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Health and Human Services (HHS) Secretary Mike Leavitt and HHS' Food and Drug Administration (FDA) has released an initial list of priority research projects that could advance innovation in medical products. The announcement of the Critical Path Opportunities List signals the next major step in FDA's Critical Path Initiative, aimed at modernizing medical product development, so new medical discoveries are brought to patients faster and at a lower cost.

The Opportunities List outlines an initial 76 projects to bridge the gap between the quick pace of new biomedical discoveries and the slower pace at which those discoveries are currently developed into therapies. The release of the list marks a starting point in identifying priorities to be accomplished under the Critical Path Initiative. Government, industry and academic experts estimate that, if accomplished, the new tests and tools developed under the Critical Path Initiative will modernize the drug development process by 2010 and help to get new medical discoveries to patients faster and at a lower cost.



"This Opportunities List enhances the health and well-being of Americans by fostering strong, sustained scientific advances in medicine to better public health," Secretary Leavitt said. "Medical product development relies on cutting-edge scientific tools to help identify promising medical discoveries and target testing for benefits and risks when they are used by patients."

The Critical Path Opportunities List, the first specific blueprint for this nationwide modernization initiative, was developed based on feedback to the agency's 2004 Critical Path Report. The report diagnosed a slowdown in the development of innovative medical therapies, and proposed an FDA-sponsored long-term initiative to address the problem. The research projects in the Opportunities List, designed to deliver smarter tools to evaluate candidate medical products, were identified through numerous sources including public comment, inter-agency consultations, and FDA product reviewers who know first-hand the obstacles encountered by medical product development.

"Right now, researchers are trying to bring 21 st century medical innovations to market using 20 th century tools to evaluate them. Under the Critical Path Initiative, we anticipate being able to dramatically increase the success rate in moving products from the lab to the patient," said Dr. Andrew C. von Eschenbach, Acting FDA Commissioner. "The keys to a smarter more modern medical product development process are the standardization of new tools to test potential products along with the unprecedented integration of information within government, industry and academic partnerships."

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