MOU 225-18-008
Memorandum of Understanding Between the U.S. Department of Health and Human Services, Food and Drug Administration, and the National Organization For Rare Disorders
I. Purpose
This Memorandum of Understanding (MOU) defines the framework for collaboration between the Food and Drug Administration (FDA) and the National Organization for Rare Disorders (NORD). FDA and NORD share a common goal to improve the safety of the American public when using FDA-regulated medical products. FDA and NORD will collaborate to promote scientific progress in innovation, patient education, drug safety communications, training, research, including risk evaluation and mitigation strategies (REMS), and adverse event reporting. Before any specific collaboration is initiated or implemented, the parties shall develop separate written agreements for collaborations. Where applicable, the agreements shall incorporate by reference this MOU.
II. 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, et seq.). In fulfilling its responsibilities under the Act, FDA promotes and protects the public health by assuring the safety, efficacy, and security of drugs, biologics, veterinary products, and medical devices, as well as the safety and security of foods, dietary supplements, cosmetics, and radiological products. 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 medical research and communicate with stakeholders about complex scientific and public health issues. The collaborative development of research, education, and outreach partnerships across FDA products centers with the NORD will greatly contribute to FDA’s mission.
National Organization for Rare Disorders
NORD, a 501(c)(3) organization, is a patient advocacy organization dedicated to individuals with Rare Disorders and the organizations that serve them. NORD, along with its more than 260 patient organization members, is committed to the identification, treatment, and cure of rare disorders through programs of education, advocacy, research, and patient services. NORD has served as the hub of the rare disease community, leading efforts to connect patients and patient organizations with other stakeholders and driving progress for all.
III. Substance of Understanding
FDA’s Patient Affairs Staff, Office of Medical Products and Tobacco, may collaborate with NORD to:
A. Conduct outreach to enhance patients experiences through mutually agreed approaches, including public scientific workshops, training events, listening sessions, and other special venues such as FDA and European Medicines Agency Patient Engagement Cluster; Patient Engagement Collaborative; Patient Reported Outcomes; Patient Focused Drug Development Initiative; Device Patient Preference Initiative; Patient Engagement Advisory Committee;
B. Disseminate FDA Public Health Alerts through web links;
C. Encourage patient participation in the FDA medical product development processes, medical product advisory committees and panels;
D. Have access to patient clinical and medical product consumption experiences, consistent with applicable law;
E. Provide publicly available content to be used in patient informational, educational, and training programs, and
F. Enhance and broaden opportunities to educate and communicate with rare disease patient communities about product safety issues and reporting of adverse events through FDA adverse-event reporting systems.
IV. General Provisions
A. U.S. Federal law governs 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. Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements or to the extent such disclosure is permitted by law.
C. This MOU does not grant exclusivity to either Party, nor does it restrict FDA or NORD from participating in similar initiatives with other public or private agencies, organizations or individuals.
D. FDA and NORD will collaborate to identify specific, preventable medication risks and explore and assess cross-sector interventions. When appropriate, these collaborations may include other partners who are committed to the safe use of human drugs and therapeutic biologics.
E. FDA and NORD recognize that this MOU is not intended to, and may not be relied on to create any right or benefit, substantive or procedural, enforceable by law by any party against the United States or NORD. Nothing in this MOU alters the statutory authorities or obligations of FDA.
F. All materials and programming produced pursuant to this collaboration must be accessible by and free of cost to the public.
G. 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, Pub. L. No. 105-220, Aug. 7, 1998 (see U.S. Department of Health and Human Services policy on Section 508 compliance; and Office of Management and Budget policies for protecting private information.
H. NORD agrees that content provided to NORD by FDA about the collaboration shall be public domain material and as such, FDA shall have full rights to reuse such content for all FDA purposes and the right to share with other collaborators or requestors.
I. FDA retains the right to review all materials produced through this collaboration prior to NORD's public distribution or posting of such materials, and the right to prohibit the public distribution or posting of such materials.
J. NORD will include the following disclaimer language in a clearly distinguishable manner on any web pages on which FDA Health Information provided by FDA is placed pursuant to this MOU: "Information provided by FDA and/or its employees on this website is for educational purposes only, and does not constitute medical advice. Any statement or advice given by an FDA employee on this web site does not represent the formal position of FDA. FDA and/or any FDA employee will not be liable for injury or other damages resulting to any individuals who view FDA-related materials on this website." FDA reserves the right to modify this disclaimer language.
K. FDA and NORD will cooperate in the maintenance of each party's trademarks and logos. NORD agrees that it will not use any FDA logos for marketing purposes other than to promote activities engaged in pursuant to this agreement. The use of FDA names and logos shall not imply any exclusive arrangement. Use of FDA logos must adhere to published FDA logo policies.
L. 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 NORD'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 NORD for use in the collaboration shall in all cases remain solely owned by NORD, as applicable, and no license to use such information is granted under this MOU.
V. Resource Obligations:
Sources of support for 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. NORD is not being compensated by FDA 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 FDA and NORD operate.
VI. Contacts
A. Food and Drug Administration
Andrea Furia-Helms
Acting Director, Patient Affairs Staff
Office of Medical Products and Tobacco
301-796-8455
andrea.furia@fda.hhs.gov
B. National Organization for Rare Disorders
Alexa Moore
Vice President of Development and Marketing
National Organization for Rare Disorders
617-934-6397
amoore@rarediseases.org
VII. Limitations on Liability
In no event, will any party hereto be liable to the other under any theory of liability, however arising, for any costs or cover or for indirect, special, incidental, or consequential damages of any kind arising out of this MOU. The provision shall survive termination, cancellation or expiration of this MOU or any reason whatsoever.
VIII. Term, Termination, and Modification
This MOU, when accepted by all Parties, will have an effective period of performance from the date of the latest signature until three years and may be modified or terminated by mutual written consent by both Parties. Any party may terminate the agreement at any time, but such Party should provide 60-day advance written notice to the other Parties of such termination.
By signing below, the Parties accept the conditions that accurately represent the understanding reached between them.
Approved and Accepted for the Food and Drug Administration
Scott Gottlieb, M.D.
Commissioner of Food and Drugs
U.S. Food and Drug Administration
Department of Health and Human Services
February 20, 2018
Approved and Accepted for the National Organization for Rare Disorders
Peter L. Saltonstall
President and CEO
National Organization for Rare Disorders
February 21, 2018