Follow up on the NYT article on GSK and their drug, Avandia that we blogged about recently
A Senate report that revives concerns about a GlaxoSmithKline PLC diabetes drug’s link to heart attacks is putting pressure on the Food and Drug Administration to make changes to its drug-safety program.
People familiar with the situation say agency leaders held calls over the weekend to discuss how to address complaints from Sens. Max Baucus (D., Mont.) and Chuck Grassley (R., Iowa), who released a new report Saturday on the Glaxo drug, called Avandia.
The FDA is trying to assemble a timeline of what the FDA knew of risks associated with Avandia, these people say, and plans to call a meeting of an outside advisory committee in the next few months to look at recent information on the drug, which Glaxo reported as having global sales of £771 million ($1.2 billion) in 2009.
According to a two-year investigation by the Senate Finance Committee, Glaxo knew about data linking Avandia to elevated risk of cardiovascular events for several years, but played down the information and tried to suppress doctors who raised concerns. Starting in 1999, Glaxo executives complained to superiors about researchers who questioned Avandia’s safety, the report says.
[Click to continue reading Glaxo Drug Faces More Scrutiny – WSJ.com]
and the FDA is certainly not blameless in this mess
Some critics of the FDA cited the Avandia report in renewing calls for an independent safety unit at the agency to track problems with drugs after they go on the market. Currently the section that does “post-market surveillance” is subordinate to the division that approves new drugs. As a result, there is an inherent conflict of interest because the approval officers are judging their own previous decisions, critics say.
The question is: will public outrage be sufficiently heated to force some structural changes in the FDA? Jury is still out…