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U.S. Department of Health and Human Services

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MOU 225-12-0016


I.  Purpose
This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote shared interests between the United States Food and Drug Administration (FDA) and ImproveCareNow.
The FDA and ImproveCareNow share interests in improving disease outcomes of children with Crohn’s disease and ulcerative colitis. Achieving this common goal may be facilitated through a collaborative working relationship. Both parties foresee benefits from the exchange of information on medication safety. In addition, the FDA can provide ImproveCareNow members training on reporting of medication-related adverse events. ImproveCareNow also collects efficacy outcome information which may be an important data resource for FDA with regard to practice patterns in uses of specific medications and dose response.

This MOU and the collaborative framework it provides will facilitate consensus development between the parties and establish the terms for collaboration to promote the shared interests, which include safety reporting, collaborative research, and educational initiatives. 
II.  Background
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301). In fulfilling its responsibilities under the Act, FDA among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products and the safety and security of foods and cosmetics. 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 patient care and communicate with stakeholders about complex scientific and public health issues.  Therefore, increased collaboration with organizations who perform research, education, and outreach, such as the ImproveCareNow organization, is complementary to FDA’s mission.

The mission of ImproveCareNow, as a learning health system, is to improve the care and outcomes of children with Crohn’s disease and ulcerative colitis. ImproveCareNow strives to use quality improvement methods to ensure that children with inflammatory bowel disease (IBD) are treated in an evidence-based manner with consistent reliable care; identifies clinically-oriented questions for which current evidence is lacking; and collects/analyzes data to facilitate clinical care, quality improvement and clinical research.

The Network’s goals are: 

1.  To increase the remission rate, prednisone-free remission rate, and sustained remission rate, while reducing the rate of prednisone use and improving nutritional and growth status 

2.  To have highly reliable monitoring of disease severity, nutrition and growth, and to optimize the use of medications 

3.  To establish and maintain a full population registry with high quality data 

4.  To utilize population management, previsit planning and self-management support to improve care and outcomes 

5.  To monitor, learn from and prevent serious adverse events 

To utilize the ImproveCareNow database for discovery, new knowledge and the application of new knowledge 

7.  To create and maintain a patient- and family-centered Collaborative Chronic Care Network in which patients, families, clinicians, researchers and improvement scientists communicate effectively and innovate together 

8.  To create a learning health system by implementing innovations in informatics, patient-reported outcomes and patient confidentiality that automate and enhance care, improvement and research while reducing transactional costs 

9.  To add value to care 

The Improve Care Network is currently made up of 33 centers with 300 pediatric gastroenterologists and 10,000 patients with Crohn’s disease and ulcerative colitis. The Network has been growing by about 6 centers annually. 
III.  Substance of Agreement

This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives, and intellectual partnerships between FDA and ImproveCareNow.  The types of initiatives expected to develop from this MOU include the following:

1.  Increased and more comprehensive reporting of adverse reactions to medications through training on MedWatch reporting, and discussions and updates on specific adverse reactions of interest

2.  Educational initiatives regarding safety reporting

3.  Development of systems to facilitate ongoing long-term safety evaluation of children as they transition from pediatric gastroenterology network care to adult gastroenterology care

4.  Analyses of practice patterns in uses of specific medications and dose response

5.  Joint publications and pronouncement of working relationship on specific initiatives

Under this MOU, joint efforts will be undertaken to support enhanced safety reporting, collaborative research, and educational initiatives as permitted under appropriate statutory authority.  Before any specific collaboration is initiated or implemented, the Parties shall identify priorities, topics of mutual interest, and develop separate, written agreements for collaboration and sharing of resources.  Where applicable, these agreements shall incorporate this MOU by reference.  The terms and conditions of any such agreements will comply with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within ImproveCareNow and FDA.

IV. General Provisions

1.  Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.

2.  ImproveCareNow and FDA may decide to enter Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects.  The terms of such CRADAs will address Intellectual Property rights.

3.  Proprietary 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. 

4.  Each Party will comply with the other Party's security procedures and policies regarding access to and use of facilities.  Either Party may restrict or limit access to its property and facilities for any reason.  ImproveCareNow individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.

5.  As research projects are developed, details will be agreed to in advance under other agreements as appropriate. 

V. Resource Obligations 

This MOU represents the broad outline of the FDA and ImproveCareNow’s intent to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to available resources. It does not create binding, enforceable obligations against any Party. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU.  

VI. Liaison Officers
FDA's Center for Drug Evaluation and Research (CDER) is the lead center for this MOU.  The individual to whom all inquiries toFDA should be addressed is: 
Name:  Donna J. Griebel, MD
Address:  White Oak Building 22, room 5112
Telephone:  301-796-4153
e-mail:  donna.griebel@fda.hhs.gov

The individual(s) to whom all inquiries to Institutions within ImproveCareNow should be addressed is: 
Name:  Richard B. Colletti, MD
Address:  N-213 Given Courtyard
                UVM College of Medicine
                Burlington VT 05405-0068
Telephone:  802-656-2296
Fax:  802-656-2077
Each Party may designate new liaisons by notifying the other Party's liaison in writing. If an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Parties will name a new liaison within two weeks and notify the other Party through the designated administrative liaison. 
VII. Term, Termination, and Modification
This agreement becomes effective upon acceptance by both Parties and will continue in effect for five (5) years. It may be renewed by mutual written agreement of both Parties. It may be modified by the mutual written agreement of both Parties. It may be terminated by either Party upon 60-day advance written notice to the other. 
VIII. Statutes, Regulations, Rules, and Policies

This MOU and all associated agreements will be subject to the applicable statutes, regulations, rules, and policies under which FDA and the ImproveCareNow operate.

Approved and Accepted
for ImproveCareNow
Signed by: Richard B. Colletti, M.D.
President, ImproveCareNow
Date: April 4, 2012
Approved and Accepted
for the Food and Drug Administration
Signed by: Janet Woodcock, M.D.
Director, CDER, FDA
Date: April 5, 2012