PDUFA, BUSUFA, ADUFA and AGDUFA User Fee Rates Announced

Four Federal register notices published today announce the FY 2017 user fee rates for the Prescription Drug User Fee Act (here) , the Biosimilar User Fee Act (here), the Animal Drug User Fee Act (here) and the Animal Generic Drug User fee Act (here).

PDUFA Fees for FY 2017

PDUFA pic 1

Biosimilar User Fees for FY 2017

PDUFA pic 2

 1 Under section 744H(a)(2)(A) of the FD&C Act, if a sponsor that submits a biosimilar biological product application has previously paid an initial BPD fee, annual BPD fees, and/or reactivation fees 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.


Animal Drug User Fee Rates for FY 2017

PDUFA pic 3


1An animal drug establishment if subject to only one such fee each fiscal year.

2An animal drug sponsor is subject to only one such fee each fiscal year.


Animal Generic Drug User Fee rates for FY 2017

PDUFA pic 4


Some observations:

  • The PDUFA Application Fee had dropped about $300,000 for FY 2017. The first PDUFA application fee drop this 5 year cycle.
  • BSUFA Application Fees had also dropped because they track the PDUFA fees.
  • Animal Drug User Fees are essentially the same- some slightly up, some slightly down. Largest increases come in the Establishment Fee and Product Fees
  • Animal Generic Drug Use Fees are esentially the same- some up, some down. Largest increase come in the Sponsor Rates (which are all up significantly) and the Product Fee.

There is a lot of information in the FR notices relative to the calculation of the new fees and what factors have resulted in increases or decreases in the individual fees.  I suggest you place copies of the FR Notices on your bedside table and if you have trouble sleeping, just pick on up and read it cover to cover (if you last that long)! Who needs Ambien?