BOSTON, MA -- (MARKET WIRE) -- 07/10/08 -- Post-approval study commitments, in which drugdevelopers, as a condition of regulatory approval, agree to conductresearch on newly marketed prescription drugs, are becoming routine in theUnited States, Europe, and Japan, according to a recently completedanalysis 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 between1998 and 2008, and 50 percent of those approved in Japan during the sametime, had postmarketing study commitments attached to them, Tufts CSDDfound.
"What used to be the exception is increasingly becoming the rule for newdrug approvals," said Christopher-Paul Milne, associate director at TuftsCSDD 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 areidentified earlier and the increased knowledge of a drug's safety andefficacy allows drug sponsors to serve patient populations better."
Postmarketing commitments, referred to as post-approval commitments in theEU and as postmarketing surveys in Japan, aim to generate information on,for example, a product's safety and efficacy, its prescribing or use, andits consistency of manufacturing.
The Tufts CSDD analysis, reported in the July/August Tufts CSDD ImpactReport, 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 ofpharmaceutical development, review, and utilization. Tufts CSDD, based inBoston, conducts a wide range of in-depth analyses on pharmaceutical issuesand hosts symposia, workshops, and public forums, and publishes the TuftsCSDD Impact Report, a bi-monthly newsletter providing analysis and insightinto critical drug development issues.
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