On Friday, July 27th, FDA released a notice with updated generic drug user fee rates for fiscal year 2019. Under GDUFA II, user fees should total $493,600,000 each year, adjusted for inflation. The updated fees are effective October 1, 2018 through September 30, 2019.
Generic Drug Fee Rates
|Fee Category||FY 2019 Fee Rates|
|Domestic API Facility||$44,226|
|Foreign API Facility||$59,226|
|Generic Drug Applicant (Large Business)||$1,862,167|
|Generic Drug Applicant (Medium Business)||$744,867|
|Generic Drug Applicant (Small Business)||$186,217|
ANDA Filing Fee
Any applicant submitting an ANDA after October 1st, 2018 will owe the updated FY 2019 fee, which is due on the ANDA’s submission date. The FY 2019 ANDA fee was calculated by dividing the number of full application equivalents (FAEs) into the revenue from ANDA application fees. The FY 2019 ANDA filing fee is $178,799.
Anyone who owns a type II active pharmaceutical ingredient DMF that is referenced in a generic drug submission on or before October 1, 2012, owes a DMF fee. “This fee is due on the earlier of the date on which the first generic drug submission is submitted that references the associated DMF or the date on which the drug master file holder requests the initial completeness assessment.” This is a one-time fee (for each DMF), and the FY 2019 DMF fee was calculated by dividing the total DMF target revenue by the estimated number of fee-paying DMFs. The FY 2019 DMF fee is $55,013.
Foreign Facility Fee Differential
Due to higher inspection costs, facilities located outside of the United States owe an additional $15,000 in facility fees.
FDF & CMO Facility Fees
According to Section 744B(b)(2)(c) of the FD&C Act, FDF and CMO facility fees are to make up 20% of total revenue, or $100,344,200. Under GDUFA II, the CMO facility fee should be 1/3 the amount of the FDF facility fee. Therefore, for FY 2019, the domestic CMO fee is $70,435 and the domestic FDF facility fee is $211,305. If the facility is not located in the United States or its territories, an additional $15,000 fee applies.
API Facility Fee
Anyone who owns a facility that has been identified in at least one approved generic drug submission or in a Type II API DMF referenced in at least one approved generic submission owes an API facility fee. The FY 2019 API facility fee is $44,226 while the foreign API fee is $59,226.
Generic Drug Applicant Program Fee
The generic drug applicant program fee depends on the size of the business, which is determined by the total number of approved ANDAs a company has.
- Small Business: 1-5 approved ANDAs, owe $186,217
- Medium Size Operation: 6-19 approved ANDAs, owe $744,867
- Large Size Operation: 20+ approved ANDAs, owe $1,862,167
Large companies pay the full program fee, while medium sized operations pay two-fifths of the full fee and small businesses pay one-tenth of the full fee.