The United States Food and Drug Administration (FDA) and The University of Hawaii share interests in promoting scientific progress through exchange of scientific capital in public health, epidemiology and pharmaceutical sciences. This Memorandum of Understanding (MOU) forms the basis for the initial relations between FDA and the University of Hawaii, College of Pharmacy (UHCP) for sabbaticals, research and scientific education.

 

 

FDA identified the strategic goal to expand agency efforts to meet the needs of special populations. FDA supports the premise that therapeutic breakthroughs and clear and timely public health information should be available to all Americans. There are numerous challenges to achieving this goal.  For example, historically ethnic and racial minorities have been underrepresented in clinical trials, making it difficult to assess whether a medical product will be safe and effective for them. Assuring that products are safe and effective for people with rare diseases is challenging, because the patient populations are too small to support standard clinical trials. FDA is committed to reducing this risk through targeted scientific programs and culturally sensitive outreach efforts.

 

The Office of Minority Health (OMH) advances FDA's regulatory mission in addressing the reduction of racial and ethnic health disparities and in achieving the highest standard of health for all. The Office provides leadership and direction in identifying agency actions that can help reduce health disparities, including the coordination of efforts across the Agency. The Office of Minority Health serves as the principal advisor to the Commissioner on minority health and health disparities.

 

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, 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, dietary supplements, 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 research and communicate with stakeholders about complex scientific and public health issues. Increased development of research, education and outreach partnerships within the University of Hawaii Hilo will contribute to FDA's mission.

 

The University of Hawaii Hilo is a public and co-educational institution. The University is composed of six Colleges, and has received recognition for numerous academic programs including the marine biology, volcanology, astronomy, Hawaiian language, pharmacy, agriculture, computer science, and nursing programs. The MOU focuses on collaborations with the College of Pharmacy. The vision of the College of Pharmacy at the University of Hawaii Hila is to drive improvement of healthcare in Hawaii and throughout the Pacific. The mission is to educate pharmacy practitioners and leaders, to serve as a catalyst for Innovations and discoveries in pharmaceutical science and practice for promoting health and wellbeing, and to deliver quality patient care.

 

 

This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives between FDA and UHCP to explore health disparities in regulatory science. The types of initiatives expected to develop from this MOU include:

 

1. Opportunity to apply for a joint fellowship program at the FDA to advance student and faculty education. One of the mechanisms to enroll students/post-doctoral trainees/residents from the University of Hawaii into the joint fellowship program at the FDA is through the CDER Oak Ridge Institute for Science and Education (ORISE) fellowship program. If prospective fellows or faculty enter the program through the ORISE fellowship mechanism, the Office of Minority Health and UHCP will adhere to the CDER arise Fellowship rules and regulations. Fellows or faculty members entering the program must agree to the ORISE terms of appointment which will be outlined in an offer of appointment letter;

2. Advancing student education and matriculation into pharmacy science professions;

3. Opportunities for faculty training in the regulatory science pathways;

4. Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;

5. Opportunities to convene joint meetings for education and research; and

6. Research and evaluation collaborations.

 

Under this MOU, FDA and UHCP will seek opportunities to participate together in collaborative health disparities research and training as permitted under appropriate statutory authority.  In particular, collaboration will rely upon UHCP's research expertise in working with Asian American, Native Hawaiian and Pacific Islander populations to further knowledge of health disparities in regulatory science.  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 by reference this MOU. FDA may enter supplemental agreements with UHCP to the extent authorized by law and available appropriations. The terms and conditions of any such agreements will be compliant with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within UHCP and FDA.

 

 

a. Confidentiality -- 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 applicable law

 

b. Conflict of Interest -- Participants in activities under this MOU who are not U.S. Government employees will be expected to abide by conflict of interest rules and policies as specified by FDA. This may require participants to disclose their financial holdings and those of their spouse and minor children, and may limit their ability to accept gifts and have employment with entities that are substantially regulated by FDA. The Parties will be advised of any potential conflict so conflicting assignments can be avoided consistent with the HHS/FDA requirements. If before or while performing the activities under the MOU, the Parties believe that a potential or actual conflict exists, the Parties must notify the appropriate authorities within their respective institutions and, in the case of UHCP, shall contact the designated FDA officials listed on the MOU so the necessary actions can be undertaken. A determination will be made by FDA on whether a conflict of interest exists and how to resolve or mitigate it.  Parties to the MOU will avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions.

 

c. Intellectual Property Rights - Institutions within University of Hawaii and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.

 

d. Security- 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 at any time and for any reason. University of Hawaii individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.

 

e. As research projects are developed, details will be agreed to in advance under other agreements as appropriate and in compliance with all applicable federal requirements.

 

 

This MOU represents the broad outline of the FDA and UHCP's intent to collaborate in areas of mutual interest. It does not create binding, enforceable obligations against any Party.  All activities that may be undertaken by this MOU are subject to available personnel and resources. 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. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and UHCP operate.

 

VI. Liaison Officers:

 

The individual to whom all inquiries for UHCP should be addressed is:

 

A. For the College of Pharmacy, University of Hawaii at Hilo

Individual's name: Robert P. Borris, PhD

Organization: College of Pharmacy, University of Hawaii at Hilo

Title: Associate Dean for Research

Address: 34 Rainbow Drive, Hilo, HI 96720

Telephone Number: (808) 981-8001

Email Address: [email protected]

 

FDA's Office of Minority Health is the lead for this MOU. The individual to whom all inquiries for FDA should be addressed is:

 

B. For the Food and Drug Administration:

Individual's name: Jonca Bull, M.D.

Organization: Office of Minority Health

Title: Director

Address: 10903 New Hampshire Avenue, Silver Spring, MD 20993

Telephone Number: (301) 796-8000

Email Address: Jonca.Bull@fda.hhs.gov

 

Each Party may designate new liaisons by notifying the other Party's liaison officers in writing.  If an individual designated as a liaison under this agreement becomes unavailable to fulfill his or her functions, the Parties will name a new liaison within 2 weeks and notify the other Party through the designated administrative liaison.

 

 

This agreement will be effective when accepted by all participating parties. This agreement may be modified or terminated by mutual written consent by both parties or may be terminated by either party upon a 60-day advance written notice to the other.

 

Approved and Accepted
for University of Hawaii, College of Pharmacy
Signed by: Robert P. Borris, Ph.D.
Associate Dean for Research and Associate Professor
Date: March 30, 2012

 

Approved and Accepted
for the Food and Drug Administration
Signed by: Jesse Goodman, M.D., MPH
Chief Scientist and Deputy Commissioner for Science and Public Health
Date: March 22, 2012