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MOU 225-08-8003

MEMORANDUM OF UNDERSTANDING
BETWEEN THE OFFICE OF THE ASSISTANT SECRETARY OF DEFENSE (HEALTH AFFAIRS),
VETERANS HEALTH ADMINISTRATION,
INDIAN HEALTH SERVICE,
AND THE FOOD AND DRUG ADMINISTRATION

1. PREAMBLE

The Food and Drug Administration (FDA) and Indian Health Service (IHS), as part of the Department of Health and Human Services; the Office of the Assistant Secretary of Defense (Health Affairs), as part of the Department of Defense (DoD), and the Veterans Health Administration (VHA), as part of the Department of Veterans Affairs, all United States Federal Government entities and hereafter also referred to as “Federal partners,” agree to work together to review, discuss, and promote safety initiatives related to the review and use of FDA-regulated drugs, biologics, and medical devices, as defined by the Federal Food, Drug and Cosmetic Act (see 21 U.S.C. 321) and the Public Health Service Act (see 42 U.S.C.262).

2. PURPOSE AND GOALS

The purpose of this Memorandum of Understanding (MOU) is to enhance knowledge and efficiency by providing for the sharing of information and expertise between the Federal partners. The goals of this collaboration are to explore ways to:

a. Further enhance information-sharing efforts through more efficient and robust interagency activities.

b. Promote efficient utilization of tools and expertise for product risk identification, validation, and analysis.

c. Build infrastructure and processes that meet the common needs for evaluating the safety, efficacy, and utilization of drugs, biologics, and medical devices.

3. SUBSTANCE OF THE AGREEMENT

a. Each Federal partner will establish a single Agency liaison to facilitate the actions carried out under this MOU.

b. DoD, VHA, IHS, and FDA agree to attend an initial meeting to establish the specific procedures and safeguards necessary to implement this MOU. The initial meeting will take place within 30 days of signing and approval of this MOU. Periodic meetings will be scheduled thereafter. DoD, VHA, IHS, and FDA agree not to share information under this MOU unless, and until, adequate procedures and safeguards agreed upon by each Federal partner are established and implemented.

c. VHA, DoD, IHS, and FDA agree that each initial request for information will be made by and transmitted to the Agency liaisons designated according to Section 3.a. of this MOU. Subsequent communications pertaining to that issue may occur between other staff as approved by the liaisons.

d. FDA, VHA, IHS, and DoD agree that any Federal partner may decide not to share information or expertise in response to a request for information made according to the procedures established under Section 3.b., or to limit the scope of information and expertise sharing in response to a request. A decision not to share information in response to a specific request may be based on several factors, including, for example, the amount of resources necessary to fulfill the request, the reasonableness of the request, the responding Federal partner's priorities, or legal restrictions. If Federal partners cannot reach consensus on a decision to share or not share information, the issue will be referred to the FDA Deputy Commissioner, the DoD Assistant Secretary of Defense (Health Affairs), the VHA Under Secretary for Health and/or the IHS Office of the Director for a final decision.

e. FDA, VHA, IHS, and DoD agree to establish reasonable timelines for responding to information requests and to refer instances of delays to the Agency liaisons for resolution.

f. FDA, DoD, IHS, and VHA recognize that information transmitted between them in any medium and from any source and that contains any of the following types of information must be protected from unauthorized 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 that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., Trade Secrets Act (l 8 U.S.C,§ 1905), the Privacy Act (5 U.S.C..§ 552a), the Freedom of Information Act (5 U.S.C. § 552), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq), and the Health Insurance Portability and Accountability Act (HIPAA, Pub. L. 104-191).

g. FDA, VHA, IHS, and DoD agree to promptly notify the relevant Federal partners of any actual or suspected unauthorized disclosure of information shared under this MOU.

4. GENERAL PROVISIONS

A. Safeguarding and Limiting Access to Shared Information

The procedures established under Section 3.b. must include proper safeguards against unauthorized use and disclosure of the information exchanged under this MOU. Proper safeguards shall include the adoption of policies and procedures to ensure that the information shared under this MOU shall be used solely in accordance with Trade Secrets Act [18 U.S.C. § 1905], the Federal Food, Drug. and Cosmetic Act [2l U.S.C. 301 et seq.], the Privacy Act of 1974, as amended [5 U.S.C.§ 552a], the Freedom of Information Act [5 U.S.C. § 552], and their implementing regulations, as well as the HIPAA Privacy Rule [45 C.F.R. Parts 160 and 164]. DoD, VHA, IHS, and FDA shall establish appropriate administrative, technical, procedural, and physical safeguards to protect the confidentiality of the information and to prevent unauthorized access to the information provided by the other Federal partner.

Access to the information shared under this MOU shall be restricted to authorized FDA, DoD, IHS, and VHA employees and officials who require access to perform their official duties in accordance with the uses of the information as authorized in this MOU. Such personnel shall be advised of (1) the confidential nature of the information; (2) safeguards required to protect the information; and (3) the administrative, civil, and criminal penalties for noncompliance contained in applicable Federal laws.

If an agency that has received information under this MOU receives a Freedom of Information Act (FOIA) request for the shared information, it will refer the request to the information-sharing agency for it to respond directly to the requestor regarding the releasability of the information. In such cases, the agency making the referral will notify the requestor that a referral has been made and that a response will issue directly from the information-sharing agency.

B. Restriction on Use of Information

All information provided by the Federal partners shall be used solely for the purposes outlined in Section 2. If a Federal partner wishes to use the information provided by one of the other Federal partners under this MOU for any purpose other than those outlined above, the requesting agency shall make a written request to the other agency describing the additional purposes for which it seeks to use the information. If the agency receiving this request determines that the request to use the information provided hereunder is acceptable, it shall provide the requesting agency with written approval of the additional use of the information.

C. Effect on Existing Statutes and Regulations

FDA, DoD, IHS, and VHA agree to take actions under this collaboration that are consistent with existing laws and regulations, and that nothing in the MOU shall be construed as changing the current requirements under statutes and regulations administered and enforced by DoD, VHA, IHS, and FDA, including but not limited to: Title 10 of the United States Code, the Public Health Service Act, and the Federal Food. Drug, and Cosmetic Act. Further, nothing contained in this MOU constitutes a mandate or a requirement imposed on FDA, IHS, VHA, or DoD that is additional to the mandates or requirements imposed on DoD, FDA, IHS, or VHA by Federal statutes and regulations.

5. ASSESSMENT MECHANISMS

FDA, IHS, VHA, and DoD staff involved in implementing the MOU will provide regular and consistent oversight and reevaluation of all terms and conditions contained herein.

6. TERMS, TERMINATION, OR MODIFICATION

This MOU becomes effective upon the signature of all Federal Partners and the implementation of the procedures and safeguards agreed upon by the Federal partners described in Section 3. This agreement may be modified by unanimous consent or terminated by any party upon 60 days written notice. This agreement may be modified by unanimous consent or terminated by any party immediately upon written notice if a Federal statute is enacted, or a regulation issued by a Federal partner that materially affects this MOU.

7. LIAISON OFFICERS

FOR FDA:

Nancy Guan, Pharm.D.
Richard Currey, PA-C
Science Policy Analysts
Office of the Center Director
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993

FOR VHA:

Peter Glassman, MBBS, MSc
Physician, Division of General Internal Medicine
Chair, Medical Advisory Panel for VA Pharmacy Benefits Management Services
Co-Director, VA Center for Medication Safety
VA Greater Los Angeles Healthcare System
11301 Wilshire Blvd (111G)
Los Angeles, CA 90073

FOR IHS:

Ryan Schupbach, Pharm.D., CAPT, USPHS
Vice Chair, IHS National Pharmacy & Therapeutics Committee
701 Market Drive
Oklahoma City, OK 73114

FOR DoD:

P. Thien Nguyen, Pharm.D., CDR, USPHS
Pharmacy Operations Division
Defense Health Agency
7700 Arlington Blvd, Suite 5101
Falls Church, VA 22042

APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION

Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Department of Health and Human Services
August 5, 2010

APPROVED AND ACCEPTED FOR THE DEPARTMENT OF DEFENSE

Jonathan Woodson, M.D.
Assistant Secretary of Defense (Health Affairs)
March 7, 2011

APPROVED AND ACCEPTED FOR THE VETERANS HEALTH ADMINISTRATION

Robert A. Petzel, M.D.
Under Secretary for Health
Veterans Health Administration
Department of Veterans Affairs

APPROVED AND ACCEPTED FOR INDIAN HEALTH SERVICE

Yvette Roubideaux, M.D., M.P.H.
Director, Indian Health Service
Department of Health and Human Services
Sept. 15, 2011


APPENDIX A

PROCESS FOR IN FORMATION SHARING

Pursuant to Section 3.d of this Memorandum of Understanding (MOU), any Federal partner 'may decide t shore information or expertise in response to a particular request for information made according to the procedures established under Section 3.b., or to limit the scope of information and expertise sharing in response to a particular request. Nothing in the process described below changes Section 3.d.

When, under the current MOU, staff at the FDA, the VHA, the DoD, or the IHS request from any or all other agencies information that may contain confidential material, the request should be in writing, which can include an informal email, and need only identify the subject for which information is requested. Although a more specific description of the information asked for may be helpful, it would not be required for purposes of making a request. However, the following language should be included in the request:

“Information that is shared under this request will be under the 2010-2011 FDA-VHA-DoD-IHS Memorandum of Understanding to Share lnfo1mation. We agree not to disclose any shared information in any manner without written permission to do so.”

With the inclusion of this statement, requestors would not have to use a format or include other pre-specified text.

A response to a request should also be in writing, but it, too, can be an informal email that acknowledges transmission of information in response to the request. Although identifying each piece of information/document provided may be helpful it would not be required for purposes of responding to a request. However, the following language should be included in the response:

“Pursuant to the 2010-2011 FDA, VHA, DoD, and IHS Memorandum of Understanding to Share lnformation, this communication may contain privileged and/or confidential information exempt from public disclosure. It may not be disclosed or shared in any manner outside of the parties to this MOU.”

With the inclusion of this language responders would not have to use a format or include other pre-specified text.

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