The Generic Drug User Fee Act - A Brief Overview

The Generic Drug User Fee Act (GDUFA) was signed into law as part of the 2012 Food and Drug Administration Safety and Innovation Act. It sets in motion the administrative steps needed to better fund the Agency's review of generic drug products—a process in which an abbreviated new drug application (ANDA) review now takes almost three years. The goal is to bring this review time down to less than a year. However, it is definitely a work in progress.

Only 25% of the personnel intended to be added to the generic drug division will be hired by the End of FY 2013 (Sep 30 2013) and another 50% by the end of the FY2014. By the end of year three after the enactment of the Act, the FDA agreed that 60% of submitted ANDA's will be acted on in 15 months. By the end of year five, 80% of submitted ANDA's will be acted on within 10 months. This compares to an average of 31 months for ANDA review currently. The FDA has also committed to clear their backlog of 2500 ANDA's now in-house by the end of five years.

So, there is little reason to withhold filing of ANDA's at this point. The GDUFA also has a provision for first in, first to be reviewed. So early submission is still the best strategy for optimizing approval time.

Now, what about fees? There is now a fee due on the filing of an ANDA of $51,520 (FY2013). There is also a fee due in connection with the filing of ANDA supplements that are deemed "prior approval supplements" (PAS), such as those detailing significant manufacturing changes-- the PAS fee for FY2013 is $25,760. There was a one time "backlog" fee of $17,434 on ANDA's pending and not yet approved on October, 2012. There is an annual generic drug finished dosage form facility fee (FY2013 $$175,389 for domestic facilities and $15,000 more for foreign facilities) and an annual API facility (one making an API that is intended to be identified in a Type II drug master file (DMF)) of $26,458 for domestic facilities ($15,000 more for foreign facilities). DMF's can be submitted without the payment of a fee, but a fee of $21,340 is due the first time a generic drug application is submitted that references the DMF.

So the FDA has now implemented a la carte pricing for generic drug activities confirming the old adage that there is no free lunch.