EUROPE LAGS BEHIND U.S. IN DRUG APPROVALS

The U.S. approves drugs more quickly than the European Union, a study by the Tufts Center for the Study of Drug Development finds.

In the study, "EMEA Meets Performance Goals, But Lags U.S. FDA in Drug Approvals," researchers assessed drug approvals from 2000 to 2005, comparing the European Medicines Agency's (EMEA) reviews with those of the FDA.

The study found that while the mean review time for both agencies was nearly identical, the U.S. approved 52 of the 71 products assessed before its European counterpart did. As a result, companies are more likely to first seek approval in the U.S. This finding is a "reversal of the previously observed drug lag between the U.S. and Europe," the report said.

But the EMEA did improve its review times by adopting numerous FDA policies, including conditional marketing authorization and accelerated assessments.

The benefits of adopting FDA policies bode well for future drug development, Kenneth Kaitin, director of the center at Tufts, said. "Looking ahead, we expect that greater collaboration between the EMEA and FDA will further enhance product development in both regions. It will also help avoid duplicative testing and provide another way to hold down development costs."

A summary of the report is available at csdd.tufts.edu/_documents/www/Doc_309_58_893.pdf (http://csdd.tufts.edu/_documents/www/Doc_309_58_893.pdf).