Specifically, the guidance provides details on the various types of user fees under GDUFA II, how companies can pay those fees, the consequences of not paying and who is responsible for paying them. The guidance also provides information on how refunds are handles and the appeals process for cases where FDA denies a request for a refund or fee reduction.
While the guidance does not address non-fee related processes and requirements under GDUFA II, FDA says it plans to issue additional guidance on other GDUFA II topics in the future.
In a change from GDUFA I, FDA will no longer collect prior approval supplement (PAS) fees and will now charge generic drug makers an annual “program fee” for the number of approved generic drug applications that the company and its affiliates own.
In total, FDA is authorized to collect five types of fees under GDUFA II: backlog fees, drug master file (DMF) fees; abbreviated new drug application (ANDA) filing fees; active pharmaceutical ingredient (API) and finished dosage form (FDF) facility fees; and GDUFA program fees.
The agency is also required to adjust the annual fee amounts for the various types of fees it collects to account for a set percentage of the total revenue collected each fiscal year.
**Fee Type** **Percentage** Drug master file (DMF) 5% Abbreviated New Drug Application (ANDA) 33% Active Pharmaceutical Ingredient (API) Facility 7% Finished Dosage Form (FDF) Facility 20% GDUFA Program Fee 35%
FDA says it will announce the new annual fees at least 60 days before the upcoming fiscal year, and in August, FDA announced GDUFA fee rates for FY2018.
FDA also clarifies that facilities that make both APIs and FDFs will only need to pay the fee for FDFs, not both, and that facilities that are only referenced in pending submissions will not need to pay a facility fee. Additionally, FDA says that contract manufacturing organizations (CMOs) that make FDFs only need to pay one-third of the FDF facility fee.
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