News | July 30, 2018

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.

SOURCE: Regulatory Affairs Professionals Society