In Sept. 23, 2010, the Food and Drug Administration (FDA) announced that rosiglitazone (Avandia), a diabetes drug manufactured by GlaxoSmithKline (GSK), would be the subject of a stringent Risk Evaluation and Management Strategy (REMS) that will undoubtedly greatly reduce its use. At the same time, the European Medicines Agency (EMA) announced that marketing of rosiglitazone was suspended, but formal approval had not been revoked. FDA also halted the Thiazolidinedione Intervention with Vitamin D (TIDE) trial, a head-to-head cardiovascular safety comparison of rosiglitazone and a similar drug, pioglitazone, which GSK had undertaken at FDA's request. FDA halted the trial because of doubts about whether it would yield useful results or was even feasible in the face of safety concerns about rosiglitazone. In addition, GSK agreed to cease all promotional activities for rosiglitazone.
These coordinated announcements were the culmination of more than three years of sometimes impassioned debate over the safety of rosiglitazone. This episode is not over. FDA has commissioned an independent assessment of an important, but flawed, safety trial of rosiglitazone (the RECORD trial discussed below). If the published RECORD results hold up, rosiglitazone could yet be freed from the strict REMS imposed in the United States and could even be restored to the E.U. market. In any case, this episode is revealing much about the continuing evolution of FDA drug regulation.
John E. Calfee is a resident scholar at AEI.