US Congress probes FDA on Avandia concerns

The US House of Representatives' Committee on Oversight and Reform, chaired by Rep Henry Waxman, (Democrat, California) organized a hearing on June 6, to consider the Food and Drug Administration's handling of the safety of UK-headquartered drug major GlaxoSmithKline's diabetes agent Avandia (rosiglitazone). The move follows the publication in the New England Journal of Medicine of of a meta-analysis, the validity of which is disputed, claiming a 43% increase in the risk of myocardial infarction and a 64% rise in the risk of death from cardiovascular causes (Marketletter May 28).

Among the political battles being staged around the hearings is a struggle between two factions within the FDA, according to the New York Times. Senator Charles Grassley (Republican, Iowa), the ranking member on the Senate's Health, Education, Labor and Pensions Committee, was reported in the NY Times as favoring a split between the agency's drug approval and safety departments, with the latter having increased authority. Safety campaigners have reportedly been demanding a black box warning for Avandia, which has been resisted by the FDA's drug review division.

The FDA's Commissioner, Andrew von Eschenbach, warned of the dangers of overreaction to uncertain safety concerns. He told a gathering of journalists before the hearing that "the point is that we need to look at the role of the FDA in being a bridge to the future, not a barrier to the future."