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Avandia Advisory Committee: Can Poking Old Wounds Be Good For FDA?

 
• By Cathy Dombrowski

Two advisory panels will revisit the question of whether FDA should withdraw GlaxoSmithKline’s Avandia from the market as a reevaluation of the cardiovascular trial produces results similar to the original findings; the data does not seem to offer much more clarity, but does give the agency a chance to argue it handled previous controversies well.

FDA has placed itself it the unusual position of revisiting a regulatory decision well after making a lifecycle-altering change to a product’s marketing. Fortunately for the agency, the data that will be discussed at the June 5-6 advisory committee review of the safety of GlaxoSmithKline PLC’s diabetes drug Avandia appears very similar to the information considered by the agency in 2010 when it decided to keep the drug on the market with restrictions.

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