FDA Panel Votes to Restrict Billion-Dollar Drug, Avandia

Friday, July 16, 2010

GlaxoSmithKline got some very bad news this week from an advisory panel to the Food and Drug Administration (FDA) when it voted to restrict the sales of Avandia, a controversial diabetes drug. Concerned about reports of the drug causing heart attacks, a majority of the 33-member advisory committee expressed support either to limit the sale of Avandia or to add more warnings to its label. Twelve of the 31 members who actually voted supported banning the drug altogether and three voted to leave the rules exactly as they are.

 
Avandia earned the company $1.1 billion in sales last year.
 
The FDA still must decide whether to accept the committee’s recommendation.
 
GlaxoSmithKline is a major lobbying force in Washington, having spent $8.7 million in 2009 and $2.2 million so far this year to persuade lawmakers and federal officials.  
-David Wallechinsky
 
F.D.A. Panel Votes to Restrict Avandia (by Gardiner Harris, New York Times)

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