In his evidence to the US Senate hearing on the Vioxx withdrawal, Food and Drug Administration (FDA) official, Dr David Graham, described the agency's new drug reviews division and its management of the Office of Drug Safety (ODS) as the greatest obstacles to effectively protecting the American public against drug safety risks1. Dr Graham, who is associate director for science and medicine at the ODS (a division of the FDA Center for Drug Evaluation and Research - CDER), was speaking at a US Senate Committee on Finance investigation entitled ‘FDA, Merck and Vioxx: Putting Patient Safety First?', held on 18 November 2004. At the hearing, he criticised Merck - the manufacturer of Vioxx - and the FDA, for not withdrawing the COX-2 inhibiting nonsteroidal anti-inflammatory drug (NSAID) sooner.
In addition to addressing the safety issues surrounding Vioxx, the hearing was intended to address the adequacy of the entire...