BOSTON, MA--(Marketwire - September 3, 2008) - New drugs that receive fast track designation by
the U.S. Food and Drug Administration (FDA) experience shorter clinical and
approval times compared to drugs without the designation, according to a
recently completed study of the first decade of the fast track program
conducted by the Tufts Center for the Study of Drug Development.
Total average clinical and approval time for fast track drugs was 5% faster
than for all drugs -- 73.1 vs. 77.0 months -- according to Tufts CSDD. The
study looked at 344 drugs that received at least one FDA fast track
designation since 1998.
The fast track program was authorized by Congress in 1997 and implemented
the following year.
"Since many drugs that receive fast track designation are being developed
to treat serious or life-threatening conditions, such as AIDS, breast
cancer, and leukemia, development hurdles are significant, resulting in
longer clinical times than is the case for all drugs as a whole," said
Janice M. Reichert, senior research fellow at Tufts CSDD and the author of
the study. "Speedier FDA review, however, leads to shorter combined
clinical and approval times for fast track drugs."
According to Tufts CSDD, clinical development time for fast track drugs was
6% longer than it was for all drugs (64.7 vs. 61.2 months). But average FDA
approval review time for fast track drugs was considerably shorter than for
drugs as a whole -- an average of 8.4 vs. 15.8 months (for products that
began clinical tests in 1992 or later and approved during 1998-07).
The Tufts CSDD analysis, reported in the September/October Tufts CSDD
Impact Report, released today, also found that:
-- Fast track designations for new drug candidates have grown
substantially, from an average of 22 per year during 1998-02 to 49 per year
during 2003-07.
-- Anticancer candidates received the largest share of fast track
designations since the program began.
-- Fast track indications are more likely to be terminated during
development than non-fast track indications, with efficacy being the
primary reason for termination of fast track-designated candidates.
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, and publishes the Tufts
CSDD Impact Report, a bi-monthly newsletter providing analysis and insight
into critical drug development issues.
Contact Information: Contact:
Tufts Center for the Study of Drug Development
Charlene Neu
617-636-2187
Business Communication Strategies
Peter Lowy
617-734-9980