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  1. FDA Memoranda of Understanding

MOU 225-16-002

MOU 225-16-002

MEMORANDUM OF UNDERSTANDING
BETWEEN U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEACH
AND NATIONAL CONSUMERS LEAGUE

I. Purpose

This Memorandum of Understanding (MOU) defines the framework for collaboration between the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) and the National Consumers League (NCL). FDA and NCL have a common interest in protecting and promoting public health. FDA and NCL will collaborate in educating the public about health issues.

II. Authority

FDA has authority to provide information to the public pursuant to section 705(b) and section 1003(d)(2)(D) of the Federal, Drug, and Cosmetic Act, 21 U.S.C. sections 375(b) and 393(d)(2)(D).

Background

Food and Drug Administration

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (The Act) as amended (21 U.S.C. 301, e seq.). In fulfilling its responsibilities under the Act, FDA, among other things, directs it activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, and medical devices and the safety and security of foods, dietary supplements, cosmetics, and radiological products. To protect the public health and to reduce tobacco use by minors, FDA also has responsibility for ensuring appropriate regulation of the manufacturing marketing and distribution of tobacco products. The Center for Drug Evaluation and Research (CDER) within FDA is responsible for the safety efficacy and security of human drugs. CDER promotes and protects the public health by ensuring the safe and effective drugs are available to Americans. In addition, CDER’s long-term objectives include protection of the public by ensuring the quality and integrity of marketed drug products and promotion of the safe use of marketed drugs. CDER carries out its mission in consultation with experts in science, medicine, and public health and in cooperation with consumers, health care professionals and other stakeholders.

The National Consumers League

The National Consumers League (NCL is a Washington, D.C. based 501(3)c nonprofit consumer advocacy group representing consumers on marketplace and workplace issues, including those related to health. As the nation’s oldest consumer organization, NCL provides government, businesses, and other organizations with the consumer’s perspective on concerns included related to drug use and safety, and other health issues. NCL’s mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. Through this partnership, the NCL will be able to further educate consumers about health issues, including how to understand and use drugs safely and effectively.

III. Substance of Understanding

CDER will participate in the national Consumers League Health Advisory Council b providing information and perspectives on health issues. Through the Council, NCL intends to:

  1. Convene a diverse membership of organizations working in the health care arena, including government agencies, patient and consumer advocacy groups, healthcare professionals, provider organizations, foundations, health plans, pharmaceutical companies, research institutions, and others in disease health education and advocacy.
  2. Provide a forum for members to share perspectives and insights, and identify common interests.
  3. Provide a quarterly newsletter, which will highlight health issues of interest to members.
  4. Uphold the mission of the Health Advisory Council to share perspective and insight, identify common interests, and lay a foundation of support for NCL’s work in health-related consumer education and advocacy.

IV. General Provisions

A. U.S. Federal law govern this MOU for all purposes, including, but not limited to, determining the validity of the MOU, the meaning of its provisions and the rights, obligations, and remedies of the Parties.

B. FDA will not provide NCL access to any document or information that by providing such access would place the FDA in breach of the Trade Secrets Act, codified at 18 U.S.C. sec. 1905; the Privacy Act, codified at 5 U.S.C. sec. 552a; the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. sec. 301, et seq. (particularly 21 U.S.C. sec 331 (j); FDA regulations (21 Code of Federal Regulations (CFR); or any other Federal law or regulation.

C. This MOU does not grant exclusivity to either party, nor does it restrict CDER or NCL from participating in similar initiatives with other public or private agencies, organizations, or individuals.

D. NCL agrees to promote the FDA’s health information on its WEB site, as appropriate. Through this online portal, mobile applications and/or print publication, NCL will offer consumers, community-based organization, caregivers, and health care professionals information resources and communications services.

E. FDA health information must be easily distinguishable from non-FDA content on the NCL Web site. FDA health information place on NCL’s Web site should be clearly identified as such.

F. Printed materials and online Web pages containing FDA health information provided by CDER pursuant to this MOU must be free of advertisements, and otherwise must avoid implying FDA’s endorsement of support for a part product, service, or Web site.

G. NCL agrees maintain current FDA health information on its Web site. FDA health information must be removed from the NCL. Web site in the following circumstances: (1) within 3 years of the date of its first publication; (2) upon termination of this MOU, if it terminates less than 3 years after the material is posted; (3) upon FDA’s request in circumstances in which the information becomes outdated; or (4) as soon as commercially practicable but no longer than 72 hours after receipt of a written request from FDA to remove the material, regardless of reason. NCL’s failure to display current FDA health information or to remove such information in accordance with this MOU may result in the termination of this MOU.

H. FDA and NCL recognize that this MOU is not intended to, and may not be relied on to created right or benefit substantive or procedural, enforceable by law by any party against the United States or NCL. Nothing in this MOU alters the statutory authorities or obligations of FDA.

I. All materials and programming produced pursuant to this collaboration must be accessible by and free of cost to the general public.

J. All activities within the scope of the MOU must comply with section 508 of the Rehabilitation Act (29 U.S.C. section 794d), as amended by the Workforce Investment Act of 1998, Pub. L. No. 105-220, August 7, 1998 (see U.S. Department of Health and Human Services policy on Section 508 compliance).

K. NCL agrees that content provided to NCL by CDER in the course of this collaboration shall be public domain materials and as such, FDA shall have full rights to reuse such collaborators or requestors.

L. The FDA allows NCL to identify FDA as “a Member” of its Health Advisory Council and allows NCL to list FDA as a member of this Council on its Web site. FDA retains the right to review all other materials listing FDA and/or the Center for Drug Evaluation and Research as a member of the Health Advisory Council prior to NCL’s public distribution or posting of such materials, and the right to prohibit the public distribution or posting of such materials.

M. CDER and NCL will cooperative in the maintenance of each Party’s trademarks and logos. NCL agrees that it will not use any FDA logos for marketing purposes other than to promote activities related to FDA’s membership in the Health Advisory Council pursuant to this agreement. The use of FDA names and logos shall not imply any exclusive arrangement. NCL will inform CDER’s Office of Communications about which FDA logo(s) it is requesting to use, and about all applications where the logo(s) will be used and about placement on designated applications. Any use of FDAS logo(s) must be approved, in advance, by CDER’s Office of Communications and adhere to published FDA logo policies. Once CDER approval is received, CDER will send the necessary jpg files for use by NCL.

N. This MOU does not and is not intended to transfer to any party any rights in any technology or intellectual property of any other Party hereto, other than NCL’s ability to display the FDA logos subject to the restrictions specified under paragraph K above. For avoidance of doubt, any intellectual property including, without limitation, content, products, technology, data and other information, provided by NCL for use in the collaboration shall I all cases remain solely owned by NCL, as applicable, and no license to use such information is granted under this MOU.

V. Representations and Warranties

  1. The Partners have all licenses, right, title, and interest to enter and perform their respective obligations under this MOU.
  2. Neither the goods, nor the services nor any other material or things provided to one Partner by or for the other by this MOU will infringe or violate any intellectual property proprietary or other right of any third-Partners.

VI. Links

FDA and NCL will provide inbound and outbound links to and from the NCL Web page and the DA’s Web page when appropriate.

VII. Liaison Officers

A. For NCL

Terry Kush
Managing Director
1701 K Street, N.W., Suite 1200
Washington, D.C. 20006
202-207-2827

B. For FDA

Kimberly Rawlings
CDER/OCOMM
Acting Director, Division of Health Communications
10001 New Hampshire Avenue, Room 4110
Silver Spring, M.D., 20993
301-796-3818

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 two weeks and notify the other Party through the designated administrative liaison.

VIII. Term, Termination, and Modification

This MOU when accepted by all participating Partners will have an effective period of performance from the date of the latest signature until three (3) years from the date of signature by the later Partner to sign it. This MOU may be modified or terminated by mutual written consent by both Partners or may be terminated by either Partner upon a 60-day advance written notice to the other.

IX. Resource Obligations

Sources of support from projects under this MOU will be governed by State and Federal Law and applicable policies and procedures. The terms for such support will be set forth in the specific and separate written agreements for each project. The MOU does not create binding enforceable obligations against any Party. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. NCL is not being compensated by DFA for the activities conducted under the MOU, and funds are not otherwise being obligated under the MOU. 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 DFA and NCL operate.

X. Limitations on Liability

In no event will either partner be liable to the other under any theory of liability, however, arising, or for any costs of cover or for indirect, special, incidental, or consequential damages arising out of this MOU. The provisions of this Section X shall survive termination, cancellation, or expiration of this MOU or any reason whatsoever.

XI. Signatures of Responsible Partner(s)

APPROVED AND ACCEPTED FOR THE NATIONAL CONSUMERS LEAGUE 
Sally Greenberg, JD
Executive Director
National Consumers League
November 5, 2015

APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION 
Janet Woodcock, MD
Director, Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Department of Health and Human Services 
November 11, 2015