Harkin urges quick FDA decision on fate of Avandia

Sen. Tom Harkin (D-Iowa), chairman of the Senate Health Committee, is calling on the Food and Drug Administration (FDA) to reach a quick verdict on the fate of Avandia.

A panel of FDA experts met for two days this week to discuss the health risks associated with the blockbuster diabetes drug, which is manufactured by GlaxoSmithKline. On Wednesday, 12 members of that panel voted to pull the drug from the market, while 20 voted for it to remain available (though nearly all of those suggested additional restrictions or label warnings.) 

The mixed verdict puts the ultimate decision in the hands of Margaret Hamburg, who heads the FDA.

“It is imperative that the risks associated with its use be properly understood and vetted,” Harkin said in a statement Wednesday. “I urge FDA to carefully consider today’s deliberations by the Joint Advisory Committee, and to make a final decision on how best to protect consumers as soon as possible.”  

“The safety of those suffering with diabetes must be our primary concern,” Harkin said.