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MOU 225-11-0017

 

MEMORANDUM OF UNDERSTANDING
BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
AND
INSTITUTE FOR SAFE MEDICATION PRACTICES
(each a "Party" and collectively the "Parties")
 
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 Institute for Safe Medication Practices (ISMP). The purpose of the collaboration is to improve the safety of the American public when using CDER-regulated products through:
 
  •  identifying specific medication risks and developing collaborative activities to help mitigate the risks
  • providing publicly available content to be used in health care professional informational, educational, and training programs. This will enhance and broaden CDER's ability to educate and communicate to health care professionals and consumers about product safety and efficacy issues.
 
The MOU covers CDER programs and initiatives as well as FDA's "Consumer Updates:" when they are written about products regulated by CDER.
 
II. Background

The Center for Drug Evaluation and Research promotes and protects public health by ensuring that safe and effective drugs are available to Americans. CDER evaluates all new and generic drugs prior to entering the market and serves as a consumer watchdog for the more than 10,000 currently marketed drugs to ensure they continue to maintain approved standards. In addition, CDER's long term objectives include continuing to protect the public by ensuring the quality and integrity of marketed drug products and promoting 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.
 
CDER is also responsible for advancing the public health by helping to speed innovations that make medicines safer, and more effective and affordable; and by helping the public get the accurate, science-based information they need to use CDER-regulated products to improve their health ("CDER Health Information").
 
The ISMP is a 501 c (3) nonprofit organization devoted to medication error prevention and safe medication use. ISMP has over 30 years of experience in helping health care professionals keep patients safe, and continues to lead efforts to improve the medication use process.
 
ISMP's initiatives to improve the medication use process, built upon a non-punitive approach and system-based solutions, fall into five key areas: knowledge, analysis, education, cooperation and communication. Through its online portals and mobile applications, ISMP offers health care professionals and patients a variety of information resources and services. ISMP is also certified as a Patient Safety Organization (PSO) by the Agency for Healthcare Research and Quality.
 
III. Authority

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

IV. Substance of Understanding
 
CDER will work with ISMP, as applicable, to define approaches to reduce preventable harm and to facilitate the dissemination of CDER Health Information, including development of web links, continuing medical education (CME) program content and CME program assessment. As part of this effort, CDER and ISMP will identify CDER public health and product alerts, guidance, service descriptions and educational programs for health care professionals and the public.
 
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. Access to non-public information shall be governed by separate Confidentiality Disclosure Agreements in which the Parties will agree and certify in writing that they shall not further release, publish or disclose such information and that they shall protect such information. in accordance with the provisions of 21 U.S.C. 331 (j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, and other pertinent laws and regulations governing the confidentiality of such information. No proprietary data, trade secrets or patient confidential information shall be disclosed among the Parties unless permitted by the provisions of 21 U.S.C. 331 (j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, and other pertinent laws and regulations governing the confidentiality of such information. applicable law.

C. This MOU does not grant exclusivity to either Party, nor does it restrict CDER or ISMP from participating in similar initiatives with other public or private agencies, organizations or individuals.
 
D. CDER and ISMP will collaborate to identify specific, preventable medication risks and develop, implement 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. ISMP agrees to promote the CDER Health Information throughout their ConsumerMedSafety.org web site. Through this online portal, mobile applications and print publications, ISMP will offer consumers and health care professionals information resources and communications services. ConsumerMedSafety.org will feature "Consumer Update" articles, videos and photo slideshows on products regulated by CDER.
 
F. CDER Health Information will be easily distinguishable from non-FDA content on ISMP web pages. CDER Health Information placed on ISMP web pages should be clearly identified as CDER or FDA information. 
 
G. ISMP agrees to provide space for CDER reports in their print publication - Safe Medicine, either complementing a story or standing alone, in each issue. Drug-related consumer and health information should be clearly identified as FDA information, either complementing a story or standing alone, in each issue of the ISMP's printed publication, Safe Medicine.
 
H. Printed materials and online web pages containing CDER Health Information provided by CDER pursuant to this MOU must be free of advertisements, and otherwise must avoid implying FDA's endorsement or support for a particular product, service or website.
 
I. FDA and ISMP 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 ISMP. Nothing in this MOU alters the statutory authorities or obligations of FDA.
 
J. All materials and programming produced pursuant to this collaboration must be accessible by and free of cost to the general public.
 
K. 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 http://ww.hhs.gov/web/508/; and Office of Management and Budget policies for protecting private information at http://ww.usa.gov/webcontent/regs_bestpractices/laws_ regs/privacy.shtml.
 
L. ISMP agrees that content provided to ISMP by CDER in connection with 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.
 
M. ISMP agrees to maintain current CDER Health Information within their web pages. CDER Health Information must be removed from ISMP websites in the following circumstances: (1) within three years of the date of its first publication, unless an extension of a definite term is agreed to by FDA in advance of expiration of the three year period; (2) upon termination of this MOU, if the MOU terminates less than three years after the material is posted; (3) upon FDA's request in circumstances in which the information becomes outdated; or (4) as soon as is commercially practicable but no longer than 72 hours after receipt of FDA's written request to remove the material, regardless of reason. ISMP's failure to display current information or to remove information in accordance with this MOU may result in termination of this MOU and related activities.
 
N. FDA retains the right to review all materials produced through this collaboration prior to ISMP's public distribution or posting of such materials, and the right to prohibit the public distribution or posting of such materials.
 
O. ISMP will include the following disclaimer language in a clearly distinguishable manner on any web pages on which CDER Health Information provided by CDER 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.
 
P. CDER and ISMP will cooperate in the maintenance of each party's trademarks and logos. ISMP 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 CDER's Safe Use Initiative, who as the point of contact for CDER, 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).
 
Q. 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 ISMP's ability to display the FDA logos subject to the restrictions specified under Paragraph J above. For avoidance of doubt, any intellectual property including, without limitation, content, products, technology, data and other information, provided by ISMP for use in the collaboration shall in all cases remain solely owned by ISMP, 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 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. ISMP 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 ISMP operate.
 
VII. CONTACT POINTS
 
A. Food and Drug Administration
Cindi Fitzpatrick, Project Manager
Office of the Center Director, Safe Use Initiative
Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Building 51, Room 1342
PHONE: 301-796-3115 FAX: 301-595-7835
Cynthia.Fitzpatrick@fda.hhs.gov   
   
B. Institute for Safe Medication Practices
Allen Vaida, Executive Vice President
Institute for Safe Medication Practices
200 Lakeside Drive, Suite 200
Horsham, PA 19044-2321
PHONE: 215-947-7797 FAX 215-914-1492
avaida@ismp.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
Signed by: Janet Woodcock, M.D.
Director, Center for Drug Evaluation and Research
U.S. Department of Health and Human
    Services
Date: August 18, 2011
Approved and Accepted
for the Institute for Safe Medication Practices
Signed by: Michael, R. Cohen, President
Institute for Safe Medicine Practices
Date: August 23, 2011
 
 
MEMORANDUM OF UNDERSTANDING
BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
AND
INSTITUTE OF SAFE MEDICATION PRACTICES
(EACH A “Party” and collectively the “Parties”)
 
 
This is an amendment to the Memorandumof Understanding(MOU Number 225-11-0017) to extend agreementfrom August 23, 2014 to indefinitely. The time extension is permissibleunder Article X titled, "Terms, Termination,and Modification."
 
The purpose of the collaborationis to improve the safety of the American public when using COER-regulated products through:
 
-    identifying specific medication risks and developing collaborative activities to help mitigate the risks
 
-    providing publicly available content to be used in health care professional informational, educational, and training programs. This will enhance  and
     broaden CDER's ability to educate and communicate to healthcare professionals and consumers about product safety and efficacy issues.
 
The MOU covers CDER programs and initiatives as well as FDA's "Consumer Updates" when they are written about products regulated by CDER.
All other content of the MOU Number 225-11-0017 executed on August 23, 2011, remains unchanged.
 
APPROVED AND ACCEPTED
FOOD AND DRUG ADMINISTRATION
 
Janet Woodcock, M.D.         
Director, Center for Drug Evaluation and Research
 
July 17, 2014
 
 
APPROVED AND ACCEPTED
INSTITUTE OF SAFE MEDICATION PRACTICES
 
Michael R. Cohen
President, Institute of Safe Medication Practices
 
July 2, 2014