FDA's Fast Track Initiative Cut Total Drug Development Time by Three Years, According to Tufts Center for the Study of Drug Development.Business Editors/Health/Medical Writers BOSTON--(BUSINESS WIRE)--Nov. 13, 2003 The U.S. Food and Drug Administration's (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) fast track program to speed new drugs to market has shaved shave v. shaved, shaved or shav·en , shav·ing, shaves v.tr. 1. a. To remove the beard or other body hair from, with a razor or shaver: nearly three years off the time usually required to develop a new drug and win approval, according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. a recently completed analysis by the Tufts Center for the Study of Drug Development. The study found that clinical development time for fast track drugs approved between 1998 and 2003 was, on average, 2 to 2.5 years shorter than for non-fast track drugs. "The fast track program has had a significant public health impact by speeding access to new drugs, particularly those that treat AIDS, breast cancer, leukemia leukemia (l  kē`mēə), cancerous disorder of the blood-forming tissues (bone marrow, lymphatics, liver, spleen) characterized by excessive production of immature or mature , and other diseases that afflict af·flict tr.v. af·flict·ed, af·flict·ing, af·flicts To inflict grievous physical or mental suffering on. [Middle English afflighten, from afflight, millions of patients and result in the loss of tens of thousands of lives every year in the U.S.," said Tufts Center Associate Director Christopher-Paul Milne. The Tufts Center examined implementation of the fast track program since it took effect in late 1997. The fast track program aims to expedite ex·pe·dite tr.v. ex·pe·dit·ed, ex·pe·dit·ing, ex·pe·dites 1. To speed up the progress of; accelerate. 2. development and approval of drugs that address unmet medical needs for serious or life-threatening conditions. "The fast track program has clearly made a difference," Milne said. "By 1997, the FDA's five-year-old accelerated approval regulations had resulted in about 20 approvals; within its first five years the fast track program led to 200 fast track product development designations and another two dozen approvals." In addition to generating more designations and approvals, the fast track program is being used for development programs focusing on a growing number of disease indications. According to Milne, fast track designations for products aimed at treating diseases other than cancer and HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome grew from more than 30 in 2001 to more than 50 in 2003. Other key findings from the Tufts Center analysis: - Although average approval time for fast track biologicals was shorter than that for priority or standard biologicals, longer average clinical development time resulted in a slightly longer total development time for fast track biologicals. - Nearly 10% of fast track designations in 2003 were for diabetes and obesity, reflecting the FDA's recent emphasis on conditions that contribute significantly to health care costs and that would benefit from innovative treatments. - As more AIDS and AIDS-related medicines became available during the late 1990s, the share of AIDS fast track designations fell by more than half between 2001 and 2003. About the Tufts Center for the Study of Drug Development The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) at Tufts University Tufts University, main campus at Medford, Mass.; coeducational; chartered 1852 by Universalists as a college for men. It became a university in 1955. Jackson College, formerly a coordinate undergraduate college for women, merged with the College of Liberal Arts in provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. The Tufts Center, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia sym·po·si·a n. A plural of symposium. , workshops, and public forums on related topics. |
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