We all are aware of the new fee schedule for GDUFA II which include:
- ANDA application
- DMF application
- Facility fees, both API and FDF
- ANDA holder fee
Timeline for payment of the fees for ANDAs is at the time of submission of the ANDA. Payment of the annual Program Fee, Facility Fees for both API and FDF is October 1st of each fiscal year. There is a 20 business day grace period for payment of the program fees. Thus, the October 23, 2017 date for payment of the annual program fee looms large. Why? If the annual fees are not paid on time then your firm will be in arrears and any ANDA submitted but not yet filed (remember OGD received 202 ANDAs in September) will receive a refuse-to-receive letter if that fee is not paid when the ANDA comes up for acceptance evaluation.
As Lisa Parks of AAM noted in an email to one of the AAM working groups:
You will also know that the annual fees are due on Oct 1 of each new fiscal year. The GDUFA statute does allow a “grace period” of 20 days from the start date of each fiscal year for firms to pay these fees before penalties are applied (e.g., RTR-ing an ANDA). So what does all this mean and why are these dates of significance? Let me run through an example to illustrate:
- FDA posted the FY2018 fees in Aug 2017.
- Industry has until Oct 23 (since October 1 was a Sunday, it is 20 days from the first business day, or: October 2 + 20 = October 22, which is also a Sunday, so October 23) to pay the fee obligations, in this case the annual fee since the one-time fees, a.k.a. application fees, are paid at time of submission.
- If the annual fee obligation is not met by Oct 23, the ANDA sponsor and its affiliates will receive fee-related RTRs for any applications submitted that have not yet been ‘received’ by the Agency.
- Fee related RTR = no refund of the application fee paid, the ANDA sponsor has to pay the new FY2018 fee if it resubmits the ANDA, and the sponsor loses the submission date.
- Once the sponsor meets the fee obligation by paying its fees, the ANDA will be eligible for assessment by OGD’s Division of Filing Review and the submission date will be readjusted to reflect the date the fee obligation was met.
Why is this fact important…since it has been reported by various news media, OGD received a record number of submission in September. Knowing that OGD has approximately 60 days to make a filing determination, the above-scenario could compromise your submission date, as well as the application fee you paid in September (or, for that matter, any time prior to Oct 1) for any ANDA for which you have not yet received a filing determination.
So, the bottom line is – please make sure your company has paid all of its annual fee obligations to avoid unnecessary headaches. And just to reiterate, the annual fees are API and FDF facility fees, and the ANDA holder fee.
Don’t be complacent – pay the fees or you will likely be answering to your CEO and Board of Directors. This is very important as the October date is very close and any first-to-file opportunity could be lost for failure to assure annual fee payments are received by FDA on time.