MOU 225-16-015
MEMORANDUM OF UNDERSTANDING
BETWEEN THE FOOD AND DRUG ADMINISTRATION,
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND THE OFFICE OF THE U.S. GLOBAL AIDS COORDINATOR,
U.S. DEPARTMENT OF STATE
I. Purpose
The purpose of this Memorandumof Understanding (MOU) is to establish a framework for enhanced cooperative efforts, including information-sharing efforts, between the Office of the U.S. Global AIDS Coordinator, U.S. Departmentof State (OGAC) and the Food and Drug Administration, U.S. Department of Health and Human Services (FDA) (together, the Participants) to ensure the safety, efficacy, and quality of medical products regulated by FDA and procured for the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), a program managed by OGAC.
II. Background
FDAis authorized to enforce the Federal Food,Drug,and Cosmetic Act (the Act) as amended (21U.S.C. § 301et seq.). In fulfilling its responsibilities under the Act, FDA directs its activities toward, among other things, promoting and protecting the public health by assuring the safety, efficacy, and security of drugs,veterinary products, and medical devices; and the safety and security of foods, dietary supplements, cosmetics and radiologicalproducts. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products.
FDA ensures the availability of safe,effective,and quality antiretroviral drugs to meet the in-country treatment goals of global agencies and governments engaged in the treatment
and care of patients living with HIVIAIDS. Using a process that combines focused engagement with companies prior to submitting authorization packages and the "expedited review" determination, FDA approves or tentatively approves single-entity, fixed-dose combination, and co-packaged versions of previously-approved antiretrovirals (most of which are still protected in the United States by patent and/or exclusivity) to increase the arsenal of low-cost, high-quality HIV/AIDS therapies available for purchase under PEPFAR. By making these much-needed, high-quality generic products available for registration and marketing in PEPFAR focus countries,FDA has significantly reduced the cost of treatment and helped save lives.
OGAC's mission is to lead implementationof PEPFAR. OGAC leads the U.S. government's international HIVIAIDS efforts; ensures program and policy coordinationamong the relevant USG agencies and departments and nongovernmental organizations, avoiding duplication of effort; reimburses FDA for the cost of reviewing a New Drug Application for PEPFAR products; pursues coordination with other countries and international organizations; resolves policy, program, and funding disputes among the relevant USG agencies and departments; directly approves all activities of the United States relating to combating HIV/AIDS in focus countries; and promotes program accountability and monitors progress toward meeting PEPFAR's goals.
FDA occasionally has the need toshare certain non-public information acquired during its regulatory activities with OGAC, whether proactively or in response to a request from OGAC. OGAC funds HIV/AIDS treatment for millions of patients globally, and the majority of the patients in PEPFAR programs rely primarily on FDA-approved HIV/AIDS medicines by PEPFAR procurers. Therefore, any FDA regulatory actions relating toPEPFAR medical products that result in disruption in the manufacturing of antiretrovirals may cause drug shortages for PEPFAR programs globally.Given that OGAC interfaces and coordinates PEPFAR activities related to treatmentof HIV/AIDSpatients with USGagencies and partner countries, FDA's informing OGAC of regulatory actions ahead of time may help prevent drug shortages as well as enable PEPFAR implementing agencies to put into place appropriate quality assurance mechanisms for antiretrovirals.There can also be occasions on which FDA's providing non-public information to OGAC in response to a request from OGAC supports the efficient management of PEPFAR.
Ill. General Provisions
A. This is an internal U.S. government MOU between FDA and OGACand does not confer any rights or benefits to any person or either Participant.
B. This MOU represents the Participants' present intent to collaborate in cooperative efforts with OGAC to ensure the safety, efficacy, and quality of medical products regulated by FDA in the context of PEPFAR.
C. All activities undertaken under this MOU are subject to the availability of personnel, resources, and funds.
D. This MOU does not affect or supersede any existing or future agreements or arrangements between the Participants.
E. This MOU does not create binding,enforceable obligations against any person or either
Participant.
F. This MOU is subject to the applicable policies, rules, regulations, and statutes under which FDA and OGAC cooperate.
IV. Sharing Non-Public Information
A. The sharing of non-public information will be in accordance with applicable statutes and regulations.
B. FDA is authorized under 21C.F.R.20.85 to disclose certain non-public information to OGAC regarding FDA-regulated products in reliance on the Confidentiality Agreement signed by OGAC on [April l4,2 016] (Appendix 1).
C. FDA may share such non-public information with OGAC proactively, or OGACmay request non-public information from FDA.
D. OGAC recognizes that FDA may, in light of FDA's practices, priorities, and resources, decide not to provide non-public information to OGAC in response toa request from OGAC.
E. Pursuant to 21U.S.C § 3310),FDA will not reveal to OGAC any method or process which entitled to protection as a trade secret without the written consent of the person with the authority to provide such consent. Furthermore, pursuant to 21U.S.C. § 360j(c), FDA will not reveal to OGAC certain confidential commercial information relating to
medical devices.
F. OGAC recognizes that information exchanged that contains any of the following types of information should be protected from unauthorized use and disclosure: (1) confidential commercial information, such as the information that would be protected from public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA); (2) personal privacy information, such as the information that would be protected from public disclosure pursuant to Exemption 6 or 7(C) of the FOIA; or {3) information compiled for law enforcement purposes and information concerning internal government deliberations that would not be disclosed to the public by FDA, or (4) information that is otherwise protected from public disclosure by federal statutes and their implementing regulations (e.g.,Trade Secrets Act {18 U.S.C. §1905)), the Privacy Act (5 U.S.C.§552a), other FOIA exemptions not mentioned above (5 U.S.C. § 552(b)), the Federal Food, Drug, and Cosmetic Act (21U.S.C. §301et seq.), and the Health Insurance Portability and Accountability Act (Pub. L.104-191).
G. FDA intends to include a transmittal letter with any non-publicinformation shared. A model transmittal letter is attached to this MOU (Appendix 2). In addition,each page of the shared documents containing non-public information should be stamped do not disclose without permission of FDA." If the information is shared orally, by telephone or in meetings, FDA expects to begin discussions with a reminder that the information is confidential and covered by the non-disclosure agreement, with words substantially to the effect of the following: OGAC should consult with FDA prior to release of shared non-public information in response to any attempt by a third party to obtain such information by compulsory process, including, but not limited to, a FOIA request, subpoena, or litigation discovery request.
K. If OGAC receives a FOIA request for shared information, OGAC should refer any shared non-public information retrieved in response to the FOIA request to FDA.
l. Whenever feasible, OGAC should notify FDA before complying with any judicial order that compels the release of shared non-public information, so that the FDA may determine the appropriate measures to take, including, where appropriate, taking legal action.
V. Liaisons
A. For FDA:
FDA PEPFAR liaison
Office of International Programs
B. For OGAC:
Douglas N. Shaffer, MD, MHS, FACP
Chief Medical Officer
Office of the U.S. Global AIDS Coordinator and Health Diplomacy
1800 G Street,N.W.,Suite 10300
Washington,D.C. 20006
Tel: (202) 255-9410
Fax: (202) 663-1089
Email: [email protected]
Each Party may designate new liaisons at any time by notifying the other Party's administrative liaison in writing.
VI. Modification and Termination
The Participants intend that this MOU become effective when accepted by both Participants. The Participants understand that this MOU may be modified or terminated by mutual written consent, or it may be terminated by either Participant upon 60 days' advance written notice to the other.
APPROVED AND ACCEPTED
FOR THE OFFICE OF THE U.S. GLOBAL AIDS COORDINATOR
Douglas N. Shaffer, MD, MHS, FACP
Chief Medical Officer, OGAC
April 14, 2016
APPROVED AND ACCEPTED
FOR THE FOOD AND DRUG ADMINISTRATION
Mary Lou Valdez
Associate Commissioner for International Programs
April 15, 2016
Appendix 1 -- Confidentiality Agreement
Statement of Legal Authority and Commitment from the Office of the U.S. Global AIDS Coordinator U.S. Department of State Not to Publically Disclose Non Public Information Shared by the Food and Drug Administration, U.S. Department of Health and Human Services
This is a confidentiality agreement between the Office of the U.S. Global AIDS Coordinator, U.S. Department of State (OGAC) and the Food and Drug Administration, U.S. Department of Health and Human Services (FDA), signed in conjunction with the (April 14, 2016) Memorandum of Understanding between the Office of the U.S. Global AIDS Coordinator, U.S. Department of State and the Food and Drug Administration, U.S. Department of Health and Human Services (MOU). Under the 21 C.F.R. section 20.85, and pursuant to such a written Confidentiality Agreement, FDA is authorized to disclose certain non-public information exempt from public disclosure under the laws and regulations of the United States, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal , pre-decisional information. OCA understands that this non-public information is shared in confidence, and that FDA considers it critical that OG|AC maintain the confidentiality of the information. Public disclosure of this information by OGAC could seriously jeopardize any further regulatory interactions between FDA and OGAC. FDA will advise OGAC of the non-public information status of shared information at the time that the information is shared, in accordance with section IV.E. of the MOU. Therefore, OGAC certifies that it:
1. will take legally available steps to protect the non-public information provided to OGSAC in confidence by the FDA from public disclosure;
2. will not publically disclose the FDA provided non-public information without the written permission of FDA unless required by law or regulation;
3. will inform FDA promptly of any effort made to obtain FDA-provided non-public information from OGAC by judicial or legislative mandate. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, OGAC will ake all measures legally available in an effort to ensure that the information will be disclosed in a manner that protects the information from public disclosure; and
4. will promptly inform FDA of any changes to U.S. Law or OGAC policies or procedures that would affect OGAC's ability to honor the commitment in this Confidentiality Agreement.
Douglas N. Shaffer, MD, MHS, FACP
Chief Medical Officer
Office of the U.S. Global AIDS Coordinator and Health Diplomacy
1800 G Street. N.W., Suite 10300
Washington, D.C. 20006
Tel: 202-255-9410
Fax: 202-688-1089
Email: [email protected]