FDA unveils FY 2027 user fee rates
The US Food and Drug Administration (FDA) has published its user fee rates for FY 2027 across its prescription drug, generic drug, biosimilar, medical device, and over-the-counter drug programs. The rates are calculated by factoring in the agency’s resources against the number of applications it expects to receive over the next fiscal cycle based on historical trends.
PDUFA
FDA estimates the base revenue for FY 2027 for the Prescription Drug User Fee Amendment (PDUFA VII) at $1,515,410,160 before inflation and other factors are considered. The new estimate is almost a 6% increase compared to its FY 2026 estimate of $1,434,377,467.
|
PDUFA Fee Category |
FY 2026 Rates |
FY 2027 Rates |
Percentage Change |
|
Applications Requiring Clinical Data |
$4,682,003 |
$4,600,753 |
-1.7% |
|
Applications Not Requiring Clinical Data |
$2,341,002 |
$2,300,376 |
-1.7% |
|
Program |
$442,213 |
$416,857 |
-5.7% |
GDUFA
FDA estimates the base revenue for FY 2027 for the Generic Drug User Fee Amendment (GDUFA III) at $670,899,031 before considering inflation and other factors. The new estimate is more than a 5% increase compared to its FY 2025 estimate of $638,961,803.
|
GDUFA Fee Category |
FY 2026 Rates |
FY 2027 Rates |
Percent change |
|
ANDA |
$358,247 |
$375,684 |
4.9% |
|
Drug Master File |
$102,584 |
$109,899 |
7.1% |
|
Domestic API Facility |
$43,549 |
$39,680 |
-8.9% |
|
Foreign API Facility |
$58,549 |
$54,680 |
-6.6% |
|
Domestic FDF Facility |
$238,943 |
$230,033 |
-3.7% |
|
Foreign FDF Facility |
$253,943 |
$245,033 |
-3.5% |
|
Domestic CMO Facility |
$57,346 |
$55,208 |
-3.7% |
|
Foreign CMO Facility |
$72,346 |
$70,208 |
-3.0% |
|
Generic Drug Applicant - Large Firm |
$1,918,377 |
$1,927,291 |
0.5% |
|
Generic Drug Applicant - Medium Firm |
$767,351 |
$770,916 |
0.5% |
|
Generic Drug Applicant - Small Firm |
$191,838 |
$192,729 |
0.5% |
BsUFA
Based on what was agreed to under the Biosimilar User Fee Amendments (BsUFA III), FDA estimated that its base revenue from the program for FY 2027 needs to bring in $58,926,749 before being adjusted for inflation, hiring, operating costs, and other factors. That’s a 5.2% increase from the $56,011,943 base revenue that was projected by the agency for FY 2026.
FDA said it expects about 36 new biological product development (BPD) programs in FY 2027 with no reactivations. That is six more BPDs from its FY 2026 estimate of 30. It expects an additional 142 BPD programs to pay the annual BPD fee, up from 120 in FY 2026, which brings the total number of estimated applications to 178.
FDA lowered BsUFA fees by 18% last fiscal year and expects to lower them again by more than 6% next year.
|
BsUFA Fee Category |
FY 2026 |
FY 2027 |
Percent Change |
|
Initial BPD |
$10,000 |
$10,000 |
0.0% |
|
Annual BPD |
$10,000 |
$10,000 |
0.0% |
|
Reactivation |
$20,000 |
$20,000 |
0.0% |
|
Applications Requiring Clinical Data |
$1,200,794 |
$1,124,936 |
-6.3% |
|
Not Requiring Clinical Data |
$600,397 |
$562,468 |
-6.3% |
|
Program Fee |
$209,097 |
$195,887 |
-6.3% |
MDUFA
FDA estimates the base revenue for FY 2027 for the Medical Device User Fee Amendment (MDUFA V) at $418,343,000 before factoring in inflation and other factors. The new estimate is a 14% increase compared to its FY 2026 estimate of $366,486,300.
The following table shows the adjusted FY 2027 fees to meet FDA's revenue targets. The agency expects to increase rates by 10%.
|
MDUFA Application Type |
FY 2026 |
FY 2027 |
Percent Change |
|
Full Fee Applications |
$579,272 |
$636,732 |
10% |
|
- Small Business |
$144,818 |
$159,183 |
10% |
|
Panel-Track Supplement |
$463,418 |
$509,386 |
10% |
|
- Small Business |
$115,855 |
$127,347 |
10% |
|
De Novo |
$173,782 |
$191,020 |
10% |
|
- Small Business |
$43,446 |
$47,755 |
10% |
|
180-Day Supplement |
$86,891 |
$95,510 |
10% |
|
- Small Business |
$21,723 |
$23,878 |
10% |
|
Real-Time Supplement |
$40,549 |
$44,571 |
10% |
|
- Small Business |
$10,137 |
$11,143 |
10% |
|
510(k) |
$26,067 |
$28,653 |
10% |
|
- Small Business |
$6,517 |
$7,163 |
10% |
|
30-Day Notice |
$9,268 |
$10,188 |
10% |
|
- Small Business |
$4,634 |
$5,094 |
10% |
|
513(g) |
$7,820 |
$8,596 |
10% |
|
- Small Business |
$3,910 |
$4,298 |
10% |
|
Annual Periodic Reporting |
$20,275 |
$22,286 |
10% |
|
- Small Business |
$5,069 |
$5,572 |
10% |
OMUFA
FDA also published its Over-the-Counter (OTC) Monograph Drug User Fee Amendment (OMUFA II) program user fee rates for FY 2027. The agency set the FY 2027 base revenue, excluding certain adjustments, at $40,648,348, up 11.5% from the FY 2026 base revenue of $36,467,438. The agency published OTC monograph order (OMOR) request rates and monograph drug facility (MDF) and contract manufacturing organization (CMO) facility fee rates, which increased by almost 150%.
|
OMUFA Fee Category |
FY 2026 |
FY 2027 |
Percent Change |
|
MDF |
19,188 |
47,891 |
149.59% |
|
CMO |
12,792 |
31,927 |
149.59% |
|
Tier 1 OMOR fee |
587,529 |
614,608 |
4.61% |
|
Tier 2 OMOR fee |
117,505 |
122,921 |
4.61% |
