The FY18 user fee schedule for the Generic Drug User Fees Amendments (GDUFA II) has been posted (PDF). This is the first year for which pure CMO facilities will pay a reduced facility fee: one-third of the fee for a non-CMO.
The CMO FDF facility fee for FY18 will be $70,362 for a US site, and $85,362 for a non-US site. A $15,000 foreign differential applies to all non-US facilities, for both FDF and API. This fee is a significant drop from FY17’s FDF fee of $258,646. The non-CMO FDF fee is $211,087 for a US site and $226,087 for an non-US site.
If the PBOA was not at the negotiating table and the GDUFA I fee formula was applied to GDUFA II’s fee base of $493,600,000, the FDF fee would have been in excess of $400,000 per facility.
Under GDUFA II, CMO sites are defined as facilities that are not referenced in any APPROVED ANDAs held by the owner of that facility or its affiliates. So if your parent company owns an approved ANDA and it references your site, that site does not get the reduced fee.
There were several other changes to the GDUFA II fee formula. Be careful when fee collections begin, and ask for help if you’re unsure of the status of your facilities. We’re here to answer questions for our member companies.
FDF and API facilities that are not referenced in ANY APPROVED ANDAs are not charged a facility fee for that year. Note that “APPROVED” does not mean “ACTIVE”; if an ANDA references your site but you haven’t manufactured it in [x] years, your site remains subject to a facility fee. If your facility is referenced in a PENDING ANDA but no APPROVED ones, that facility is not subject to a facility fee.
Sites that do quality as both API and FDF facilities will only pay the higher of the two; under GDUFA I, they paid both sets of fees.
This year also introduces an ANDA Holder Fee, also known as a Program Fee. This fee has three tiers: entities that hold 20+ APPROVED ANDAs, entities that hold 6-19 APPROVED ANDAs, and entities that hold 1-5 APPROVED ANDAs. ANDAs pending approval are not added to this count, just as facilities that are only referenced in pending ANDAs are not subject to a facility fee.
Here is the breakdown of GDUFA II fees for FY18, which begins October 1:
Recurring Fees
FDF facility fee, US, non-CMO: $211,087
FDF facility fee, ex-US, non-CMO: $226,087
FDF facility fee, US, CMO: $70,362
FDF facility fee, ex-US, CMO: $85,362
API facility fee, US: $45,367
API facility fee, ex-US: $60,367
ANDA Holder fee, 1-5 approved ANDAs: $159,079
ANDA Holder fee, 6-19 approved ANDAs: $636,317
ANDA Holder fee, 1-5 approved ANDAs: $1,590,792
One-Time Fees
ANDA filing fee: $171,823
DMF filing fee: $47,829
Here are the rates that GDUFA II is based on:
Total FY18 fee base: $493,600,000
ANDA filing fees: 33%
DMF filing fees: 5%
API facility fees: 7%
FDF facility fees: 20%
ANDA Holder fees: 35%
Visit FDA’s GDUFA page to find out more about the fees, the self-ID process, the agency’s commitments under GDUFA II, and more. Download the fee announcement PDF.
Please contact me if you have questions about the fees or are interested in joining the PBOA.
About the PBOA
Founded in 2014, the Pharma & Biopharma Outsourcing Association (PBOA) is a nonprofit trade association dedicated to advancing the regulatory, legislative and general business interests of Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs). PBOA members provide the services that help the pharma and biopharma industry develop and manufacture drugs, biologics, vaccines, and other treatments safely and cost effectively. For more information about the PBOA, its members, and its mission, please visit www.pharma-bio.org. Follow PBOA on Twitter at @PBOAssoc.
For more information:
Gil Roth
President, PBOA
gil.roth@pharma-bio.org
201-788-7994
