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Executive Summary

FDA is considering the implementation under the Action Plan of a new policy of helping small biotech drug companies through the approval process, FDA Commissioner Frank Young told an Association of Biotechnology Companies (ABC) meeting in Washington, D.C. March 29. "You will see the FDA in Action Plan Phase III . . . developing a major focus on biotechnology . . . as a form of competitiveness using a small business approach," Young said at ABC's Second International Meeting. FDA is "beginning to explore" ways to set up "a constant committee that would be able to give the appropriate advice to the company coming through" with applications for new biotechnology drugs, according to Young. The emphasis on small businesses would also be applied to food developers. The purpose for the small business focus would be "to cut down the carnage of the dropping out of applications during Phase I and Phase II" of the development process, Young explained. Noting the high attrition rate of developmental compounds at the large, experienced drug companies, Young observed: "If that's the performance of the well-established PMA companies, it is much more likely that there will be a larger drop-out rate from the [smaller] biotechnology companies from not having the experience in the long run of how to develop clinical trials and how to bring things through." The FDA commissioner suggested that special assistance to small biotech drug businesses could be modeled in some way after the small business division in the FDA Center for Devices and Radiological Health. He noted that the medical device center's small business office is designed "to give advice, to act as an ombudsman and help companies through the regulatory maze." However, FDA is not planning to establish a division for small businesses within the Centers for Drugs, Biologics, or Food Safety, Young said. He explained the plan is more one of attitude than structure. The small business focus "would be invisible in the sense of its existence as a format," Young said, "but it would be the way we would bring companies and applications in, almost analogous to the way we're now handling our AIDS program." For companies developing AIDS therapies, Young continued, "we're talking with them before they submit an IND, we're able to turn the IND around in about five days, then we're working with them to give advice and guidance on clinical trials during the time they're underway." The Patent and Trademark Office is also doing what it can to ease the regulatory burden on small biotech companies (see related T&G, this issue).

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