The head of the US Food and Drug Administration will attend a hearing tomorrow to consider the administration's role in sanctioning Avandia
The US Food and Drug Administration is to be questioned over its decision to approve Avandia, a diabetes drug produced by GlaxoSmithKline, following the release of a recent report linking the drug to an increase in heart attacks and death.
Chairman of the Committee on Oversight and Government Reform, Henry Waxman, has called FDA commissioner Andrew von Eschenbach to a hearing tomorrow to consider the administration's role in the evaluation of the drug's safety eight years ago.
The move follows the publication of a report in the New England Journal of Medicine in May entitled "Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes," which claimed that the drug increased the risk of heart attacks by over 40%.
Prior to tomorrow's hearing, Waxman has requested that Eschenbach provide detailed information on the steps taken eight years ago by the FDA to assess the safety of the drug. The information is expected to include all communications between the GlaxoSmithKline, and FDA relating to cardiovascular safety ofrosiglitazone, and all related internal FDA analyses, slide presentations, and memoranda.
Author of the report, Dr Steven Nissen, MD, MACC, chairman of the department of Cardiovascular medicine at the Cleveland Clinic Foundation, will also be attending the hearing.
A request to attend was also sent to Jean-Pierre Gamier, chief executive of GlaxoSmithKline, asking Garnier to "come prepared to discuss your company's actions with regard to the cardiovascular safety of Avandia". Moncef Slaoui, chairman of research and development at GlaxoSmithKline, is to attend the hearing.
The Avandia study has raised serious concerns over the effectiveness of measures to ensure drug safety levels in the US and it is expected that the hearing will result in a concerted drive to further strengthen drug-related legislation.
