Calls for postmarket trials resisted as GAO slams USA

The US Food and Drug Administration has come under severe criticism for its failure to address the issue of drug safety once approval has been given. A report by the US Government Accountability Office, requested in late 2004 following the withdrawal of USA-based drug major Merck & Co's Vioxx (rofecoxib), has highlighted necessary improvements in the decision-making for postmarket drug safety.

FDA "must track postmarket safety"

In particular, the GAO recommends that the US Congress should "consider expanding FDA's authority to require drug sponsors to conduct postmarket studies when needed." The drug regulatory agency should also "systematically" track postmarket drug safety issues and clarify the role of the Office of Drug Safety.