BioCentury finds FDA has $270M in GDUFA, PDUFA fees in hand

The FDA said when the budget impasse hit last week that it could continue some of its work, relying on the various user fees it collects from prescription and generic drugmakers. But how much is that, and how long will it last? BioCentury asked the FDA and found this out: The agency had $152.5 million in GDUFA carryover fees as of Oct. 1, to do things like plant inspections and drug approvals, and another $119.7 million in unspent or carryover PDUFA fees. The FDA told BioCentury that while there is no exact formula for how much it will spend, "under normal circumstances, FDA projected that it would spend approximately $170M during the first three months of FY 2013." StoryMore