BOSTON, MA--(Marketwire - November 12, 2008) - While the number of annual new drug approvals in
the United States has declined during the past decade, the U.S. remains the
preferred market for launching new products, according to a recently
completed analysis conducted by the Tufts Center for the Study of Drug
Development.
The study found that new U.S. drug approvals dropped to 48 in 2005-07, from
a peak of 110 in 1996-98.
During 2005-07, the most recent period for which information is available,
drugs first marketed in the U.S. accounted for 75% of all new drugs
approved worldwide, an all time high, according to Tufts CSDD. This was a
marked change from the 1987-89 period, when only 20% of new drugs were
first marketed in the U.S.
"The United States has become the country of choice to introduce new
prescription drugs to the market due, in large part, to the size of the
pharmaceutical market, the positive environment for innovation, and the
lack of price controls," said Tufts CSDD Director Kenneth I Kaitin. "For
example, because many countries limit the prices that drug companies can
charge for their products, they turn to the U.S."
He noted that the decline in new drug approvals reflects the increasingly
time-consuming, risky, and expensive nature of drug development, which is
related to the industry's focus on developing new medicines to treat a host
of chronic and complex diseases.
The Tufts CSDD analysis, reported in the November/December Tufts CSDD
Impact Report, released today, also found that:
-- Combined clinical and approval times for new drugs developed in the
U.S. have dropped to the lowest level since the late 1990s.
-- Since enactment of Prescription Drug User Fee Act of 1992, average
approval times declined generally and reached their lowest three-year
average (1.1 years) in 2005-07.
-- Following a jump in clinical times for priority and standard drugs in
2002-04, those numbers in 2005-07 returned to levels similar to those
observed in 1996-98 and 1999-01.
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