Burr Warns User Fee Renewal Could Be Difficult Without Performance Measure Improvements
This article was originally published in The Pink Sheet Daily
Senator tells FDA Commissioner Hamburg that time to market is important metric during hearing dominated by questions about medical device review.
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Sen. Burr asks FDA whether fee revenue should be rebated for not meeting some PDUFA V goals.
House is expected to vote on the reconciled FDA user fee bill June 20. Negotiators picked Senate GAIN language, including its less prescriptive qualifying pathogen definition.
FDA met most user fee performance goals for NDAs and BLAs received in fiscal years 2000 through 2010, the government watchdog agency says in a report prepared for Sens. Burr and Coburn. The legislators proposed legislation April 16 that includes a requirement for the agency to report annually on its adherence to the user fee goals.