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  1. Non-Profit and Other MOUs

MOU 225-20-015

Memorandum of Understanding
Between the American Association for Cancer Research, the Oncology Nursing Society,
the Hematology/Oncology Pharmacy Association, 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), the American Association for Cancer Research (AACR), the Oncology Nursing Society (ONS), and the Hematology/Oncology Pharmacy Association (HOPA) agree to collaborate in Project Livin’ Label, an educational initiative aimed at increasing awareness of recent FDA oncology drug approvals and understanding of the associated drug product labeling. The FDA, AACR, ONS, and HOPA share interests in promoting scientific progress through exchange of scientific capital in oncology education, collaborative learning, and research. All institutions foresee benefits from collaborating in this educational initiative focused on recent oncology drug approvals and their labeling. 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 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, ONS, and HOPA are consistent with the OCE’s vision and mission.

The mission of AACR 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 mission of ONS is to promote excellence in oncology and nursing and the transformation of cancer care. 
 
The mission of HOPA is to support pharmacy practitioners and promote and advance   hematology/oncology pharmacy to optimize the care of individuals affected by cancer. 

The OCE, AACR, ONS, and HOPA have complementary missions and rely on the expertise of hematologists/oncologists, oncology nurses, and oncology pharmacy practitioners who have up-to-date knowledge on the latest oncology drug approvals and their associated labeling.  Such knowledge may also help educate these individuals 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 an educational initiative, Project Livin’ Label between the OCE, AACR, ONS, and HOPA. 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, ONS, and HOPA, along with the publicly available drug product labeling, and AACR, ONS, and HOPA will disseminate this information to the oncology community. Oncology practitioners, including oncologists, oncology nurses, and oncology pharmacists, can watch the video and review the associated drug product label and receive Continuing Medical Education (CME) and/or Nursing Continuing Professional Development (NCPD) and/or Continuing Pharmacy Education (CPE) credit for this activity.

Roles and Responsibilities of the Parties

  • FDA/OCE will be responsible for:
    •  Developing educational videos on select oncology drug approvals
  • AACR will be responsible for:
    • Notifying members of Project Livin’ Label episodes
    • Coordinating and assigning CME credit
    • Maintaining Project Livin’ Label episodes on their website 
    • Maintaining links to ONS and HOPA websites for claiming professional educational credit (NCPD or CPE)
  • ONS will be responsible for:
    • Notifying members of Project Livin’ Label episodes on AACR’s website
    • Coordinating and assigning CNE credit
  • HOPA will be responsible for:
    • Notifying members of Project Livin’ Label episodes on AACR’s website
    • Coordinating and assigning CPE credit

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. OCE staff participating in this effort, or other joint educational efforts with AACR, ONS, and HOPA, 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, ONS, and HOPA 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 the relevant parties, including FDA. 

IV.     PROMOTIONAL ACTIVITY

The AACR, ONS, and HOPA have no commercial products or commercial services relevant to subject matter of this MOU, and they will not use Project Livin’ Label as a vehicle to sell or promote other educational products or services. Any promotion by AACR, ONS, or HOPA of other educational products or services shall not suggest that FDA is involved in or approves of these other products or services. The use of the FDA and/or AACR and/or ONS and/or HOPA logo will be consistent with the FDA, AACR, ONS, and HOPA logo policies.

V.    PUBLICITY AND ENDORSEMENT

The AACR, ONS, and HOPA agree not to use the name of the FDA or any of the FDA components, except in factual publicity/website notices for Project Livin’ Label. Factual publicity/website notices by AACR, ONS, or HOPA related to Project Livin’ Label shall not imply that the involvement of the FDA on this educational project serves as an endorsement of the general policies, activities, or products of the AACR or ONS or HOPA, or their members, including any research or development efforts related to possible future oncology drugs or treatments. Where confusion could result, publicity should be accompanied by a disclaimer to the effect that no endorsement is intended. The AACR, ONS, and HOPA 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, AACR, ONS, and HOPA’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: jon.retzlaff@aacr.org 

For FDA/OCE:    
    Laura Wisch
    Oncology Center of Excellence 
    Building 22, Room 2243
    Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
    Email: laura.wisch@fda.hhs.gov 

For ONS:
    Jaime Weimer
    Oncology Nursing Society
    125 Enterprise Drive
    Pittsburgh, PA  15275
    Email: jweimer@ons.org

For HOPA:
    Anne Krolikowski
    HOPA
    555 East Wells Street, Suite 1100
    Milwaukee, WI 53202
    Phone: 414-918-9800
    Email: akrolikowski@hoparx.org 

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 January 1, 2027 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 
Date: 05/03/2022

APPROVED AND ACCEPTED BY ONCOLOGY NURSING SOCIETY

/s/
Brenda Nevidjon
Chief Executive Officer
Oncology Nursing Society 
Date: 03/29/2022

APPROVED AND ACCEPTED BY HEMATOLOGY/ONCOLOGY PHARMACY ASSOCIATION

/s/
Anne Krolikowski
Executive Director
Hematology/Oncology Pharmacy Association
Date: 04/06/2022

APPROVED AND ACCEPTED FOR FOOD AND DRUG ADMINISTRATION

/s/
Richard Pazdur, MD
Director
FDA, Oncology Center of Excellence
Date: 05/03/2022
 

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