US FDA Might Face Funding Penalty For Missing User-Fee Goals
Industry representatives support adding a provision to the user-fee agreements that would withdraw some taxpayer funding if the agency does not meet its deliverables.
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A provision in the FDARA user-fee bill prevents FDA from spending user-fee revenue on building maintenance costs beginning in FY 2023, which could deter future recruitment and retention of the "world's best and brightest" scientists at FDA, House Energy and Commerce ranking member Frank Pallone says.
Sen. Burr asks FDA whether fee revenue should be rebated for not meeting some PDUFA V goals.
President wants substantially more user fee revenue than negotiated in user fee agreements, and some in industry already are warning that requiring increases now could endanger program reauthorizations.