FDA Posts FY2020 GDUFA Fees

The FDA and the Department of Health and Human Services published the Generic Drug User Fee Rates for Fiscal Year 2020 specifying fees for ANDA and DMF submissions, annual active ANDA holdings, and API and finished dosage form (FDF) facilities next fiscal year, beginning October 1, 2019.

Thanks to efforts during GDUFA II negotiations by PBOA, a non-profit trade association that represents the interests of pharma and biopharma CMOs and CDMOs, CMO facilities (which are defined as FDF sites that are referenced by approved ANDAs that are not owned by the owner of the facility or its affiliate companies) now pay one-third of what a non-CMO FDF site pays. Also, the portion of GDUFA's budget covered by FDF facilities was reduced from 56% to 20%, with much of the difference covered by the new ANDA Program Fee. The reduction in FDF facility fees in FY2020 is due to higher estimates of non-CMO facilities in the US and overseas, presumably as a result of more ANDAs getting approved in "first-time" facilities.

Ex-U.S. facilities, both API and FDF, pay $15,000 more per site than U.S. facilities. GDUFA's annual budget will grow 2.29% in FY2020 from $501,721,000 to $513,223,000.

FY2020 Facility Fees

Domestic CMO FDF facility: $65,221 (-7.4%)

Ex-US CMO FDF facility: $80,221 (-6.1%)

Domestic non-CMO FDF facility: $195,662 (-7.4%)

Ex-US non-CMO FDF facility: $210,662 (-6.9%)

Domestic API facility: $44,400 (+0.4%)

Ex-US API facility: $59,400 (+0.3%)

FY2020 Application Fees

ANDA: $176,237 (-1.4%)

DMF: $57,795 (+5.1%)

FY2020 ANDA Program Fee

1-5 Approved ANDAs: $166,168 (-10.8%)

6-19 Approved ANDAs: $664,674 (-10.8%)

20+ Approved ANDAs: $1,661,684 (-10.8%)

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