Follow-up drug studies are becoming more routine
Studies of prescription drugs following their release on the market are becoming increasingly routine in the United States, Europe, and Japan, according to a new analysis by the Tufts Center for the Study of Drug Development.
In many cases, pharmaceutical companies have agreed to do such post-release studies as a condition of being granted regulatory approval to market a particular drug, the Tufts Center said.
Over the last decade, 75 percent of new drugs approved in the United States and the European Union and 50 percent of those approved in Japan had post-marketing study commitments attached to them, the Tufts Center analysis found.
"What used to be the exception is increasingly becoming the rule for new drug approvals," Christopher-Paul Milne, associate director at the center and the study's author, said in a statement. "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."
(By Chris Reidy, Globe staff)
