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Avandia Vote at FDA Kept Secret, Leads to Questions From US Senator

Oct 30, 2007 | Parker Waichman LLP

Avandia may have been the subject of a secret vote by a Food & Drug Administration (FDA) panel in which it apparently decided by a one-vote margin to keep the controversial drug on the market.  Now, a member of the US Senate wants to know if the report of the 8-7 vote by the FDA’s Drug Safety Oversight Board is accurate, and if so, why the agency has yet to make this vote public.

Avandia has been under intense scrutiny since May when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack.  During a congressional hearing earlier this summer, the drug’s maker, GlaxoSmithKline, and the FDA have came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia.  Testimony at that hearing revealed that the company and the FDA had known about the heart attack risk as far back as September 2005. In July, the FDA convened a panel to discuss the issues surrounding Avandia’s heart attack risk.  The panel voted 20-3 that the drug did in fact raise the chance of heart attacks, yet the panel still voted 22-1 to allow it to remain on the market.  

Now, the FDA’s conduct in relation to Avandia is being called into question by Senator Charles Grassley, the leading Republican on the Senate Finance Committee.  According to Senator Grassley’s office, the committee recently learned that the Drug Safety Oversight Board had voted 8-7 on October 2 to keep Avandia on the market.  While the board’s meetings are not open to the public, details of these meetings are published on the FDA website.  So far, this has not been done.  

Now Senator Grassley wants information on that meeting and vote, and he said in a statement that the FDA’s failure to inform the public of the close Avandia vote presents “new rounds of questions about the way the FDA monitors and assesses drug risks and decides whether to let the public know about emerging risks.”   So far, the FDA has not responded to the Senator’s concerns.  

GlaxoSmithKline, which continues to insist that Avandia is safe, is currently negotiating with the FDA to include a new black box warning about the drug’s heart attack risks on its labels.  It is not known when that new warning will finally appear on Avandia.


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