Regulatory Focus™ > News Articles > Reauthorization of User Fee Acts on Congressional Agenda for 2012

Reauthorization of User Fee Acts on Congressional Agenda for 2012

Posted 04 January 2012 | By Alexander Gaffney, RAC 

The new year will bring new political battles and new bills-including the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA)-to the 112th congress.

The two Acts, both of which require reauthorization this year, may attract unwanted political attention, says National Journal writer Meghan McCarthy.

"Democrats and Republicans have been working behind the scenes to get an agreement on clean bills that authorize the programs and don't contain unrelated health legislation. But with the PDUFA and MDUFA bills the only stand-alone health legislation likely to move in this Congress, they will almost certainly attract political amendments that could slow them down over the summer months."

PDUFA and MDUFA are both set to expire in September, making the prospect of any slowdown a dangerous one for the US Food and Drug Administration and pharmaceutical industry alike. FDA is expected to issue final recommendations on the PDUFA legislation on 15 January 2012.

The legislation would cover FY2013-2017 and require more communication between FDA and industry.

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