Today, an advisory panel met to discuss and vote on whether or not to recommend if the FDA should pull diabetes drug Avandia from the market over a possible link to increased risk of heart attacks. In the end, the voting leaves no definite direction for how the FDA will ultimately come down on the issue.
In the final vote on whether or not to recommend pulling Avandia, a product of pharma biggie GlaxoSmithKline, 12 panel members said it should be taken off the market; 10 said it should still be sold, but only with serious revisions to its labeling and possible restrictions on its sale; 7 members were fine with just adding some more warnings to the drug’s labeling; 3 said it should continue to be sold as is.
Writes the NY Times, who spent the day live-blogging the various votes:
The vote is an enormous blow to Avandia and GlaxoSmithKline. The vast majority of panel members voted either to withdraw the drug or to allow continued sales only if strict controls are added.
Now the FDA takes the panel’s suggestions into account before making its final decision.
Earlier this year, the Senate Finance Committee took the FDA to task, alleging that the agency’s drug-approval system held too much sway over its post-market investigation department, causing a conflict of interest.
Blogging the F.D.A. Vote on Avandia [NY Times]