FDA Issues Draft Guidance on GDUFA II User-Fee StructureBy
The US Food and Drug Administration (FDA) has issued draft guidance, Assessing User Fees Under the Generic Drug User Fee Amendments of 2017, to outline the new user-fee structure under the Generic Drug User Fee Amendments of 2017 (GDUFA II), which reauthorized generic-drug user fees for fiscal years 2018-2022.
The draft guidance provides an explanation about the new fee structure and types of fees for which entities are responsible.
Specifically, the draft guidance describes the types of user fees, the process for submitting payments to the FDA, the consequences for failing to pay the fees, and the process for requesting a reconsideration of a user-fee assessment.
The GDUFA II authorizes the collection of five types of fees: (1) backlog fees; (2) drug master file (DMF) fees; (3) abbreviated new drug application (ANDA) filing fees; (4) active pharmaceutical ingredient (API) and finished dosage form (FDF) facility fees; and (5) generic drug applicant program fees (GDUFA Program Fees). The statute directs FDA to set annual fee amounts for each fiscal year so that DMF fees will account for 5%, ANDA fees 33%, API facility fees 7%, FDF facility fees 20%, and GDUFA Program Fees 35% of the total revenue amount determined for a fiscal year.
In terms of changes from GDUFA I, a prior approval supplement filing fee, which was previously required, is no longer required under GDUFA II.
The draft guidance said the FDA will issue separate guidance documents regarding GDUFA II non-user fee requirements and processes.