MOU 225-20-005
MEMORANDUM OF UNDERSTANDING AND CONFIDENTIALITY AGREEMENT
BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR VETERINARY MEDICINE
AND
MEDICAL MANAGEMENT INTERNATIONAL, INC., a Delaware
corporation that does business as Banfield Pet Hospital®
I. Purpose
The U.S. Food and Drug Administration (FDA) and the Banfield Pet Hospital (Banfield) share interests in promoting animal health and furthering scientific knowledge through the exchange of information on adverse events and disease epidemiology associated with the use of animal food, drugs and devices. This Memorandum of Understanding (MOU) establishes a strategic framework for collaboration between FDA and Banfield and outlines the process for sharing of information between the FDA and Banfield.
II. Background
The FDA promotes and protects the public health by ensuring the safety of animal food and the safety and effectiveness of animal drugs and devices. The FDA administers the FD&C Act (see generally, 21 U.S.C. § 301 et. seq.) and certain sections of the Public Health Service Act (see, e.g., 42 U.S.C. § 262), among other statutes. Among its duties, the FDA reviews applications for animal drugs and food additives, conducts inspections of manufacturing facilities to make sure that animal food and drugs are made under current good manufacturing practices regulations, and monitors post-marketing adverse events, and investigates complaints.
Banfield Pet Hospital is a full service, nationwide small-animal practice. They have more than 930 hospitals in 42 states and provide services for nearly 8.5 million medical visits per year.
This MOU documents an agreement between FDA and Banfield with respect to the sharing of pharmacovigilance data. This information sharing will aid in enhancing the detection, assessment, understanding and prevention of adverse effects associated with FDA regulated products. Banfield would benefit by learning about pharmacovigilance (PV) best practices, data mining of large clinical databases, and use of statistical algorithms to detect safety signals.
III. General Provisions
a. FDA may request, and Banfield agrees to provide:
- Information from Banfield’s electronic health record data, including epidemiologic or demographic information;
- Information from Banfield’s electronic health record data about a specific disease or condition of interest to FDA;
- Information from Banfield’s electronic health record data about specific product or class of products that have been potentially associated with a safety signal or other concern that FDA has publicly acknowledged (e.g., in a health safety alert, warning letter, or other publicly available information).
b. Each party acknowledges and agrees that Banfield may share information about pharmacovigilance best practices, data mining of large clinical databases, and use of statistical algorithms to detect safety signals that it obtains from FDA with parent company Mars, Incorporated, an affiliate of Medical Management International, Inc. This MOU does not authorize, and FDA does not intend to, share any confidential commercial, trade secret, or personal privacy information with Banfield.
c. Banfield understands that FDA may reference Banfield data as a source of information concerning adverse events and/or disease epidemiology in public safety notifications.
d. FDA shall establish appropriate safeguards to protect the confidentiality of the information provided by Banfield and to prevent unauthorized access to the information provided. In accordance with applicable laws and regulations, including, but not limited to, 21 U.S.C. § 331(j), 21 U.S.C. § 360j(c), 18 U.S.C. § 1905, 21 CFR 20.61 and 20.63, FDA will not share any confidential commercial information, trade secrets, or personal privacy information received pursuant to this MOU with the public.
e. Nothing in this agreement is intended to limit FDA’s authority to investigate a safety issue or take necessary action to protect public health.
IV. Resource Obligations
This MOU represents the broad outline of Banfield and FDA's intent to share information to further their common goal to improve the health of animals. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements between FDA and Banfield or change any existing obligations of either party under the law.
V. Information Sharing
For purposes of this Agreement, “Confidential Commercial Information” is defined under 21 CFR 20.61(b). Confidential Commercial Information shall be considered confidential and shall be subject to this Agreement whether or not it is marked or designated “confidential” at the time of disclosure to FDA. Notwithstanding the provisions above, FDA may disclose Confidential Commercial Information to its Agents who have a legitimate “need to know,” provided that FDA shall deliver a copy of this Agreement to each Agent before any Confidential Commercial Information is disclosed to such Agent unless the Agent is already bound by a confidentiality agreement that covers such Confidential Commercial Information. FDA shall be fully responsible for any use or disclosure of Confidential Commercial Information by any of its Agents in violation of this Agreement.
FDA will maintain and comply with administrative, technical and physical safeguards that are designed to protect the security and integrity of the Confidential Commercial Information, including in connection with any transfer, communication, remote access or storage of the Confidential Commercial Information as permitted or required under this Agreement. FDA will immediately notify Banfield of any unauthorized disclosure or use of Banfield’s Confidential Commercial Information.
In the event that FDA, or any of its Agents, are compelled by subpoena, order, or in any other manner to disclose any information received from Banfield that FDA has substantial reason to believe could reasonably be considered Confidential Commercial Information, FDA will give Banfield prompt notice of such request so that Banfield may seek an appropriate protective order. If FDA or any of its Agents is nevertheless compelled by legal process to disclose such information, FDA may make such disclosure without liability, FDA agrees to give Banfield notice under 21 CFR 20.61(e) in the event of a request received under the Federal Freedom of Information Act (5 U.S.C. § 552) for Confidential Commercial Information shared pursuant to this agreement, or when the FDA has substantial reason to believe that such information could reasonably be considered exempt under exemption 4 of the Freedom of Information Act. The procedures outlined in 21 CFR 20.61(e) regarding pre-disclosure notification govern the process by which the FDA is to give notice to Banfield.
Applicable laws and potential remedies. Any cause of action and potential remedies available to Banfield for the improper release of Confidential Commercial Information by FDA are provided under existing federal law.
VI. Liaison Officers
A. For the Food and Drug Administration:
Dr. Hesha J. Duggirala, Epidemiologist
FDA, CVM, Office of Surveillance and Compliance
7519 Standish Pl., HFV-200
Rockville, MD 20855
240-402-6218
hesha.duggirala@fda.hhs.gov
B. For Banfield Pet Hospital:
Jo Ann Morrison, DVM, MS, DACVIM
Director, Veterinary Science
Banfield Pet Hospital
18101 SE 6th Way, Vancouver, WA 98687
360-784-5082
JoAnn.Morrison@banfield.com
FDA and Banfield may designate new Liaison Officers at any time by notifying the other's Liaison Officer in writing. If, at any time, an FDA or Banfield Liaison Officer becomes unavailable to fulfill those functions, a new Liaison Officer will be designated within two weeks.
VII. Term, Termination, and Modification
This MOU will be effective when signed by FDA and Banfield. This MOU may be modified by mutual written consent by the Participants or may be terminated by either FDA or Banfield upon written notice to the other.
APPROVED AND ACCEPTED FOR BANFIELD PET HOSPITAL
Dr. Jo Ann Morrison
Director, Veterinary Science
Banfield Pet Hospital
Date: 03/23/2020
APPROVED AND ACCEPTED FOR THE
FOOD AND DRUG ADMINISTRATION
Dr. Steven Solomon
Director, Center for Veterinary Medicine
Date: 04/02/2020