The schedules for the 2023 Prescription Drug User Fees (PDUFA) (here), Biosimilar User Fees (BSUFA) (here), and Medical Device User Fees (MDUFA) (here) have been posted and are scheduled for final publication on October 7, 2022.  However, the Generic Drug User fees (GDUFA) FR Notice has a stark word “WITHDRAWN” on the prepublication page with the following “Editorial Note: The agency withdrew this document after it was placed on public inspection.  This record will remain on display through the close of business on Friday, October 7, 2022.  A copy of the withdrawal request is available for inspection at the Office of the Federal Register.”  It is not clear why the generic fees did not appear today but we will keep you posted with any new information when it becomes available.

In the meantime, here are the FY 2023 user fees for the other three UFA programs.

2023 PDUFA Fees with 2022 Fees for Comparison

Fee Category FY 2022 Fee Rate FY 2023 Fee Rate Change
Application Requiring Clinical Data $3,117,218 $3,242,026 +124,808
Application No Clinical Data $1,558,609 $1,621,013 +62,404
Program Fees* $369,413 $393,933 +24,520

* Max up to five program fees (one for each strength) for each application

The FR notice notes:

“FDA will issue invoices and payment instructions for FY 2023 program fees under the new fee schedule in October 2022.  Under section 736(a)(2)(A)(i) of the FD&C Act, prescription drug program fees are generally due on October 3, 2022.  However, given the late date of the PDUFA reauthorization, invoices should be paid within 30 days of invoice.

FDA will issue invoices in December 2023 for products that qualify for FY 2023 program fee assessments after the October 2022 billing.”

2023 BSUFA Fees with 2022 Fees for Comparison

Fee Category FY 2022 Fee Rate FY 2023 Fee Rate Change
Initial BPD $57,184 $47,325 -$9,859
Annual BPD $57,184 $47,325 -$9,859
Reactivation $114,368 $94,650 -$19,718
Applications
Requiring Clinical Data $1,746,745 $1,746,745 0
Not Requiring Clinical Data $873,373 $873,373 0
Program $304,162 $304,162 0

Good news for the biosimilars program where all fees either decreased or stayed the same, presumably because there are more biosimilar submissions being made and the cost is spread over those submissions.  The FR prepublication notice also contains the following notation:

“FDA will issue invoices with payment instructions for FY 2023 annual BPD and program fees under the new fee schedule in October 2022.  Under sections 744H(a)(1)(B)(ii) and 744H(a)(3)(B) of the FD&C Act, annual BPD and program fees are generally due on October 3, 2022.  However, given the late date of the BsUFA reauthorization, invoices should be paid within 30 days of invoice.  FDA will issue invoices in December 2023 for any products that qualify for the annual program fee after the October 2022 billing.”

2023 MDUFA Fees with 2022 Fees for Comparison

Application Fee Type FY 2022
Standard Fee		 FY 2022
Small Business Fee		 FY 2023
Standard Fee		 FY 2023
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, or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act)
(42 U.S.C. 262))		 $374,858 $93,714 $441,547 $110,387
Premarket report
(submitted under section 515(c)(2) of the FD&C Act)		 $374,858 $93,714 $441,547 $110,387
Efficacy supplement
(to an approved BLA under section 351 of the PHS Act)		 $374,858 $93,714 $441,547 $110,387
Panel-track supplement $281,143 $70,286 $353,238 $88,309
De novo classification request $112,457 $28,114 $132,464 $33,116
180-day supplement $56,229 $14,057 $66,232 $16,558
Real-time supplement $26,240 $6,560 $30,908 $7,727
510(k) premarket notification submission $12,745 $3,186 $19,870 $4,967
30-day notice $5,998 $2,999 $7,065 $3,532
513(g) request for classification information $5,061 $2,530 $5,961 $2,980
Annual Fee Type
Annual fee for periodic reporting on a class III device $13,120 $3,280 15,454 $3,864
Annual establishment registration fee $5,672 $5,672 $6,493 $6,493

As you can plainly see, all of the MDUFA fees increased (some significantly) for FY 2023, adding to the cost of doing business with the FDA.  It’s interesting that the statement that appeared in both the PDUFA and BSUFA FR notices regarding the delay in issuance of the notice of the fee schedules (due to congressional delay in passing the reauthorization of the UFAs) doesn’t seem to appear in the MDUFA notice.

So, now you can get out your checkbooks and be prepared to pay your “fair” share of the review costs for FY 2023 submissions!