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FDA significantly increases generic user fees in 2019

Generics/General | Posted 07/09/2018 0 Post your comment

The US Food and Drug Administration (FDA) has increased the amount that generics manufacturers will have to pay for large-size operation generic drug applicants by more than US$270,000 for fiscal year (FY) 2019 compared to 2018.

The increases were announced by FDA in a July 2018 Federal Register notice. Active pharmaceutical ingredient (API) manufacturers, on the other hand, will actually see a small decrease in fees and finished drug formulation (FDF) facilities remain almost the same.

The fees come as part of the Generic Drug User Fee Amendments II (GDUFA II), which was approved by the US Congress on 18 August 2017 [1].

The FY 2019 fees for finished dosage form (FDF) and API facilities for US and foreign generics manufacturers, as well as the GDUFA programme and application fees, which are due on 1 October 2018, are:

	2018 (US$)	2019 (US$)
Applications
ANDA	171,823	178,799
DMF	47,829	55,013
Facilities
Domestic API	45,367	44,226
Foreign API	60,367	59,226
Domestic FDF	211,087	211,305
Foreign FDF	226,087	226,305
GDUFA programme
Large-size operation generic drug applicant	1,590,792	1,862,167
Medium-size operation generic drug applicant	636,317	744,867
Small business operation generic drug applicant	159,079	186,217

Large-size operation generic drug applicant programme user fees increase by more than US$270,000. For medium-size operations, the fee is increasing by more than US$100,000 and for small operations the fee jumps by more than US$27,000. The agency is also increasing the fees for ANDA applications and drug master files (DMFs) by around US$7,000.

The extra cost for non-US manufacturers has been kept the same as in 2018, as being US$15,000 more than domestic facilities. This has been calculated by FDA to be sufficient to cover the higher costs of inspecting foreign facilities.

All applicants that submit an ANDA must pay the FY 2019 filing fee on or after 1 October 2018.

Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues final guidance on ANDA/PAS amendments [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 7]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-ANDA-PAS-amendments

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Source: Federal Register, US FDA