MOU 225-19-024
MOU 225-19-024 has been amended, effective January 31, 2022.
Memorandum of Understanding
Between
U.S. Department of Health and Human Services
Food and Drug Administration
Office of Surveillance and Epidemiology
and
National Council for Prescription Drug Programs
I. Purpose
This Memorandum of Understanding (MOU) defines the framework for collaboration between the Food and Drug Administration (FDA), Office of Surveillance and Epidemiology (OSE), and the National Council for Prescription Drug Programs (NCPDP). FDA and NCPDP share interests in promoting progress in the exchange of healthcare information to improve patient safety by sharing information related to medication error prevention, pharmacovigilance, and risk evaluation and mitigation strategies (REMS) and related implementation in these areas. The purpose of the collaboration is to improve the safety of the American public when using FDA‐regulated medical products. This MOU establishes the terms for collaboration to promote these shared interests.
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 with the NCPDP will greatly contribute to FDA’s mission.
National Council for Prescription Drug Programs
Founded in 1977, the National Council for Prescription Drug Programs (NCPDP) is a not-for-profit, multi-stakeholder forum for developing and promoting industry standards and business solutions that improve patient safety and health outcomes, while also decreasing costs. The work of the organization is accomplished through its members who bring high-level expertise and diverse perspectives to the forum.
NCPDP creates and promotes standards for the transfer of data to and from the pharmacy services sector of the healthcare industry. NCPDP creates national standards (NCPDP Standards) for real-time, electronic exchange of healthcare information. Our primary focus is on information exchange for prescribing, dispensing, monitoring, managing and paying for medications and pharmacy services crucial to quality healthcare and patient safety. The organization provides a forum and support wherein our diverse membership can efficiently and effectively develop and maintain these standards through a consensus building process. NCPDP also offers its members resources, including educational opportunities and database services, to better manage their businesses.
NCPDP provides a forum and marketplace for a diverse membership focused on healthcare and pharmacy business solutions for, but not limited to, the pharmacy services sector of healthcare.
III. Authority
This MOU is authorized pursuant to section 1003 of the Food, Drug and Cosmetic Act (“the Act”) (21 USC § 393) and 301(a) of the Public Health Services Act (42 USC § 241(a).
IV. Substance of Understanding
FDA and NCPDP may collaborate to do the following:
A. Provide input on NCPDP Standards as they relate to medication error prevention, pharmacovigilance and REMS;
B. Allow FDA participation in relevant NCPDP workgroups; Enhance knowledge of current best practices or practice guidelines in specific care settings on how certain elements of REMS are integrated in the setting of care;
C. Learn how healthcare providers implement different elements of REMS programs, how these programs are integrated in a health care setting, as well as burden associated with supporting these interactions;
D. Collaborate with NCPDP for implementation or modification of REMS programs;
E. Explore opportunities to collaborate on research and training;
F. Explore and convene joint meetings for education and research;
G. Enhance both parties’ scientific understanding on emerging science and pioneering technologies; and
H. Provide publicly available content to be used in health care professional informational, educational, and training programs.
V. 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 NCPDP from participating in similar initiatives with other public or private agencies, organizations or individuals.
D. FDA and NCPDP will collaborate to improve REMS and enhance their integration into healthcare IT systems. When appropriate, these collaborations may include other partners who are committed to the safe use of human drugs and therapeutic biologics.
E. FDA and NCPDP 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 NCPCP. Nothing in this MOU alters the statutory authorities or obligations of FDA.
F. 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 at DHHS: Section 508; and Office of Management and Budget policies for protecting private information at M-03-22, OMB Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.
G. NCPDP agrees that content provided to NCPDP 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.
H. FDA retains the right to review all materials produced through this collaboration prior to NCPDP’s public distribution or posting of such materials, and the right to prohibit the public distribution or posting of such materials.
I. NCPDP 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."
J. FDA and NCPDP will cooperate in the maintenance of each party's trademarks and logos. NCPDP 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. Any use of FDA logos must be submitted in advance to FDA's Safe Use Initiative, who as the point of contact for FDA will seek the appropriate approvals. Following approval, use of FDA logos must adhere to published FDA logo policies (see FDA Logo Policy). Any use of NCPDP logos must be submitted in advance to NCPCP’s Government Affairs Department, who as the point of contact for NCPDP will seek appropriate approvals.
K. 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 NCPDP’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 NCPDP for use in the collaboration shall in all cases remain solely owned by NCPDP, as applicable, and no license to use such information is granted under this MOU.
VI. Resource Obligations:
Sources of support for projects under this MOU will be governed by applicable law, 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 or any required compensation. As specific projects are developed, details of how costs are to be shared will be agreed to in advance under other contractual mechanisms as appropriate and in compliance with all applicable federal requirements. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. 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 NCPDP operate.
VII. Contacts
A. Food and Drug Administration
Principal‐Liaison
Claudia Manzo, Director
Office of Medication Error Prevention and Risk Management
Office of Surveillance and Epidemiology Center for Drug Evaluation Research
10903 New Hampshire Avenue
Building 22
Phone: 301‐796‐0812
E‐mail: Claudia.Manzo@fda.hhs.gov
B. National Council for Prescription Drug Programs
Lee Ann Stember
President and CEO, NCPDP
National Council for Prescription Drug Programs
Phone: 480-477-1000 ext. 108
Email: lstember@ncpdp.org
VIII. 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.
IX. 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 Party 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
Claudia Manzo, Director
Office of Medication Error Prevention and Risk Management
Office of Surveillance and Epidemiology Center for Drug Evaluation Research
/s/
May 29, 2019
Approved and Accepted
for the National Council for Prescription Drug Programs
Lee Ann Stember
President and CEO, NCPDP
National Council for Prescription Drug Programs
/s/
June 17, 2019
MOU 225-19-024 Amendment Number 1
MEMORANDUM OF UNDERSTANDING
BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
U.S. FOOD AND DRUG ADMINISTRATION
OFFICE OF SURVEILLANCE AND EPIDEMIOLOGY
AND
NATIONAL COUNCIL FOR PRESCRIPTION DRUG PROGRAMS
This is amendment number one (1) to the Memorandum of Understanding (MOU) 225-19-024 between the U.S. Department of Health and Human Services, Food and Drug Administration, Office of Surveillance and Epidemiology, and National Council for Prescription Drug Programs (NCPDP).
The purpose of this amendment is to extend the expiration date from June 17, 2019. This is permissible under Section IX—Term, Termination, and Modification. Execution of this amendment provides continuity to promote collaboration and enhance knowledge and efficiency by providing for the sharing of information of mutual concern between the Parties. All other content, terms, and conditions stated in MOU Number 225-19-024, executed on June 17, 2019 will remain unchanged.
This agreement, when accepted by the undersigned, will be effective from the date of the last signature and may be modified or terminated by mutual written consent by both parties or may be terminated by either party upon a thirty- day advance written notice to the other.
APPROVED AND ACCEPTED BY:
U.S. FOOD AND DRUG ADMINISTRATION
Janet Woodcock, M.D., Acting Commissioner of Food and Drugs
U.S. FOOD AND DRUG ADMINISTRATION
/s/
January 31, 2022
APPROVED AND ACCEPTED BY:
NATIONAL COUNCIL FOR PRESCRIPTION DRUG PROGRAMS (NCPDP)
Lee Ann Stember, President and CEO
National Council for Prescription Drug Programs
/s/
January 13, 2022