Generic drugmakers submitting abbreviated new drug applications (ANDAs) and prior approval supplements (PAS) will see their US Food and Drug Administration (FDA) fee rates drop in 2017, though all other rates, including those for drug master files (DMF) and facility fees will increase when compared to 2016.
For FY 2017, the generic drug fee rates are: ANDA ($70,480, down from $76,030 in 2016), PAS ($35,240, down from $38,020 in 2016), DMF ($51,140, up from $42,170 in 2016), domestic active pharmaceutical ingredient (API) facility ($44,234, up from $40,867 in 2016), foreign API facility ($59,234, up from $55,867 in 2016), domestic finished dose formulation (FDF) facility ($258,646, up from $243,905), and foreign FDF facility ($273,646, up from $258,905 in 2016).
The new fees are effective 1 October 2016 and will remain in effect through 30 September 2017.
FDA explained the increases and decreases in fees, noting that for ANDA and PAS fees, the agency is expecting an increase in the number of submissions estimated to be submitted in FY 2017 when compared to 2016. For 2017, the agency estimates that approximately 891 new original ANDAs and 439 PASs will be submitted and incur filing fees.
Fees for DMFs will increase, meanwhile, because of an expected decrease in the number of submissions estimated to be submitted in 2017 (FDA is estimating 379 fee-paying DMFs for 2017), when compared to the estimated submissions from 2016.
And all facility fees will increase in 2017 when compared to the previous year because of a decrease in the number of facilities that self-identified (the total number of FDF facilities identified through self-identification was 675, of which 255 were domestic facilities and 420 foreign facilities; while the total number of API facilities self-identified was 789, of which 101 were domestic facilities and 688 were foreign facilities), FDA said.
How FDA Calculates the Fees
In order to calculate the ANDA fee, FDA estimated the number of full application equivalents (FAEs) that will be submitted in FY 2017, which is done by assuming ANDAs count as one FAE and PASs (supplements) count as one-half of an FAE, since the fee for a PAS is one half of the fee for an ANDA.
The Generic Drug User Fee Act (GDUFA) also requires that 75% of the fee paid for an ANDA or PAS filing be refunded if either application is refused due to issues other than a failure to pay the fees.
And since this is the last year of this iteration of GDUFA (the next version is still in the works), the agency is allowed to further increase the fee revenues and fees established if such an adjustment is necessary to provide for not more than three months of operating reserves for the first three months of FY 2018, though FDA estimates that the GDUFA program will have carryover balances for such activities in excess of three months of such operating reserves, so FDA will not be performing a final year adjustment.
To pay the fees, companies must complete a Generic Drug User Fee Cover Sheet, available at http://www.fda.gov/gdufa and generate a user fee identification (ID) number. Payment must be made in US currency drawn on a US bank by electronic check, check, bank draft, US postal money order or wire transfer.
Federal Register Notice