Tufts report reveals increasing use of post-release studies of new drugs

August 5, 2008

Boston - A recently released analysis shows that studies of prescription drugs following their release on the market are becoming more common in the United States, Europe and Japan, The Boston Globe reports.

Boston - A recently released analysis shows that studies of prescription drugs following their release on the market are becoming more common in the United States, Europe and Japan, The Boston Globe reports.

Boston’s Tufts Center for the Study of Drug Development did the analysis, which reveals that in many cases, pharma companies agree to do post-release studies as a condition of being granted regulatory approval to market their drug.

The Tufts report says that over the past 10 years, 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 Globe story quotes the Center’s associate director, Christopher-Paul Milne, as saying, “What used to be the exception is increasingly becoming the rule for new drug approvals. 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.”