-1895

B. For the U.S. Food and Drug Administration:
Jovonni Spinner
Office of Minority Health and Health Equity
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Phone: (301) 796-8729

Each Participant may designate new liaisons at any time by notifying the other Participant's administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Participant previously represented by that individual should name a new liaison within two (2) weeks and notify the other Participant through the designated administrative liaison.

VII. Term, Termination, and Modification:

This MOU, when accepted by both Participants, will be effective upon the date of the last signature. It may be modified or terminated by mutual written consent of the parties or may be terminated by either party upon 60-days written notice to the other.

VIII. Statutes, Regulations, Rules, and Policies:

This MOU and all associated arrangements will be subject to the applicable statutes, regulations, rules, and policies under which FDA and the institutions within The Alliance operate.

APPROVED AND ACCEPTED FOR THE ALLIANCE OF MULTICULTURAL PHYSICIANS

/s/
Winston Wong, Chair, NCAPIP
7/3/2019

/s/
Elena Rios, Executive Director, NHMA
7/3/2019

/s/
Niva Lubin Johnson, President, NMA
7/19/2019

/s/
Cheryl Pegus, Chair, ABC
7/24/2019

/s/
Walter Hollow, President, AAIP
7/19/2019

APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION

/s/
CAPT Richardae Araojo, Pharm.D., MS
Associate Commissioner for Minority Health
06/19/2019