BIO Applauds FDA for Recognizing Serious Impediments to Creating New Medicines

WASHINGTON, D.C. (March 17, 2004) — Biotechnology Industry Organization (BIO) President Carl B. Feldbaum issued the following statement in response to the release of the Food and Drug Administration (FDA) report, "Challenge and Opportunity on the Critical Path to New Medical Products":

"This is a courageous statement from a government agency recognizing the serious problems that are preventing new, innovative drugs and biologics from getting to the patients who need them. As the FDA acknowledges, its own standard-setting process (in drug development) must be 'informed by the best science ...' "

"Our companies have made tremendous strides in the drug discovery process, but the enormous costs and difficulties associated with moving research from the lab bench to the patient cannot be overstated. That is why the agency is calling for a new product development toolkit designed to eliminate inefficiencies and better detect product safety and effectiveness with more certainty and at lower costs.

"BIO is pleased to work with the FDA to develop those tools and other measures necessary to streamline and improve the product development process."

BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products. For more information, visit www.bio.org.