stack of one hundred dollars notes

PDUFA, ADUFA, AGDUFA and BsUFA Fees for FY 2020 Announced

In a series of four Federal Register Notices issued today, the FDA announced the fee structures for the last four UFAs for Fiscal Year 2020.

It is no surprise that the PDUFA fees are the highest overall in total, with well over $1 billion in potential collections.  The fees for each of the programs are presented in the tables below, along with links to the Federal Register notices.

Prescription Drug User Fees (PDUFA) Fees FY 2020 (here)

Fee Category Fee Rates for FY 2020 Fee Rates for FY 2019
Application requiring clinical data $2,942,965 $2,588,478
Application not requiring clinical data $1,471,483 $1,294,239
Program Fee* $325,424 $309,915

*   Maximum of five program fees per application (based on individual product strengths in each Application (previously called product fees)).

Animal Drug User Fees (ADUFA) FY 2020 (here)

Fee Category Fee Rates for FY 2020 Fee Rates for FY 2019
Animal Drug Application $440,446 $449,348
Supplemental Animal Drug Application for Which Safety or Effectiveness Data are Required or
Animal Drug Application Subject to the Criteria Set Forth in Section 512(d)(4) of the FD&C Act
$220,223 $224,674
Animal Drug Product Fee $11,353 $10,747
Animal Drug Establishment Fee1 $159,177 $146,038
Animal Drug Sponsor Fee2 $144,999 $125,990

1       An animal drug establishment is subject to only one such fee each fiscal year.

2       An animal drug sponsor is subject to only one such fee each fiscal year.

Animal Generic Drug User Fees (AGDUFA) FY 2020 (here)

Fee Category Fee Rates for FY 2020 Fee Rates for FY 2019
Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in Section 512(d)(4) $493,897 $424,444
Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in Section 512(d)(4) $246,949 $212,222
Generic New Animal Drug Product Fee $16,645 $15,486
100 Percent Generic New Animal Drug Sponsor Fee $172,329 $150,098
75 Percent Generic New Animal Drug Sponsor Fee $129,247 $112,574
50 Percent Generic New Animal Drug Sponsor Fee $86,165 $75,049

For AGDUFA, an animal drug sponsor is subject to only one fee each fiscal year.  The sponsor fee is based on the number of applications a sponsor has approved.  “Applicants with more than six approved abbreviated applications will pay 100 percent of the sponsor fee; applicants with more than one and fewer than seven approved abbreviated applications will pay 75 percent of the sponsor fee; and applicants with one or fewer approved abbreviated applications will pay 50 percent of the sponsor fee.”

Biosimilar User Fees (BsUFA) for FY 2020 (here)

Fee Category Fee Rates for FY 2020 Fee Rates for FY 2019
Initial Biological Product Development (BPD) $117,987 $185,409
Annual BPD $117,987 $185,409
Reactivation $235,975 $370,818
Application requiring clinical data $1,746,745 $1,746,745
Application not requiring clinical data $873,373 $873,373
Program Fee** $304,162 $304,162

** Program fees like in PDUFA are assessed for a maximum of five different strengths of product in the same application.

The product development fees are prior to approval as well as the reactivation fee, which is charged if there is a break in product development fees taken by the sponsor and the sponsor wishes to reactivate the application.

The UFAs each have a peculiarity in regard to fee assessment, collection, waiver provisions, etc.  Please be certain to fully review the FR notices applicable to each of the programs to have a complete understanding of how the program operates and your responsibilities under each program.  All of the new program fees begin on October 1, 2019 and are in effect through September 30, 2020, the government’s fiscal year.

We have provided you with a comparison of FY 2020 versus FY 2019 rates.  Many have gone up, some have stayed the same or gone down.  It is all a numbers game!

Each year five years, the FDA reviews the individual UFA programs in an effort to ensure the program meets the needs of the industry and the Agency.  The negotiations are often contentious, but the job gets done.  The FDA has simplified many of the programs based on its experience, and changes are likely in each five-year cycle as both parties need change.