Overview: In 1992, Congress created the Prescription Drug User Fee Act (PDUFA) in order to combat an excessively lengthy and costly drug approval process. The general premise is that the PDUFA authorizes the FDA to collect fees from companies that submit an NDA (New Drug Application) or a BLA (Biologics License Application). These fees have supported more than 2,000 full-time jobs at the FDA as of FY2012, allowing the agency to reduce not only its review timeline but conduct more follow-ups, “particularly the number of post-market patient safety reviews and the number of examinations of imported goods.”
As enacted, the PDUFA must be reauthorized every 5 years. According to the FDA, “[o]n July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA), which includes the reauthorization of PDUFA through September 2017. PDUFA V will provide for the continued timely review of new drug and biologic license applications.”
Because of user fees, PDUFA has been a key component to expediting the drug approval process. Without it, the FDA will not be permitted to collect fees, decreasing the number of drugs launched in the US first and early US access to new medicines. According to the National Bureau of Economic Research,
“…the impacts of PDUFA on drug approval times…were trending downwards at 1.7% percent per year prior to implementation of PDUFA…. Our principal finding is that PDUFA accelerated this downward trend so that instead of a counterfactual 6% reduction in approval times from 24.2 to 20.4 months in absence of these acts between 1991 and 2002, there was an observed decline of about 42%, from 24.2 to 14.2 months, following implementation of PDUFA. Thus, of the total observed decline in approval times between 1991 and 2002, approximately two-thirds can be attributed to PDUFA. However, much of this impact occurred in the initial years between 1992 and 1997 (PDUFA-I) rather than during the subsequent 1997-2002 time frame (PDUFA-II).”
Without the reauthorization of PDUFA, the FDA would no longer have the rights to collect fees to fund additional drug review processes. The industry at risk to seeing longer approval, since there would be no incentive to keep these processes expedited. This would not only negative impact key players in the industry such as manufactures and distributors, but also end consumers as well.