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eHealth Initiative Foundation Launches Collaborative Research Effort to Improve Drug Safety
Date:11/29/2007

elve-month period, Collaboration participants will test and evaluate safety signals using a combination of clinical and administrative data for three "use cases," including the use of cholesterol-lowering drugs and laboratory results related to liver failure, warfarin-related bleeding episodes, and a small set of adverse patient events commonly associated with medications, or "designated medical events" through research conducted in two clinical environments in Indianapolis, IN, and Boston, MA. Insights gleaned from these two "learning laboratories" will be documented and converted into technical guides and tools that will be made widely available to the public to stimulate advancement of drug safety efforts in the field.

This initiative is intended to contribute to the creation of an active drug safety surveillance system in the U.S., which is a key provision of the recent Food and Drug Administration Amendments Act (FDAAA) of 2007 signed into law just two months ago. The Food and Drug Administration will work with the Collaboration in an advisory capacity. "We are very excited about this effort," said Janet Woodcock, MD, Deputy Commissioner and Chief Medical Officer, Food and Drug Administration. "This is a wonderful example of how public and private organizations can work together to benefit the public health."

The Collaboration expects its learnings to contribute to and build off of those of the Reagan-Udall Foundation, a new private and independent non-profit organization established by Congress under the FDAAA. The mission of the Foundation is to identify and help to address the unmet scientific needs in the development, manufacture, and evaluation of the safety and effectiveness of FDA-regulated products, including post-market evaluation.

Mark McClellan, MD, PhD, Director of the Engelberg Center for Health Care Reform at the Brookings Institution and Chair of the Reagan-Udall Foundation's Board, applauded the effort, in saying that
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