Rising to New Heights (And Sinking to New Lows): PDUFA, BsUFA, and GDUFA Fiscal Year 2015 User Fee Rates . . . And More

By Kurt R. Karst

For several years now we’ve closely tracked the changes in user fees rates FDA sets each fiscal year under the Prescription Drug User Fee Act (“PDUFA”). Last year, we added rates set pursuant to the Generic Drug User Fee Amendments of 2012 (“GDUFA”) and the Biosimilar User Fee Act of 2012 (“BsUFA”) (see our previous post here). This year we’re a little late reporting on the Fiscal Year 2015 (“FY 2015”) rates established by FDA earlier this month . . . but with good cause. While FDA was busy ascending on some user fee rates and descending on other user fee rates, this blogger was busy doing his own ascending and descending – up to and down from the summit of Mt. Kilimanjaro in Tanzania, Africa. And while we were at the summit (Uhuru Peak, at 19,341 feet), we staked a claim for Hyman, Phelps & McNamara, P.C. Here’s proof if you need it:

The FY 2015 PDUFA application user fee rate is set at $2,335,200 for an application requiring “clinical data” (defined here in an FDA guidance document), and one-half of a full application fee ($1,167,600) for an application not requiring “clinical data” and a supplement requiring “clinical data.” FDA’s Federal Register notice announcing the new rates is available here. These figures reflect FDA’s estimate of 115.042 fee-paying full application equivalents – an average of the number of full applications that paid fees over the lateset 3 years. This figure is slightly lower than last year’s estimate of 116.333 fee-paying full application equivalents and explains somewhat the increase in the application fee rate. Annual establishment and product fees have been set at $569,200 and $110,370, respectively, and are based on estimates of 472 establishments (an increase of 17 compared to FY 2014) and 2,434 products (an increase of 9 compared to FY 2014).

The FY 2015 PDUFA user fee rates become effective on October 1, 2014 and generally represent a modest change vis-à-vis the FY 2014 user fee rates. All BsUFA user fees – i.e., the initial and annual biosimilar Biological Product Development (“BPD”) fees, the reactivation fee, and the biosimilar biological product application, establishment, and product fees – are keyed to PDUFA user fees. The FY 2015 rates have thus been set at $233,520 (initial and annual PBD), $467,040 (reactivation), $2,335,200 (application), $569,200 (establishment), and $110,370 (product). FDA’s Federal Registernotice announcing the new rates is available here.

The table below shows the changes in PDUFA user fee rates for the latest iteration of the law – PDUFA V. Hisorical tables for user fee rates changes since the enactment of PDUFA are avilable here.

GDUFA establishes several types of user fees that together generated $299 million in funding for FDA in FY 2013 (including $50 million from the one-time ANDA backlog fee). That $299 million base amount is adjusted annually, and in FY 2015 has been set at $312,224,000. (The FY 2014 adjusted base figure was $305,659,000.) Several of the FY 2015 GDUFA user fee rates FDA announced earlier this month, and which go into effect this October, are peddled back vis-à-vis the FY 2014 user fee rates; however, the Active Pharmaceitical Ingredient (“API”) and Finished Dosage Form (“FDF”) facility fee rates did take a hike up vis-à-vis the FY 2014 user fee rates.

The original ANDA and PAS fees, which make up 24% of the $312,224,000 (or $74,934,000 rounded to the nearest thousand dollars), are based on a total number of 1,276 fee-paying full application equivalents expected to be received in FY 2015. Dividing $74,934,000 by the total number of fee-paying full application expedted to be received results in an original ANDA fee of $58,730 and a PAS fee of $29,370 for FY 2015. The 1,276 fee-paying full application equivalents figure FDA identifies is significantly higher than the 1,148.8 figure used in FY 2014, and therefore, largely explains a drop in the original ANDA and PAS fees. Interestingly, that figure is an estimate of ANDAs that excludes the massive bolus of applications submitted in June 2014, before FDA’s enhanced ANDA stability requirements went into effect. That bolus – any any bolus of applications submitted when the GDUFA performance goals go into effect in October 2014 – will be reflected in future user fee figures, and could lead to user fee rate decreases over the following years.

The Drug Master File (“DMF”) fee, which makes up 6% of the $312,224,000 ($18,734,000 rounded to the nearest thousand dollars), is based on an estimate of 701 fee-paying DMFs in FY 2015 – a significant increase over the 583 fee-paying DMFs estimated for FY 2014. The resulting fee is $26,720 for FY 2015, which is a drop from the $31,460 user fee rate set for FY 2014.

The API and FDF facility fees are based on data submitted by generic drug facilities through the self-identification process. The FDF facility fee revenue makes up 56% of $312,224,000 ($174,845,000 rounded to the nearest thousand dollars), and the API facility fee makes up 14% of $312,224,000 ($43,711,000 rounded to the nearest thousand dollars). According to FDA, the total number of FDF facilities identified through self-identification was 681 (271 domestic and 410 foreign), and the total number of API facilities identified through self-identification was 795 (103 domestic and 692 foreign). These numbers translate into FY 2015 FDF facility fee rates of $247,717 for a domestic facility and $262,717 for a foreign facility, and API facility rates of $41,926 for a domestic facility and $56,926 for a foreign facility. These are pretty hefty increases compared to the FY 2014 FDF and API facility user fee rates, and are likely explained by the significant decrease in self-identified facilities. In FY 2014, the number of self-identified facilities used to calculated the facility fee rates was 748 (315 domestic and 433 foreign) FDF facilities, and 903 (128 domestic and 775 foreign) API facilities.

The table below shows the changes in GDUFA user fee rates for the first iteration of the law.