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Pharmaceuticals / Regulatory Affairs

Senate HELP Committee Schedules May 10 Vote on FDA User Fees

May 11, 2017

The Senate HELP Committee is expected to vote on a legislation package reauthorizing the FDA’s user fee programs.

Current user fee agreements are set to expire Sept. 30. If the agreements are not reauthorized 60 days ahead of the deadline, the FDA would be forced to lay off more than 5,000 employees and cripple the agency’s ability to review drug and device applications.

The PDUFA, GDUFA and BsUFA programs would take in $1.42 billion for fiscal 2018, up from the $1 billion set for fiscal 2017. The projected base fees collected under PDUFA next fiscal year would increase by more than 22 percent, to $878.59 million from $718.67 in fiscal 2017.

The committee held two hearings this spring on the user fees, listening to testimony from FDA experts and witnesses representing patients and drug makers.

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