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January 30, 2007

Media Inquiries:
Sandy Walsh and Susan Cruzan,
Consumer Inquiries:

FDA and VA to Share Information on the Safe Use of Medical Products

The U.S. Food and Drug Administration (FDA) in the U.S. Department of Health and Human Services and the Veterans Health Administration (VHA) in the U.S. Department of Veterans Affairs (VA) announced today that they have signed a memorandum of understanding (MOU) to share information and expertise related to the review and use of FDA-regulated drugs, biologics and medical devices (medical products). This partnership is part of the ongoing drug and medical product safety initiatives detailed in a report released today by the FDA.

The goals of the collaboration are to explore ways to enhance postmarket medical product safety data collection and risk communication through more robust interagency activities. It will promote efficient use of tools and expertise for medical product risk identification, validation and analysis. Additionally, this effort will help build infrastructure and processes that meet the common needs for evaluating the safety, efficacy and use of medical products.

"Patient safety is our primary concern," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "This collaboration will benefit VHA, FDA and all Americans by enhancing our ability to fully understand the life cycle of a product. It will also better enable us to identify new risks and more fully understand known risks caused by specific medical products as well as to better communicate that information to health care practitioners and patients."

"This truly is a natural partnership," said Michael Kussman, M.D., Acting Under Secretary for Health for VHA. "VHA offers enrolled veterans the largest integrated health care system in the nation and leads the way in many areas of health care quality and safety. We are eager to continue to work with FDA to accomplish our shared mission of protecting public health."

By strengthening the process for postmarketing safety, VHA and FDA are continuing to improve the safe and effective use of medical products by using the best management approaches, the best information technology and the best quality systems and review processes.

All personal health information exchanged under the agreement will be protected in accordance with federal law.

For a copy of the MOU, visit: www.fda.gov/oc/mous/domestic/225-07-4300.html.


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