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MOU 225-18-011

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 SOCIETY OF HEALTH-SYSTEM PHARMACISTS

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 Society of Health-System Pharmacists (ASHP). FDA and ASHP 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 ASHP will greatly contribute to FDA’s mission.

American Society of Health-System Pharmacists

ASHP is a national professional organization whose nearly 40,000 members include pharmacists, pharmacy technicians, and pharmacy students who provide patient care services in hospitals, health systems, and ambulatory clinics. Historically, the Society has been on the forefront of efforts to improve medication use and enhance patient safety. The mission of the pharmacists is to help people achieve optimal health outcomes. ASHP helps its members achieve this mission by advocating and supporting the professional practice of pharmacists in hospitals, health systems, ambulatory care clinics, and other settings spanning the full spectrum of medication use. ASHP serves its members as their collective voice on issues related to medication use and public health.

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 will collaborate with ASHP to do the following:

A. Explore dissemination of FDA Public Health Alerts through web development links.
B. Assist ASHP to determine accredited continuing pharmacist education program content and program assessment opportunities;
C. Explore and convene joint meetings for education and research;
D. Explore opportunities to collaborate on research activities to access scientific, clinical, and medical expertise to supplement existing knowledge and experience within FDA;
E. Conduct outreach to enhance the visibility of the collaboration through mutually agreed approaches, including training activities, meetings, and symposia;
F. Enhance both parties’ understanding on emerging science and pioneering technologies;
G. Access current external experts’ best practices and clinical experience for safe management of healthcare consumers in various clinical settings and facilities;
H. Enhance both parties’ 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;
I. Enhance both parties’ knowledge of current clinical experience with dispensing/managing healthcare consumers on specific products that have REMS requirements;
J. Learn how pharmacists and health-systems 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;
K. Provide publicly available content to be used in health care professional informational, educational, and training programs, and
L. Assist ASHP 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.

ASHP will collaborate with FDA to do the following:

A. Explore dissemination of FDA Public Health Alerts through web development links;
B. Assist ASHP to determine accredited continuing pharmacist education program content and program assessment opportunities;
C. Explore and convene joint meetings for education and research;
D. Explore opportunities to collaborate on research activities to access scientific, clinical, and medical expertise to supplement existing knowledge and experience within ASHP;
E. Disseminate information and conduct outreach to enhance the visibility of the collaboration through mutually agreed approaches, including training activities, meetings, and symposia;
F. Enhance both parties’ scientific understanding on emerging science and pioneering technologies;
G. Share information with FDA on best practices and clinical experience for safe management of healthcare consumers in various clinical settings and facilities;
H. Share information with FDA on current best practices or practice guidelines in a specific care settings on how certain elements of REMS are integrated in the setting of care;
I. Share information with FDA on current clinical experience with dispensing/managing healthcare consumers on specific products that have REMS requirements;
J. Identify specific medication risks and discuss possible ways to mitigate them;
K. Share information with FDA on how pharmacists and health systems 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. Incorporate publicly available FDA content in healthcare professional informational, educational, and training program, and
M. Work with FDA to enhance outreach to healthcare 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 ASHP from participating in similar initiatives with other public or private agencies, organizations or individuals.

D. FDA and ASHP 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 ASHP. Nothing in this MOU alters the statutory authorities or obligations of FDA.

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

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 https://www.hhs.gov/web/section-508/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/

G. ASHP agrees that content provided to ASHP 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 ASHP's public distribution or posting of such materials, and the right to prohibit the public distribution or posting of such materials.

I. ASHP 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 ASHP will cooperate in the maintenance of each party's trademarks and logos. ASHP 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).

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 ASHP'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 ASHP for use in the collaboration shall in all cases remain solely owned by ASHP, 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. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. ASHP 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 ASHP operate.

VII. Contacts

A. Food and Drug Administration
Heidi Marchand
Office of Health and Constituent Affairs Office of External Affairs
10903 New Hampshire Avenue Building 32
PHONE: 301-796-8457
E-mail: heidi.marchand@fda.hhs.gov

Lubna Merchant
Center for Drug Evaluation Research 10903 New Hampshire Avenue Building 22
Phone: 301-796-5162
E-mail: lubna.merchant@fda.hhs.gov

B. American Society for Health Systems Pharmacists
Kasey Thompson
4500 East West Highway, Suite 900
Bethesda, MD 20814
Phone: 301-664-8663
kthompson@ashp.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 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

/S/
Heidi Marchand. Pharm.D.
Assistant Commissioner for Health
and Constituent Affairs

Date: 2/27/18


 /S/
Lubna Merchant, M.S., Pharm.D., Deputy Director
Office of Medication Error Prevention and Risk Management
Center for Drug Evaluation Research

Date: 2/27/18

Approved and Accepted for the American Society for Health System Pharmacists

/S/
Kasey Thompson
Chief Operating Officer
ASHP

Date: 4/26/18