BOSTON, MA -- (MARKET WIRE) -- March 13, 2007 -- The average cost to complete pediatric research
on already marketed prescription drugs, in response to a request from the
U.S. Food and Drug Administration (FDA), increased nearly eight times
between 2000 and 2006, according to findings released today by the Tufts
Center for the Study of Drug Development.
The increase, in nominal dollars, from $3.93 million in 2000 to $30.82
million in 2006, is consistent with the general increase in cost, length,
and complexity for developing new drugs, Tufts CSDD said.
The analysis also found that during the first 10 years of an FDA program
that seeks to encourage pediatric research, such studies have been
undertaken on more than 100 diseases and conditions and have led to new
labeling for 120 new or already approved drugs for use in children.
"While the cost to complete pediatric studies has soared, drug companies
are not letting that get in their way," said Tufts CSDD Associate Director
Christopher Milne. "The Best Pharmaceuticals for Children Act seems to be
doing its job, which is to generate more pediatric studies. The bottom line
is that better prescribing information and more formulations are being
developed for children."
To improve U.S. labeling of prescription drugs for children, the FDA since
1998 has managed a program in which it asks pharmaceutical companies to
conduct pediatric studies on marketed products in exchange for six
additional months of market protection, known as pediatric exclusivity, for
all of its products that contain the active ingredient being studied. The
Best Pharmaceuticals for Children Act, which authorizes this program, is
due for renewal in October.
The Tufts CSDD findings were based on a survey conducted last fall by Milne
and Laura Faden, following up on a similar survey undertaken by Tufts CSDD
in 2000.
Since the pediatric exclusivity program began, the FDA reports that it has
issued 336 requests for 782 studies involving 46,000 children. During the
same time, the cumulative number of pediatric studies completed and
subsequently accepted by the FDA, rose from 58 in 2000 to an estimated 568
in 2006, according to Tufts CSDD.
The study, reported in the March/April Tufts CSDD Impact Report, released
today, also found that:
-- Efficacy/safety studies, the most resource-intensive and expensive
type of study, now account for 40% of all pediatric studies conducted, up
from 25% in 2000.
-- Time required to complete a study and submit a final report nearly
doubled since 2000.
-- The mean number of patients required for studies in response to an FDA
request was up 178% between 2000 and 2006, and the mean number of studies
per request rose 60%.
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.
Contact Information: Contacts:
Tufts Center for the Study of Drug Development
Peg Hewitt
617-636-2185
Email Contact
Business Communication Strategies
Peter Lowy
781-326-9980
Email Contact