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MOU 225‐18‐012

Memorandum of Understanding 
Between U.S. Department of Health and Human Services, Food and Drug Administration, Office of External Affairs, Office of Health and Constituent Affairs
and
American Pharmacists Association 

I.  Purpose 

This Memorandum of Understanding (MOU) defines the framework for collaboration between the Food and Drug Administration (FDA), Office of External Affairs (OEA), Office of Health and Constituent Affairs (OHCA), and the American Pharmacists Association (APhA).  FDA and APhA share interests in promoting scientific progress through exchange of scientific capital in medication error prevention and medication safety including risk evaluation and mitigation strategies (REMS) and related implementation, MedWatch adverse event reporting, scientific education, training and research programs.  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 APhA will greatly contribute to FDA’s mission.

American Pharmacists Association
 
Founded in 1852, APhA is the largest association of pharmacists in the United States, with more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians as members. The American Pharmacists Association strives to lead the pharmacy profession and equip members for their role as the medication expert in team‐based, patient-centered care. APhA intends to accomplish this by:

  • Advancing pharmacists' optimal roles in team‐based, patient‐centered care.
  • Providing opportunities for professional development, recognition, differentiation, and leadership.
  • Disseminating timely relevant information and state‐of‐the‐art tools and resources.
  • Raising societal awareness about the role of pharmacists as essential in patient care for optimal medication use.
  • Creating unique opportunities for members to connect and share with peers across practice settings.

III.  Authority 

This MOU is authorized pursuant to section 1003 of the Food, Drug and Cosmetic Act (“the Act”) (21 USC § 393).

IV.  Substance of Understanding

FDA and APhA may collaborate to do the following:
A. Explore dissemination of FDA Public Health Alerts through web development links;
B.  Contribute to, inform, and/ or develop accredited continuing pharmacist education program content and program assessments;
C. Explore and convene joint meetings for education and research;
D. Explore opportunities to collaborate on research; 
E. Conduct outreach to enhance the visibility of the collaboration through mutually agreed approaches, including training activities, meetings, and symposia;
F. Provide FDA access to external scientific, clinical, and medical expertise to supplement existing knowledge and experience within FDA;
G. Enhance both parties’ scientific understanding on emerging science and pioneering technologies; 
H. Provide FDA access to current external experts’ best practices and clinical experience for safe management of healthcare consumers in various clinical settings and facilities;
I. Enhance knowledge of current best practices or practice guidelines in a specific care settings on how certain elements of REMS are integrated in the setting of care;
J. Enhance knowledge of current clinical experience with dispensing/managing healthcare consumers on specific products that have REMS requirements;
K. Learn how pharmacists 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;
L. Provide publicly available content to be used in health care professional informational, educational, and training programs, and
M. Enhance and broaden FDA's ability to educate and communicate to health care professionals and consumers about product safety issues and reporting of adverse events through FDA’s MedWatch and other adverse‐event reporting systems.

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 APhA from participating in similar initiatives with other public or private agencies, organizations or individuals.
 
D. FDA and APhA will collaborate to identify specific, preventable medication risks. When appropriate, these collaborations may include other partners who are committed to the safe use of human drugs and therapeutic biologics.
 
E. FDA and APhA 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 APhA. 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 at https://www.hhs.gov/web/section508/what‐is‐section‐504/index.html; and Office of Management and Budget policies for protecting private information at
https://obamawhitehouse.archives.gov/omb/memoranda_m03‐22/
 
H. APhA agrees that content provided to APhA 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 APhA’s public distribution or posting of such materials, and the right to prohibit the public distribution or posting of such materials.
 
J. APhA 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.
 
K. FDA and APhA will cooperate in the maintenance of each party's trademarks and logos. APhA 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
http://ww.fda.gov/AboutFOAlAboutThisWebsitelWebsitePolicies/ucm218116.htm). Any use of APhA logos must be submitted in advance to APhA’s Government Affairs Department, who as the point of contact for APhA will seek appropriate approvals.
 
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 APhA’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 APhA for use in the collaboration shall in all cases remain solely owned by APhA, 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. It is recognized that from time to time FDA and APhA may share expenses and may require compensation of either Party by the other.  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 APhA operate.

VII. Contacts

 A.   Food and Drug Administration
Principal Liaison
Heidi C. Marchand
Office of Health and Constituent Affairs Office of External Affairs
10903 New Hampshire Avenue
Building 32
301-796-8457
Heidi.marchand@fda.hhs.gov
 
Co‐Liaison
Lubna Merchant, Deputy Director (Acting)
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: 301‐796‐5162
E‐mail: Lubna.Merchant@fda.hhs.gov
   
B.   American Pharmacists Association
Stacie Maass
SVP, Pharmacy Practice and Government Affairs
American Pharmacists Association
Phone:  202-429-7533
Email: smaass@aphanet.org 

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

Heidi C. Marchand, PharmD
Assistant Commissioner for Health and Constituent Affairs
/s/
April 25, 2018
 
Lubna Merchant, Deputy Director (Acting)
Office of Medication Error Prevention and Risk Management
Office of Surveillance and Epidemiology Center for Drug Evaluation Research
/s/
April 25, 2018
 
Approved and Accepted for the American Pharmacists Association

Stacie Maass
SVP, Pharmacy Practice and Government Affairs
American Pharmacists Association
/s/
April 25, 2018