1. Pink Sheet

FDA’s Generic Drug Office Goes On Diet Before Swallowing User Fees

 
• By Cathy Dombrowski

Congress sets $52.9 million floor for Office of Generic Drugs in FY 2012, less than in 2011, as part of $3.8 billion FDA funding package. Overall, FDA gets a $50 million boost, but sequestration looms. Appropriations conferees enter the user fee debate, asking how fast FDA approves drug applications.

Congress has set the floor for FDA’s Office of Generic Drugs funding at $52.947 million in fiscal 2012, almost 5% less than the minimum of $55.5 million it directed FDA to spend on OGD in fiscal 2011.

FDA proposed a budget of $88.8 million for OGD in fiscal 2012. But $40 million of that was to have come from $40 million in generic drug user fees that are not yet authorized

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