Fast Track Program Firmly Established in U.S., According to Tufts Center for the Study of Drug Development.

BOSTON -- Fast track drug development, introduced in the United States in 1997, has become an important element of the drug development landscape, according to a recently completed analysis by the Tufts Center for the Study of Drug Development.

Between the start of 1998 and the end of 2005, nearly 500 fast track designations have been granted by the U.S. Food and Drug Administration (FDA), accounting for approximately 20% of all active investigational compounds in clinical development programs worldwide during that time, Tufts CSDD reported in its March/April Tufts CSDD Impact Report, published today.

"The fast track program has had a significant public health impact by speeding access to drugs to treat AIDS, breast cancer, leukemia, and other diseases that afflict millions of patients and result in the loss of tens of thousands of lives every year in the U.S.," said Christopher Milne, Tufts CSDD assistant director and author of the study.

"The program's value is underscored by the fact the FDA is evaluating fast track mechanisms for possible expansion of the scope of eligible products."

The fast track program, part of the FDA Modernization Act of 1997, was introduced to expedite development and approval of new prescription medicines that address unmet medical needs for serious or life-threatening conditions. While a formal fast track program currently exists only in the United States, international interest in similar fast track mechanisms is growing in Europe, Japan and China, according to Milne.

The Tufts CSDD analysis also found that:

--Cancer-related programs today account for 40 percent of all fast track designations.

--While HIV/AIDS accounted for about 20% of all fast track designations in 2001, it now accounts for 8%.

--Total development time for fast track products is about the same as for non-fast track standard and priority review drugs - eight years on average.

--Total development times for fast tracked products vary considerably by therapeutic area: nine years on average for cancer, five years for anti-infectives (mostly for HIV/AIDS treatments), and seven years for other indications (primarily rare diseases and orphan indications).

--Currently, approximately one-third of all fast track programs are struggling, with efficacy issues in late-stage trials being the major source of problems.

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 provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums on related topics, and publishes the Tufts CSDD Impact Report, a bi-monthly newsletter providing analysis and insight into critical drug development issues.