MOU 225-11-0017 has been amended, effective August 12, 2021.
MEMORANDUM OF UNDERSTANDING
BETWEEN U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
AND INSTITUTE FOR SAFE MEDICATION PRACTICES
(each a "Party" and collectively the "Parties")
This Memorandum of Understanding (MOU) defines the framework for collaboration between the U.S. Food and Drug Administration (FDA) and the Institute for Safe Medication Practices (ISMP). FDA and ISMP share interests in promoting public health through the exchange of scientific information, including product use/medication errors, product problems, risk mitigation strategies, adverse event reporting, education, training, and research. The purpose of the collaboration is to improve product safety to protect the American public when using FDA-regulated products. This MOU establishes the terms for collaboration to promote these shared interests.
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. 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 ISMP will greatly contribute to FDA’s mission.
ISMP is the nation’s first 501c(3) nonprofit organization devoted entirely to preventing medication errors. ISMP is known and respected for its medication safety information and advocacy. For more than 25 years, it also has served as a vital force for progress.
Among its many initiatives, ISMP runs a national voluntary practitioner medication error reporting program, publishes newsletters with real-time error information read and trusted throughout the global healthcare community, and offers a wide range of unique educational programs, tools, and guidelines. In 2020, ISMP formally affiliated with the Emergency Care Research Institute (ECRI) to
create one of the largest healthcare quality and safety entities in the world. ECRI and the ISMP Patient Safety Organization (PSO) is a federally certified patient safety organization by the U.S. Department of Health and Human Services.
This MOU is authorized pursuant to section 1003 of the Federal Food, Drug and Cosmetic Act (“the Act”) (21 USC § 393).
IV. Substance of Understanding
FDA and ISMP may collaborate to do the following:
- Explore dissemination of FDA public health and safety information on websites, social media platforms, newsletters, and webinars, as well as through other communication sources;
- Mutually share safety information, including product use/medication errors and adverse event case reports;
- Contribute to, inform, and/or develop continuing education program content and program assessments;
- Explore and convene joint meetings for education and research;
- Explore opportunities to collaborate on research;
- Conduct outreach through mutually agreed approaches, including training activities, meetings, and symposia;
- Provide FDA access to external scientific, clinical, and medical expertise to supplement existing knowledge and experience within FDA;
- Enhance scientific understanding on emerging science and pioneering technologies;
- Enhance knowledge of current best practices, clinical experience, or practice guidelines in various settings and facilities;
- Provide publicly available content to be used in health care professional informational, educational, and training programs; and
- Enhance and broaden FDA's ability to educate and communicate to health care professionals and consumers about product safety issues and reporting of medication/product use errors and adverse events through FDA’s adverse event reporting systems.
V. General Provisions
- 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.
- 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, patient confidential information or confidential commercial 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.
- This MOU does not grant exclusivity to either Party, nor does it restrict the Parties from participating in similar initiatives with other public or private agencies, organizations or individuals.
- FDA and ISMP will collaborate to identify specific, preventable product risks and develop, implement and assess cross-sector interventions. When appropriate and approved by both parties, these collaborations may include other partners who are committed to the safe use of FDA-regulated products.
- ISMP agrees to publicize FDA health information throughout their ConsumerMedSafety.org website. 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 FDA.
- FDA health information will be easily distinguishable from non-FDA content on ISMP web pages. FDA health information placed on ISMP web pages should be clearly identified as FDA information.
- ISMP agrees to provide space for FDA reports in their print publications, either complementing a story or standing alone, in each issue. Consumer and health information related to FDA-regulated products should be clearly identified as FDA information, either complementing a story or standing alone, in each issue of any ISMP printed publication.
- Printed materials and online web pages containing FDA health information provided by FDA 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.
- 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.
- All materials produced pursuant to this collaboration must be accessible by and free of cost to the general public.
- 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://www.usa.gov/webcontent/regs_bestpractices/laws_regs/privacy.shtml.
- ISMP agrees that content provided to ISMP by FDA 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.
- 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.
- ISMP will include the following disclaimer language in a clearly distinguishable manner on any content on which FDA Health Information is placed pursuant to this MOU: "The health and medical information provided by FDA on this website is not intended to take the place of advice or treatment from healthcare professionals. It is also not intended to substitute for the users' relationships with their own health care/pharmaceutical providers.” FDA reserves the right to modify this disclaimer language.
- 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. The use of FDA logos must adhere to published FDA logo policies (see https://www.fda.gov/about-fda/website-policies/fda-logo-policy).
- 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 O 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
All activities undertaken pursuant to this MOU are subject to the availability of personnel, resources, and funds. The MOU does not create binding, enforceable obligations against any Party. 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 and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and ISMP operate.
VII. Contact Points
- U.S. Food and Drug Administration
Lubna Merchant, Deputy Director
Office of Medication Error Prevention and Risk Management (OMEPRM)
Office of Surveillance and Epidemiology (OSE)
Center for Drug Evaluation and Research (CDER)
10903 New Hampshire Avenue
Building 22, Room 4418
PHONE: (301) 796-5162
- Institute for Safe Medication Practices
Michael R. Cohen, President
Institute for Safe Medication Practices
200 Lakeside Drive, Suite 200
Horsham, PA 19044-2321
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 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.
Institute for Safe Medicine Practices
Michael R. Cohen, President
U.S. Food and Drug Administration
Janet Woodcock, M.D., Acting Commissioner