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FDA ACTION PLAN PHASE III DRAFT

Executive Summary

FDA ACTION PLAN PHASE III DRAFT will be completed in a "couple of weeks," FDA Commissioner Young reported at the Food and Drug Law Institute's 32nd Annual Education Conference held Nov. 29-30. Young commented, "We'll have at least the draft ready" for the Action Plan Phase III "in another couple of weeks. The commissioner pointed out that "the centerpiece" of the Action Plan Phase III is going to focus on biotechnology and that "the theme is going to be cooperation between academe, government, and industry." He added that FDA this year will begin an initiative to share facilities for biotechnology research. The agency will make available renovated facilities at the National Center for Toxicological Research in Arkansas for use by small biotech companies and academic groups ("The Pink Sheet" Oct. 17, p. 4). "FDA must devise better interaction with professionals, consumers, and industry so that products, once marketed, receive proper postmarket surveillance," Young said. In addition, the agency must also develop better interactions with academia "through training grants and other partnerships, to improve our science base and our knowledge about the products we regulate." Young also underscored the need for "good, focused clinical endpoints" and noted that FDA has a contract with the Infectious Disease Society of America to update endpoints for infectious diseases. A public mistrust of the health care system has arisen in the last few years, Young said. In order to combat that mistrust, Young mentioned that the parties involved "must move even further from confrontation to collaboration." The commissioner cited agency-industry collaboration in biotechnology research as one of seven directions for FDA to move toward for developing stronger partnerships with those involved in the health care system. Com. Young is scheduled to meet with senior execs from the biotechnology industry in early December to open up a direct line of communications between the industry and FDA topside.

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