FDA announces generic user fee for FY2020; lessens fee load for copycat drugmakers | 07 August, 2019

The US Food and Drug Administration (FDA) released its GDUFA II user fees for fiscal 2020. Unlike the previous year, when most fees saw a significant increase, the fees for the upcoming year are either marginally lowered or remain unchanged.

The new GDUFA II fees will come into effect on October 1

Fee category	GDUFA II fee for FY 2020*	GDUFA II fee for FY 2019	GDUFA II fee for FY 2018
Applications
ANDA	176,237	178,799	171,823
DMF	57,795	55,013	47,829
Facilities
Domestic API facility	44,400	44,226	45,367
Foreign API facility	59,400	59,226	60,367
Domestic FDF facility	195,662	211,305	211,087
Foreign FDF facility	210,662	226,305	226,087
Domestic CMO facility	65,221	70,435	70,362
Foreign CMO facility	80,221	85,435	85,362
GDUFA program
(20+ANDAs) Large-size operation generic drug applicant program	1,661,684	1,862,167	1,590,792
(6-19 ANDAs) Medium-size operation drug applicant program	664,674	744,867	636,317
(1-5 ANDAs) Small business generic drug applicant program	166,168	186,217	159,079

*The fee is applicable from October 1, 2019, until September 30, 2020.

GDUFA II stipulates that user fees should total US$ 493,600,000 annually, adjusted each year for inflation. The FDA utilized data from ANDAs submitted from October 1, 2013, to April 30, 2018, to estimate the number of new original ANDAs that will incur filing fees in FY 2019.

For FY 2020, the base revenue amount is US$ 501,721,201.

The FDA estimates that approximately 953 new original ANDAs and 444 DMFs will be submitted and incur filing fees. PharmaCompass’ analysis has shown a gradual drop in the number of facilities paying GDUFA fees each year and it remains to be seen if the reduction of fees leads to an increase in registrations.

(Source: PharmaCompass)