1. Both PhRMA and the FDA credited the user fee act, which assesses fees on the industry in return for faster reviews, with improving approval times. 2. Furthermore, the user fee act requires that the fees be over and above base appropriations, executives said. 3. He added, though, that the administration wants to see the user fee act renewed and is in favor of some measure of FDA reform. 4. He said he wanted to see changes at the agency as part of a renewal of the user fee act. 5. Industry representatives will ask Congress to separate the two bills if it appears that controversy over FDA overhaul will delay the user fee act, she said. 6. Jeffords said the delays are jeopardizing renewal of the critically important user fee act, which is part of the FDA overhaul bill. 7. Officials argue that the fee structure acts as an incentive to keep children in foster care. 8. Republican committee members, though, said the user fee act would help push through needed changes at the agency. 9. Senate leaders have also said they plan to tie their own agency overhaul measures to renewal of the user fee act. 10. The FDA attributed its faster pace to the user fee act, which requires companies to pay fees in return for more staff and speedier reviews at the agency. |