Getting a Jump on PDUFA V: Fast Start on REMS, Patient Input

Getting a Jump on PDUFA V: Fast Start on REMS, Patient Input – And Longer Reviews

01 Jun 2012

• By Cole Werble and Michael McCaughan

The new Prescription Drug User Fee Act Program doesn’t take effect until October 1, but FDA has been getting moving on some key elements of the program since before the final negotiations began on Capitol Hill. FDA will need to move fast to meet the many policy deadlines set by the agreement negotiated with industry.

Starting to implement a law before it is signed sounds dangerous. Just suggesting the possibility has an insidious undertone; but, in the case of some recent actions by the FDA in advance of the Prescription Drug User Fee Act reauthorization, it looks more like a sign of the wise use of the full PDUFA process to manage the agency efficiently.

In several areas, FDA has begun processes that are well within its current authority so that it will be ahead...