Fee-for-all: FDA issues FY 2016 user fee rates

Eight notices regarding fiscal year (FY) 2016 user fees, rates, and payment procedures for prescription drugs, animal drugs, biosimilars, foods, medical devices, and human drug compounding outsourcing facilities were issued by the FDA. Under the federal Food, Drug, and Cosmetic Act (FDC Act), the FDA is authorized to set fees and schedules for these regulated areas. User fee programs provide revenue in support of the FDA’s efforts to oversee public safety, as well as foster industry innovation, in these regulated areas. The fees are effective October 1, 2015, and will remain in effect through September 30, 2016.

Prescription drugs

The FDC Act as amended by the Prescription Drug User Fee Amendments of 2012 (PDUFA V), authorizes the FDA to collect user fees for certain applications for the review of human drug and biological products, on establishments where the products are made, and on such products (Notice, 80 FR 46028, August 3, 2015).

The fees were based on a net of 485 fee-paying establishments for FY 2016. At the beginning of FY 2015, the establishment fee was based on an estimate that 509 establishments would be subject to and would pay fees. With additional data, the FDA revised its numbers and estimated that 516 establishments will have been billed for establishment fees, before all decisions on requests for waivers or reductions are made by the end of FY 2015.

The FY 2016 fee for an application requiring clinical data is set at $2,374,200; for an application not requiring clinical data or a supplement requiring clinical data the FY 2016 is set at $1,187,100. In addition, establishment fees (based on estimated 485 establishments) are $585,200 per establishment. Product fees were set at $114,450 per product, based on an estimate of 2,480 products for FY 2016. Applications and supplements that are submitted on or after October 1, 2015, will use the new fee schedule; invoices for establishment and product fees for FY 2016 will be issued in August 2015 using the new fee schedule.

Generic drugs

Based on granted authority by the Generic Drug User Fee Amendments of 2012 (GDUFA), effective October 1, 2015, through September 30, 2016, fees for abbreviated new drug applications (ANDA), prior approval supplements to an approved ANDA (PAS), and drug master files (DMF) will increase in FY 2016 over the corresponding FY 2015 fees because of a drop in the number of submissions in each of those three categories (Notice, 80 FR 46015, August 3, 2015). For FY 2016, the generic drug fee rates for these three classes are as follows: $76,030 for ANDAs; $38,020 for PAS; and $42,170 for DMF.

For active pharmaceutical ingredient (API) facilities, FY user fees are set at $40,867 for domestic facilities and $55,867 for foreign facilities. Similarly finished dosage form (FDF) fees are lower for domestic facilities versus foreign facilities, with the former set at $243,905 and the latter at $258,905.

Animal drugs

Section 740 of the FDC Act establishes four different types of user fees: (1) fees for certain types of animal drug applications and supplements; (2) annual fees for certain animal drug products; (3) annual fees for certain establishments where such products are made; and (4) annual fees for certain sponsors of animal drug applications and/or investigational animal drug submissions.

For FY 2016, the animal drug user fee rates are: $351,100 for an animal drug application; $175,550 for a supplemental animal drug application for which safety or effectiveness data are required and for an animal drug application subject to the criteria set forth in Section 512(d)(4) of the FDC Act; $7,790 for an annual product fee; $105,950 for an annual establishment fee; and $101,000 for an annual sponsor fee.

Under authority by the Animal Drug User Fee Amendments of 2013 (ADUFA III), the FDA determined the fee revenue to be generated by animal drug establishment fees in FY 2016 on an estimation that 12 percent of establishments invoiced will not pay fees in FY 2016 because of waivers or reductions. Based on historical data of the last five completed years prior to FY 2016 the will result in 56 establishments subject to fees in FY 2016.

Generic animal drugs

The FDC Act, as amended by the Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs.

For FY 2016, the generic new animal drug user fee rates are: $233,300 for each abbreviated application for a generic new animal drug other than those subject to the criteria in Section 512(d)(4) of the FDC Act; $116,650 for each abbreviated application for a generic new animal drug subject to the criteria in Section 512(d)(4); $8,705 for each generic new animal drug product; $83,800 for each generic new animal drug sponsor paying 100 percent of the sponsor fee; $62,850 for each generic new animal drug sponsor paying 75 percent of the sponsor fee; and $41,900 for each generic new animal drug sponsor paying 50 percent of the sponsor fee.

The FDA will issue invoices for FY 2016 product and sponsor fees by December 31, 2015; the fees are due January 31, 2016.

Biosimilars

The Biosimilar User Fee Act of 2012 (BsUFA), authorizes the FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development (BPD), certain applications and supplements for approval of biosimilars, establishments where approved biosimilars are made, and a biosimilar fee for each biosimilar approved in a biosimilar application.

The FY 2016 fee for a biosimilar application requiring clinical data equals the PDUFA fee for an application requiring clinical data is $2,374,200; for biosimilars not requiring clinical data the rate is halved to $1,187,100 (Notice, 80 FR 46005, August 3, 2015). However, under Section 744H(a)(2)(A) of the FDC Act, if a sponsor submitting a biosimilar application has previously paid an initial BPD fee, annual BPD fee(s), and/or reactivation fee(s) for the product that is the subject of the application, the fee for the application is reduced by the cumulative amount of these previously paid fees. Biosimilar supplement with clinical data fees are also set at $1,187,100. Establishment fees are set at $585,200, and product fees are $114,450.

The initial BPD fee for a product is due when the sponsor submits an investigation new drug application that FDA determines is intended to support a biosimilar application for the product or within 5 calendar days after FDA grants the first BPD meeting for the product, whichever occurs first. Sponsors who have discontinued participation in the BPD program must pay the reactivation fee.

Food Safety Modernization Act

For FY 2016 fee rates authorized by the FDC Act, as amended by the FDA Food Safety Modernization Act (FSMA) (P.L. 111-353) were established for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections (Notice, 80 FR 46020, August 3, 2015). Section 107 of FSMA added Section 743 to the FDC Act to provide the FDA with the authority to assess and collect fees from, in part: (1) the responsible party for each domestic facility and the U.S. agent for each foreign facility subject to a reinspection, to cover reinspection-related costs; (2) the responsible party for a domestic facility and an importer who does not comply with a recall order, to cover food recall activities associated with such order; and (3) each importer subject to a reinspection to cover reinspection-related costs.

Fees of $221 per paid hour and $315 per paid hour will be incurred for domestic inspection travel and foreign inspection travel, respectively. Types of activities could include conducting recall audit checks, reviewing periodic status reports, analyzing the status reports and the results of the audit checks, conducting inspections, traveling to and from locations, and monitoring product disposition.

Medical devices

Section 738 of the FDC Act establishes fees for certain medical device applications, submissions, supplements, and notices (collectively known as submissions). The fee rate for each type of submission is set at a specified percentage of the standard fee for a premarket application, which is a premarket approval application (PMA), a product development protocol (PDP), or a biologics license application (BLA). The base fee for a premarket application for FY 2016, which apply from October 1, 2015, through September 30, 2016, is set as $263,180 (Notice, 80 FR 46033, August 3, 2015). The annual fee for establishment registration, after adjustment, is set at $3,845 for FY 2016. There is no small business rate for the annual establishment registration fee; all establishments pay the same fee.

Businesses with gross receipts or sales of no more than $100 million for the most recent tax year may qualify for reduced small business fees. Businesses with gross sales or receipts of no more than $30 million may also qualify for a waiver of the fee for the first premarket application (PMA, PDP, or BLA) or premarket report. All businesses must include the gross receipts or sales of all affiliates along with own gross receipts or sales when determining whether the $100 million or $30 million threshold is met.

Compounding facilities

The FY 2016 fees related to human drug compounding outsourcing facilities electing to register under Section 503B of the FDC Act are: $5,203 for small business establishments; $16,465 for non-small business establishments; and $15,610 for reinspection of a facility.

Outsourcing facilities that registered in FY 2015 and wish to maintain their status as an outsourcing facility in FY 2016 must register during the annual registration period that lasts from October 1, 2015, to December 31, 2015.