FDA details shutdown finances

FDA has enough money from unspent user fees to cover about two months of PDUFA operations during a shutdown, according to calculations based on data the agency provided BioCentury on Wednesday. As of Oct. 1, FDA had $119.7 million in unspent, or carryover, fees to fund drug reviews and some other activities during the shutdown. The agency said it is "extremely difficult" to estimate how long these funds will last, but "under normal circumstances, FDA projected that it would spend approximately $170M during the first three months of FY 2013." The agency said it will "prioritize the user fee work we can continue to do as needed given our limited pool of funding."

FDA's carryover funds "can continue to be spent during the shutdown, but they can only be spent on the activities authorized under the user fee laws." The agency cannot accept any regulatory submissions for FY14 that require a fee (see BioCentury Extra, Oct. 4). ...