By Kurt R. Karst –
Now that we've put the theme from The Jeffersons in your head . . . . On August 2, 2013, FDA will officially announce in a series of Federal Register notices the Fiscal Year 2014 (“FY 2014”) user fee rates under various user fee programs, including the Prescription Drug User Fee Amendments of 2012 (“PDUFA V”) (see here), the Generic Drug User Fee Amendments of 2012 (“GDUFA I”) (see here), the Biosimilar User Fee Act of 2012 (“BsUFA I”) (see here), the Medical Device User Fee Amendments of 2012 (“MDUFA III”) (see here), the Animal Generic Drug User Fee Amendments of 2013 (“AGDUFA II”) (see here), the Animal Drug User Fee Amendments of 2013 (“ADUFA III”) (see here), and the FDA Food Safety Modernization Act (“FSMA”) (see here). It will probably not come as a surprise to anyone that, as a general matter, the FDA-regulated industry will be expected to pay more in FY 2014 than in FY 2013. Below we focus on PDUFA, BsUFA and GDUFA user fees.
The FY 2014 PDUFA application user fee rate is set at $2,169,100 for an application requiring “clinical data,” and one-half of a full application fee ($1,084,550) for an application not requiring “clinical data” and a supplement requiring “clinical data.” (The term “clinical data” for PDUFA user fee purposes is explained in an FDA guidance document available here.) These figures reflect FDA’s estimate of 116.333 fee-paying full application equivalents – an average of the number of full applications that paid fees over the lateset 3 years. This figure is lower than last year’s estimate of 122.3 fee-paying full application equivalents and explains somewhat the increase in the application fee rate. Annual establishment and product fees have been set at $554,600 and $104,060, respectively, and are based on estimates of 455 establishments (the same as for FY 2013) and 2,425 products (a decrease of 10 compared to FY 2013).
The FY 2014 PDUFA fees go into effect on October 1, 2013 and represent a hefty change vis-à-vis the FY 2013 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 2014 rates have thus been set at $216,910 (initial and annual PBD), $433,820 (reactivation), $2,169,100 (application), $554,600 (establishment), and $104,060 (product).
As we have done in past years, we provide tables (below) showing the increase/decrease in PDUFA user fee rates since the previous FY for each fee type (and in this case for all FYs under PDUFA IV). The next set of tables illustrate the historical trend for each PDUFA user fee.
The FY 2014 GDUFA user fee rates are (as shown in the table below) significantly higher than the FY 2013 rates. Of course this was expected given the lack of an ANDA backlog fee in FY 2014. GDUFA establishes several types of user fees that together generated (not accounting for any sequestered fees paid - see Aug. 1, 2013 letter here) $299 million in funding for FDA in FY2013 (including $50 million from the ANDA backlog fee). That $299 million base amount is adjusted annually, and in FY 2014 has been set at $305,659,000. The FY2014 GDUFA fee rates go into effect on October 1, 2013.
The original ANDA and PAS fees, which make up 24% of the $305,659,000 ($73,358,000 rounded to the nearest thousand dollars), are based on a total number of 1,148.8 fee-paying full application equivalents expected to be received in FY 2014. The DMF fee, which makes up 6% of the $305,659,000 ($18,340,000 rounded to the nearest thousand dollars), is based on an estimate of 583 fee-paying DMFs in FY 2014.
The API (Active Pharmaceitical Ingredient) and FDF (Finished Dosage Form) facility fees are based on data submitted by generic drug facilities through the self-identification process (see here). The FDF facility fee revenue makes up 56% of $305,659,000 ($171,169,000 rounded to the nearest thousand dollars), and the API facility fee makes up 14% of $305,659,000 ($42,792,000 rounded to the nearest thousand dollars). According to FDA, the total number of FDF facilities identified through self-identification was 748 (315 domestic and 433 foreign), and the total number of API facilities identified through self-identification was 903 (128 domestic and 775 foreign). The number of self-identifying facilities used to calculate the FY 2013 facility fees is somewhat comparable to that in FY 2014. With respect to the FY2013 facility fees, FDA reported that 758 facilities (325 domestic and 433 foreign) self-identified as FDF facilities, and that 885 facilities (122 domestic and 763 foreign) self-identified as API facilities.