2012 Food and Drug Administration Safety and Innovation Act

The law which was originally enacted as the Prescription Drug User Fee Act (PDUFA) and is re-authorized every five years, renews a commitment to applicant funding of FDA drug and device reviews, while requiring transparency, speed, and other process improvements. Funding for the agency from 2013 through 2017 is expected to substantially increase, and for the first time, generics and biosimilars are now subject to user fees; a significant change for a market that is shifting increasingly to the usage of generic medications.

The legislation revamps the medical device approval process and imposes stricter oversight of global drug and device supply chains. Also antibiotics and rare disease drug incentives are increased and drug shortages gain additional attention and resources.
The 2012 Food and Drug Administration Safety and Innovation Act

FY2008-2012 FDA fee revenues vs. FY2013-2017 projected fee revenues

FDA user fees charged to pharmaceutical and device companies are expected to increase by about $3.2 B in the 2013-2017 time period. This represents a 103% increase over 2008-2012 fees. Over half of the money will come from new user fees on generic drugs and biosimilars, also referred to as follow-on biologics. While the fees on branded prescription drugs and biologics track closely with those in the 2007 re-authorization, user fees for medical devices more than double in FDASIA.

Look for papers, articles, and case studies. See all thought leadership.