September 23,2010

Baucus Applauds FDA Avandia Decision


September 23, 2010

To: Reporters and Editors
From: Scott Mulhauser and Erin Shields for Senate Finance Committee Chairman Max Baucus (D-Mont.)
Re: Baucus Applauds FDA Avandia Decision

Senate Finance Committee Chairman Max Baucus (D-Mont.) today applauded the Food and Drug Administration’s (FDA) announcement that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone).   Today’s announcement came after a two year inquiry into Avandia by Baucus and Finance Committee Ranking Member Chuck Grassley (R – Iowa).  In February, Baucus and Grassley released a Finance Committee report which uncovered documents suggesting that GlaxoSmithKline, the manufacturer of Avandia, failed to publish studies that found serious health risks associated with Avandia in a timely manner and actively promoted the drug despite the known safety concerns.  Baucus and Grassley also provided findings from their ongoing Avandia inquiry to the FDA in July showing that GlaxoSmithKline failed to promptly alert the FDA about Avandia’s risks.  From Chairman Baucus:

“Patients and doctors have a right to know the risks of the medicines they use and prescribe.  Our investigation into Avandia exposed major safety risks and showed that information is the most important tool the FDA has to protect American consumers.  The FDA’s tough new restrictions on the drug will help protect patients.  We will continue watching closely and working with the FDA to make sure patients and doctors are aware of the risks associated with Avandia and all drugs so they can make safe and informed decisions when choosing their medicines.”