BOSTON, MA--(Marketwire - July 10, 2008) - Post-approval study commitments, in which drug
developers, as a condition of regulatory approval, agree to conduct
research on newly marketed prescription drugs, are becoming routine in the
United States, Europe, and Japan, according to a recently completed
analysis conducted by the Tufts Center for the Study of Drug Development.
Seventy-five percent of new drugs approved in the U.S. and the EU between
1998 and 2008, and 50 percent of those approved in Japan during the same
time, had postmarketing study commitments attached to them, Tufts CSDD
found.
"What used to be the exception is increasingly becoming the rule for new
drug approvals," said Christopher-Paul Milne, associate director at Tufts
CSDD and the study's author.
"While post-approval studies increase the cost of marketing new medicines,
they may offer a silver lining in that potential safety issues are
identified earlier and the increased knowledge of a drug's safety and
efficacy allows drug sponsors to serve patient populations better."
Postmarketing commitments, referred to as post-approval commitments in the
EU and as postmarketing surveys in Japan, aim to generate information on,
for example, a product's safety and efficacy, its prescribing or use, and
its consistency of manufacturing.
The Tufts CSDD analysis, reported in the July/August Tufts CSDD Impact
Report, released today, also found that:
-- The average number of postmarketing studies per new drug, of those
requiring studies, ranges from 10.8 in the EU to 8.9 in the U.S. to 1.7 in
Japan, and varies by therapeutic area.
-- When required, postmarketing commitments in the EU and Japan are more
likely than in the U.S. to relate to safety concerns.
-- Half of the products approved with postmarketing commitments in the
U.S. and EU had pediatric study requirements, compared to only 6% in Japan.
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