FDA Unveils FY 2019 GDUFA, BsUFA and MDUFA Fees
With the new five-year user fee programs now in their second year, generic drug and medical device companies are seeing increases in user fees while biosimilar companies are seeing decreases.On the generics side, 2019 fees for Abbreviated New Drug Applications (ANDAs) have increased by more than $100,000 since 2017, though the increase over last year has been less than $10,000.
Meanwhile, GDUFA program fees for large generic drug applicants have increased by more than $200,000 since last year.
Bernstein analyst Ronny Gal noted FDA is seeing a “sharp reduction in small companies participating in the generic industry … We do not believe we are close to the bottom yet.”
GDUFA II Fee Rates for 2019
| Fee category | Fees rates for FY 2019 |
|---|---|
| Applications: | |
| Abbreviated New Drug Application (ANDA) | $178,799 |
| Drug Master File (DMF) | 55,013 |
| Facilities: | |
| Active Pharmaceutical Ingredient (API) Domestic | 44,226 |
| API—Foreign | 59,226 |
| Finished Dosage Form (FDF)—Domestic | 211,305 |
| FDF—Foreign | 226,305 |
| Contract Manufacturing Organization (CMO)—Domestic | 70,435 |
| CMO—Foreign | 85,435 |
| GDUFA Program: | |
| Large size operation generic drug applicant | 1,862,167 |
| Medium size operation generic drug applicant | 744,867 |
| Small business operation generic drug applicant | 186,217 |
On the medical device side, 2019 fees are up slightly from 2018, though the standard fee for a 510(k) premarket notification submission increased by only a couple hundred dollars, from $10,566 in 2018 to $10,953 in 2019, though both figures are more than double the 2017 figure, when the fee was $4,690.
Medical Device Fees for FY 2019
| Application fee type | Standard fee (as a percent of the standard fee for a premarket application) | FY 2019 standard fee | FY 2019 small business fee |
|---|---|---|---|
| Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act (21 U.S.C. 360e(f), or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262)) | Base fee specified in statute | $322,147 | $80,537 |
| Premarket report (submitted under section 515(c)(2) of the FD&C Act) | 100 | 322,147 | 80,537 |
| Efficacy supplement (to an approved BLA under section 351 of the PHS Act) | 100 | 322,147 | 80,537 |
| Panel-track supplement | 75 | 241,610 | 60,403 |
| De novo classification request | 30 | 96,644 | 24,161 |
| 180-day supplement | 15 | 48,322 | 12,081 |
| Real-time supplement | 7 | 22,550 | 5,638 |
| 510(k) premarket notification submission | 3.40 | 10,953 | 2,738 |
| 30-day notice | 1.60 | 5,154 | 2,577 |
| 513(g) request for classification information | 1.35 | 4,349 | 2,175 |
| Annual Fee Type | |||
| Annual fee for periodic reporting on a class III device | 3.50 | 11,275 | 2,819 |
| Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device, as defined by 21 U.S.C. 379i(13)) | Base fee specified in statute | 4,884 | 4,884 |
On the biosimilar side, application fees in 2019 are the same as they were in 2018, but initial biosimilar biological product development fees declined from $227,213 in 2018 to $185,409 in 2019.
Reactivation fees (a fee to resume participation in a discontinued program) have also declined from $454,426 in 2018 to $370,818 in 2019, and program fees have stayed the same as in 2018.
“In FY 2019, FDA estimates 24 participants entering the BPD program, zero reactivations, and 63 participants to be invoiced for the annual BPD fee for a total of 87 participants in the BPD program in FY 2019,” the agency said.