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MOU 225-20-014

Memorandum of Understanding between the American Medical Association and the Food and Drug Administration U.S. Department of Health and Human Services

I. PURPOSE

This Memorandum of Understanding ("MOU") establishes the framework for a collaboration between the U.S. Food and Drug Administration ("FDA") and the American Medical Association ("AMA") (each a "Party" and collectively the "Parties") that will help facilitate a common goal of developing and disseminating educational and outreach materials on dietary supplements. By targeting the physician audience, FDA and AMA share a mutual goal of increasing understanding and awareness of dietary supplement regulations so physicians can effectively counsel patients on dietary supplement use.

II. BACKGROUND

Food and Drug Administration

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended (21 U.S.C. 301 et seq.). In fulfilling its responsibilities under the FD&C Act, 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. 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. Collaborating with AMA to help develop and disseminate dietary supplement education resources and information to physicians and consumers will further support FDA's mission.

American Medical Association

Since 1847, the American Medical Association has played an important role in the development of medicine in the United States, promoting scientific advancement, improving public health, and investing in the doctor and patient relationship. The AMA recognizes that the use of dietary supplements is prevalent and growing in the United States and consumers may not be well informed about safe supplement use. Physicians and other healthcare providers play a critical role in educating consumers on the appropriate selection and use of dietary supplements to optimize health.

Partnering with AMA to develop materials will increase the reach of FDA’s education efforts and advance FDA and AMA’s public health missions.

III. ROLES AND RESPONSIBILITIES

FDA intends to:

  • Develop education materials to include videos and downloadable patient handout(s) to educate AMA members and other healthcare professionals about dietary supplements that can be used by AMA as a CME module.
    • Engage FDA Subject Matter Experts (SMEs) to review the draft materials for scientific and regulatory accuracy.
    • Solicit comments and edits from designated AMA staff, SMEs and assigned reviewers.
    • Obtain all required FDA clearances for the materials.
    • Provide graphic design services to produce all final materials.
    • Create all final materials in 508-compliant formats, including collateral handout(s) as PDF documents for posting on the Web.
  • Host the final CME materials on FDA's website for the public (no CME credits offered).
  • Promote the CME materials through FDA communication channels.
  • Designate a staff member to provide information for AMA’s Continuing Medical Education (CME) application process, if requested.

AMA intends to:

  • Assign an AMA staff member, SME, and/or content expert reviewer to review the CME materials and provide written feedback to FDA within the timeframes set in the production schedule.
  • Adapt the videos and handout(s) into a module ("CME Module) to provide physicians the opportunity to obtain continuing medical education credit.
  • Manage AMA’s application process to obtain approval to provide CME credit.
  • Host the CME Module on AMA’s website.
  • Offer the CME credits, at no cost, to AMA members.
    • Award CME credits to members who complete the CME Module.
    • CME credits will be available for members for at least 3 years from the launch CME Module.
  • Promote the CME Module through AMA communication channels, such as its website, social media platforms, member communications, and conferences.
  • Provide FDA with quarterly metrics about the number of individuals completing the CME Module, accessed through AMA’s website, and pre- and post-test assessment scores.
  • Identify AMA staff, SMEs, or members to serve as spokespersons in the filming of the CME videos, if requested.

The Parties agree that work will be completed according to a production schedule that will be developed for the CME materials, which will be finalized after this MOU is signed, reviewed by both Parties, and commence when work begins on the project.

IV. GENERAL PROVISIONS

A. Data Sharing Guidelines
The parties intend to share only publicly available information.

B. The Parties acknowledge the final version of the CME materials provided to AMA by FDA in connection with this MOU will be in the public domain, and as such, FDA and AMA shall have full rights to reuse such content for all FDA and AMA purposes, as applicable, and the right to share such content with other collaborators or requestors.

C. AMA will retain sole copyright in the CME Module; AMA commits to making the CME Module accessible to its members free of charge.

D. All activities within the scope of this MOU must comply with Section 508 of the Rehabilitation Act (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.

E. The Parties intend to co-brand all CME materials by including both Parties' names and/or logos in the final materials. Apart from the co-branded CME materials, AMA agrees not to use the name of FDA except in factual publicity regarding the activities covered by this MOU. Such factual publicity shall not imply that the involvement of FDA serves as an endorsement of the general policies, activities, or products of AMA; where confusion could result, publicity will be accompanied by a disclaimer to the effect that no endorsement is intended. AMA will clear all publicity materials related to activities covered by this MOU with FDA to ensure compliance with this paragraph.

F. This MOU does not affect or supersede any existing or future agreements or arrangements between the Parties. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and AMA operate.

V. NEW DEVELOPMENT

In the event there is a development that may make the content of the CME Module obsolete, the Parties will review the continued value of the content presented in the module to determine if it is desirable to continue use of these materials.

In the event one Party believes that the CME Module should no longer be used, but the other Party wishes to continue use, the Party continuing use will remove the name, initials, logo, and attribution to the other Party upon the other Party's request.

In the event that the Parties agree that the CME Module may continue to be used but require edits or other changes in order to ensure the material reflects current regulatory requirements, the Parties will collaborate in the manner outlined in Section Ill of this MOU.

VI. CONTACTS

A. Food and Drug Administration

Sharmi Das
Director, Division of Education, Outreach, and Information
Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration
5001 Campus Drive
College Park, MD 20740
Phone: (240) 402-3786
Email: Sharmi.Das@fda.hhs.gov

B. American Medical Association

Amy B. Cadwallader, PhD
Director, Science and Drug Policy
American Medical Association
330 North Wabash Avenue, Suite 39300
Chicago, Illinois 60611-5885
Phone: (312) 464-4929
Email: Amy.Cadwallader@ama-assn.org

VII. RESOURCE OBLIGATIONS

This MOU represents the broad outline of the Parties’ intent to enter into specific agreements for collaborative efforts in intellectual areas of mutual interest to FDA and AMA. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. This MOU does not create binding, enforceable obligations against any Party. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and AMA operate.

VIII. TERM, TERMINATION, AND MODIFICATION

This MOU becomes effective on the latest date of execution by both Parties and will continue through the lifespan of the CME module (a maximum of 3 years). This MOU may be modified in writing by mutual consent of authorized officials of each Party. Either Party may terminate its participation in this MOU after providing the other Party sixty (60) days written notice of termination. In the event of termination, upon request either Party's name and/or logo shall be removed by the other Party from future use of the CME materials.

Approved and Accepted for U.S. Food and Drug Administration

/S/
Sharmi Das
Director, Division of Education, Outreach, and Information
May 26, 2020

Approved and Accepted for Academy of Nutrition and Dietetics

/S/
Mira Irons
Group VP and Chief, Health and Science Office
May 27, 2020

 
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