MEMORANDUM OF UNDERSTANDING BETWEEN THE AMERICAN ASSOCIATION FOR CANCER RESEARCH AND THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION, ONCOLOGY CENTER OF EXCELLENCE

I. PURPOSE

The Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) and the American Association for Cancer Research (AACR) agree to collaborate in Project Livin’ Label, a new educational initiative aimed at increasing awareness of recent FDA oncology drug approvals and understanding of the associated drug product label. The FDA and AACR share interests in promoting scientific progress through exchange of scientific capital in oncology education, collaborative learning, and research. Both institutions foresee benefits from collaborating in this new educational initiative focused on regulatory policy. This Memorandum of Understanding (MOU) establishes the terms for the collaboration for Project Livin’ Label and provides a basis for other related efforts to promote these shared, mutual interests in collaborative education and learning.

II. BACKGROUND

The 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, the 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.  The 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, the 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 within the AACR will greatly contribute to FDA’s mission. 

The mission of the OCE is to achieve patient-centered regulatory decision-making through innovation and collaboration. The OCE’s vision is to create a unified and collaborative scientific environment to advance the development and regulation of oncology products for patients with cancer. The OCE leverages the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, devices, and diagnostics. The OCE helps expedite development of medical products for solid tumors and hematologic malignancies and supports an integrated approach to their clinical evaluation. Proactive scientific education and collaboration with the AACR is consistent with the OCE’s vision and mission.

The mission of the American Association for Cancer Research is to prevent and cure all cancers through research, education, communication, collaboration, research funding, and advocacy. The AACR's vision includes that all cancer patients will have lifelong access to high quality, effective, affordable and compassionate care. Through its programs and services, the AACR fosters research in cancer and the related sciences; accelerates the dissemination of new research findings among scientists and others dedicated to the conquest of cancer; promotes science education and training; and advances the understanding of cancer etiology, prevention, detection, diagnosis, and treatment of cancer throughout the world.

The OCE and AACR have complementary missions and rely on the expertise of hematologists/oncologists and scientists that are well-trained on the fundamentals of drug and diagnostic development and approval. Such individuals work in every sector, from academia to industry to government to clinical practice. This educational initiative will help to provide insight and transparency into the approvals of selected FDA oncology drugs.

III. SUBSTANCE OF AGREEMENT

This MOU is the foundation for establishing a new educational initiative, Project Livin’ Label between the OCE and the AACR. The objective of this effort is to educate the oncology community about select recent oncology drug approvals. The FDA will develop an educational video on a select recent oncology drug approval, discussing aspects found within the drug product label, such as safety findings and efficacy results. The FDA may choose to invite external guests to participate in the discussions. The FDA will share this video with AACR, along with the publicly available drug product label, and the AACR will disseminate this information to the oncology community. Oncology practitioners can watch the video and review the associated drug product label and receive Continuing Medical Education (CME) credit for this activity.

Roles and Responsibilities of the Parties

• The AACR will be responsible for:
  • Advertisement and promotion of Project Livin’ Label
  • Coordination and assignment of CME credit

• The FDA will be responsible for:
  • Development of the educational video on select oncology drug approvals

The sharing of non-public information is not permitted under the terms of this MOU, including FDA non-public information, confidential commercial and/or trade secret information in FDA’s possession, and/or AACR non-public information.  OCE staff participating in this effort, or other joint educational efforts with AACR, shall not further release, publish, or disclose FDA non-public information, and/or or confidential commercial or trade secret information, and they shall protect such information in accordance with the provisions of 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, and other pertinent laws and regulations governing the confidentiality of such information.

AACR will not edit the FDA educational video in any way. Any use of quotes from the video or clips from the video must first be discussed with the FDA and agreed upon by both parties.

IV.  PROMOTIONAL ACTIVITY

The AACR has no commercial products or commercial services and will not use Project Livin’ Label as a vehicle to sell or promote commercial products or commercial services. The use of the FDA and/or AACR logo will be consistent with the FDA and AACR’s logo policy.

V. PUBLICITY AND ENDORSEMENT

The AACR agrees not to use the name of the FDA or any of the FDA components, except in factual publicity for Project Livin’ Label. Such factual publicity shall not imply that the involvement of the FDA serves as an endorsement of the general policies, activities, or products of the AACR. Where confusion could result, publicity should be accompanied by a disclaimer to the effect that no endorsement is intended. The AACR will clear all publicity materials with FDA to ensure compliance with this paragraph.

VI.  TERMINATION

Non-adherence to the terms of this agreement may result in the FDA terminating the agreement.

VII. RESOURCE OBLIGATIONS

This MOU represents the broad outline of the FDA and AACR’s 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 either 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. Separate additional educational activities may be planned (e.g. workshop, lectures, etc.). 

VIII. LIAISON OFFICERS

For AACR: 
 Jon Retzlaff
 AACR
 1401 H Street, NW Suite 740
 Washington DC 20005
 Phone: 202-898-6499
 Email: [email protected]

For FDA/OCE: 
 Jennifer Gao
Oncology Center of Excellence
Building 22, Room 2135
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
[email protected]

Each Party may designate new liaisons at any time by notifying the other Party'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 Parties will name a new liaison within 2 weeks and notify the other Party through the designated administrative liaison.

IX. TERMS, TERMINATION, AND MODIFICATION

This agreement, when accepted by all partners, will have an effective period of performance from the date of the latest signature until September 30, 2025 and may be modified or terminated by mutual written consent of the Partners or may be terminated by either Partner(s) upon a 14 day advance written notice to the other.

APPROVED AND ACCEPTED BY AMERICAN ASSOCIATION FOR CANCER RESEARCH
/s/
Margaret Foti, PhD, MD (hc)
Chief Executive Officer
American Association for Cancer Research
June 11, 2020

APPROVED AND ACCEPTED FOR FOOD AND DRUG ADMINISTRATION
Richard Pazdur, MD
Director
FDA, Oncology Center of Excellence
June 11, 2020