Health Law Daily FY 2017 user fee rates issued for Rx and animal drugs, biosimilars
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Thursday, July 28, 2016

FY 2017 user fee rates issued for Rx and animal drugs, biosimilars

By Harold Bishop, J.D.

Four notices setting forth the fiscal year (FY) 2017 user fees, rates, and payment procedures for prescription drugs, animal drugs, animal generic drugs, and biosimilars have been issued by the FDA. Under the federal Food, Drug & Cosmetic Act (FDC Act), the FDA is authorized to set fees and schedules for these regulated areas. The user fees provide revenue in support of the FDA’s efforts to review applications, oversee public safety, and foster industry innovation in these regulated areas. The fees will be effective October 1, 2016, and will remain in effect through September 30, 2017.

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.

For FY 2017, the user fees rates will be: $2,038,100 for applications requiring clinical data; $1,019,050 for applications not requiring clinical data or supplements requiring clinical data (one-half the amount of applications requiring clinical data rate); $512,200 for establishments; and $97,750 for products (81 FR 49674, July 28, 2016).

The FY 2017 application fee must be paid for any application or supplement that is received on or after October 1, 2016. The FDA will issue invoices for establishment and product fees for FY 2017 in August 2016. Payment will be due on October 1, 2016. The FDA will also issue invoices in November 2017 for any products and establishments subject to fees for FY 2017 that qualify for fee assessments after the August 2016 billing.

Animal drugs. The FDC Act, as amended by the Animal Drug User Fee Amendments of 2013 (ADUFA III), authorizes the FDA to collect user fees for animal drug applications and supplements, for animal drug products, for establishments where such products are made, and for sponsors of such animal drug applications and investigational animal drug submissions.

For FY 2017, the animal drug user fee rates will be: $350,700 for an animal drug application; $175,350 for a supplemental animal drug application for which safety or effectiveness data are required or for an animal drug application with more than one active ingredient or where the labeling recommends use of the drug in combination with one or more approved animal drugs, as required by section 512(d)(4) of the FDC Act (21 U.S.C. §360b(d)(4)); $8,195 for an annual product fee; $111,900 for an annual establishment fee; and $103,100 for an annual sponsor fee (81 FR 49664, July 28, 2016).

The FDA will issue invoices for FY 2017 product, establishment, and sponsor fees by December 31, 2016, and payment will be due by January 31, 2017. Applications will not be accepted for review until the FDA has received full payment of application fees and any other animal drug user fees owed under the ADUFA program.

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

For FY 2017, the generic new animal drug user fee rates will be: $232,400 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 (21 U.S.C. §360b(d)(4)); $116,200 for each abbreviated application for a generic new animal drug subject to the criteria in section 512(d)(4); $10,200 for each generic new animal drug product; $96,350 for each generic new animal drug sponsor paying 100 percent of the sponsor fee; $72,263 for each generic new animal drug sponsor paying 75 percent of the sponsor fee; and $48,175 for each generic new animal drug sponsor paying 50 percent of the sponsor fee (81 FR 49669, July 28, 2016).

The FDA will issue invoices for these FY 2017 product and sponsor fees by December 31, 2016. The fees will be due by January 31, 2017. The application fee rates are effective for all abbreviated applications for a generic new animal drug submitted on or after October 1, 2016.

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

BsUFA directs the FDA to establish, before the beginning of each FY, the initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application, establishment, and product fees.

Under BsUFA, the initial and annual BPD fees equal 10 percent of the PDUFA fee for an application requiring clinical data, and the reactivation fee equals 20 percent of the PDUFA fee for an application requiring clinical data. The FY 2017 fee for an application requiring clinical data under PDUFA is $2,038,100 (see above). Therefore, multiplying the PDUFA application fee, $2,038,100, by 0.1 results in FY 2017 initial and annual BPD fees of $203,810. Multiplying the PDUFA application fee, $2,038,100, by 0.2 results in a FY 2017 reactivation fee of $407,620 (81 FR 49681, July 28, 2016).

In addition, for FY 2017, the biosimilar user fees will be: $2,038,100 for applications requiring clinical data (the same as the rate for prescription drugs); $1,019,050 for applications not requiring clinical data and supplements with clinical data (one-half the full application rate); $512,200 for establishments where approved biosimilar biological products are made; and $97,750 for each approved biosimilar biological product.

The initial BPD fee for a product is due when the sponsor submits an investigational new drug application (IND) that the FDA determines is intended to support a biosimilar biological product application for the product or within five calendar days after the 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 by the earlier of the following dates: (1) no later than five calendar days after the FDA grants the sponsor’s request for a BPD meeting for that product; or (2) upon the date of submission of an IND describing an investigation that FDA determines is intended to support a biosimilar biological product application.

The application or supplement fee for a biosimilar biological product is due upon submission of the application or supplement. The FDA will issue invoices for annual BPD, biosimilar biological product establishment, and biosimilar biological product fees under the new fee schedule in August 2016. Payment instructions will be included in the invoices. Payment will be due on October 1, 2016.

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