Well, who will be changing categories (small, medium, and large) for assessment of year two of GDUFA II program fees? The FDA asks “[i]n preparation for the FY 2019 GDUFA Generic Drug Applicant Program Fee, please confirm your affiliates and approved ANDAs owned by you and your affiliates as soon as possible.”
In the first 7 months of FY 2018, firms have withdrawn 333 approved ANDAs, which is a staggering number of approved ANDAs and we believe that much of this is in an effort to trim down some of the “no longer marketed but approved” applications that count towards the fee category calculation. Prior to the institution of the program fee, firms just kept discontinued applications on the books and treated them as assets; now those assets could cost some firms big bucks .Don’t forget that even ANDAs in the discontinued section impact that ANDA count…and that means that you are already most likely out of time to do something about it, as FDA explains for “FY 2019 through FY 2022, an ANDA shall be deemed not to be approved if the applicant has submitted a request for withdrawal of approval of such ANDA by April 1 of the previous fiscal year.”
The FDA also has provided some other facts about the program fee (here), along with the current list for your firm to use as a check and reference.
As a reminder, the program fee is due on October 1, 2018 (the beginning of FY 2019), unless if that date falls on a weekend or holiday. ANDAs approved after October 1 will be included on the firm’s list for FY 2020. The FDA notes that fees not paid within 20-days of the due date will result in 1) the firm’s addition to the arrears list, 2) OGD refusing-to receive any new ANDAs, 3) all of the firms approved products being deemed misbranded.
Also, FDA reminds firms that affiliates result in additive totals, for the purpose of assessing the program fee so you can segregate the number of ANDAs with the hope of paying a small fee and a medium fee. Timing of transfers and consolidations (e.g. combining multiple strengths of the same product ANDAs into one) must occur in time for OGD to process the changes prior to October 1 of each year, or they will be counted against your calculation.
There are a few other tidbits on the link above to remind sponsors of other things to consider with regards to the program fee. So, take some time now and check the accuracy of the lists so you don’t get a surprise on October1.