[Ip-health] Tufts: FDA's Fast Track Initiative Cut Total Drug Development Time

[Mike Palmedo]

http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=3D34

FDA=92s Fast Track Initiative Cut Total Drug Development Time by Three
Years, According to Tufts CSDD

11/13/2003

BOSTON =96 Nov. 13, 2003 =96 The U.S. Food and Drug Administration=92s (FDA=
)
fast track program to speed new drugs to market has shaved nearly three
years off the time usually required to develop a new drug and win
approval, according to 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.

=93The fast track program has had a significant public health impact by
speeding access to new drugs, particularly those that 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.,=94 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
development and approval of drugs that address unmet medical needs for
serious or life-threatening conditions.

=93The fast track program has clearly made a difference,=94 Milne said. =93=
By
1997, the FDA=92s 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.=94

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 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=92s 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 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, workshops, and public forums on related topics.