FDA User Fees In FY 2014: Burden Per Application Grows As Submission Projections Fall

Agency announces new prescription drug, generic drug and biosimilar rates – with one fee increasing more than 47%.

FDA’s fiscal year 2014 user fee rates for the prescription drug, generic drug and biosimilar programs include some expected and unexpected increases, and also underscore the still-embryonic status of BsUFA.

Industry will once again pay more for application reviews, facility inspections and other agency services during the upcoming fiscal year. Fees across the three programs increased at least 5%, with the GDUFA drug master file fee jumping more than 47%, by far the most.

GDUFA charges increased in part because of an adjustment for inflation, but also to rebalance revenue generation to account for the loss of the backlog fee, which only was allowed in FY 2013 (Also see "Generic User Fees Jump To Cover Inflation Increase, Backlog Fee Elimination" - Pink Sheet, 1 Aug, 2013.).

FDA decided to change its formula for PDUFA workload adjustments after a contractor determined the method it had been using was not accurate. The main application fee will cross the $2 million threshold in FY 2014, thanks to a nearly 11% increase (Also see "PDUFA, Biosimilar Application Fees To Rise 10.7%; FDA’s Workload Adjuster Needs Work" - Pink Sheet, 1 Aug, 2013.).

Total revenue for two programs increased modestly. FDA calculated a 2% increase for GDUFA and a 5% increase for PDUFA. Total revenue was not estimated for BsUFA.

The increased fee revenue overall also should continue FDA’s growing dependence on it to meet budgetary needs, especially with sequestration forcing reductions (Also see "FDA’s Budget Proposal: It’s The User Fees’ Agency Now" - Pink Sheet, 15 Apr, 2013.). The agency lost user fee as well as treasury dollars when the mandatory budget cuts went into effect, but congressional efforts are under way to exempt fees going forward (Also see "FDA Sequestration Relief Bill In House Would Free User Fees, But “Pay For” Remains Question Mark" - Pink Sheet, 19 Jul, 2013.).

User Fee Amounts
Type	FY 2013	FY 2014	Change
Prescription Drug User Fee
Application requiring clinical data	$1.96 million	$2.17 million	$210,300 (10.7%)
Application not requiring clinical data or supplement requiring clinical data	$979,400	$1.08 million	$105,150 (10.7%)
Establishment	$526,500	$554,600	$28,100 (5.3%)
Product	$98,380	$104,060	$5,680 (5.8%)
Generic Drug User Fee
ANDA	$51,520	$63,860	$12,340 (24%)
Prior Approval Supplement	$25,760	$31,930	$6,170 (24%)
Drug Master File	$21,340	$31,460	$10,120 (47.4%)
Domestic Active Pharmaceutical Ingredient Facility	$26,458	$34,515	$8,057 (30.5%)
Foreign Active Pharmaceutical Ingredient Facility	$41,458	$49,515	$8,057 (19.4%)
Domestic Finished Dosage Form Facility	$175,389	$220,152	$44,763 (25.5%)
Foreign Finished Dosage Form Facility	$190,389	$235,152	$44,763 (23.5%)
Backlog (one-time fee only charged in FY 2013)	$17,434	N/A	N/A
Biosimilar User Fee
Product Development	$195,880	$216,910	$21,030 (10.7%)
Application Reactivation	$391,760	$433,820	$42,060 (10.7%)
Application Requiring Clinical Data	$1.96 million	$2.17 million	$210,300 (10.7%)
Application Not Requiring Clinical Data or supplement requiring clinical data	$979,400	$1.08 million	$105,150 (10.7%)
Establishment	$526,500	$554,600	$28,100 (5.3%)
Product	$98,380	$104,060	$5,680 (5.8%)
Note: Biosimilar fees are based on PDUFA fee rates for the fiscal year.
Total Revenue Estimates
PDUFA	$718.67 million	$757.03 million	$38.34 million (5.3%)
GDUFA	$299 million	$305.66 million	$6.66 million (2.2%)
Note: FDA did not give a total revenue estimate for the biosimilar user fee program
Submission Estimates
PDUFA
Fee-Paying Full Application Equivalents	122.3	116.3	-5.97 (-4.9%)
GDUFA
ANDA	850	911	61 (7.2%)
Prior Approval Supplement	576	480	-96 (-16.7%)
Drug Master File	700	583	-117 (16.7%)
Fee-Paying Full Application Equivalents	1,160	1,148.8	-11.2 (-1%)
Note: No submission volume estimates were given for the biosimilar user fee program
Source: FDA Federal Register notices published Aug. 2.