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Regulatory Focus™ > News Articles > Congress Scrambles to Pass User Fee Fix for Generics, Leaving Others in Limbo

Congress Scrambles to Pass User Fee Fix for Generics, Leaving Others in Limbo

Posted 21 September 2012 | By Alexander Gaffney, RAC

Congress is scrambling to pass a piece of legislation that would allow the US Food and Drug Administration (FDA) to collect and spend user fees, just days after reports raised the prospect of a budget resolution barring the agency from doing so.

A bill, The FDA User Fee Corrections Act of 2012(HR 6433), was introduced in the US House of Representatives on Wednesday, 19 September by Reps. Fred Upton (R-MI) and Henry Waxman (D-CA), and was passed unanimously later the same day.

The bill provides a fix to allow FDA to collect nearly $300 million in generic drug user fees, which FDA is slated to use to bolster its inspection activities and reduce a massive backlog of generic drug applications. The legislation would not, however, provide a similar fix for prescription drug, medical device or biosimilar user fees, all of which would be kept at their fiscal year 2012 levels unless a separate fix is passed.

The bill now heads to the Senate, where it has not yet been placed on the legislative calendar. A constricted schedule and other legislative matters may yet complicate the bill's passage, which must occur before the Senate adjourns for an election season recess, scheduled to begin this weekend and last until after the election.

BioCentury - House passes bill to access generic user fees

FDA Law Blog - Legislative Fix Would Allow FDA to Collect GDUFA User Fees