The GDUFA II Program Fee Estimates – Gulp!

Today, FDA announced the current data they are collecting from which the “Program Fee” will ultimately be calculated for the three tiers of approved application holders.  And while it is really not much of a surprise, based on some back of the envelope calculations we have done in the past, it may be a bit of a shock to some in the medium and highest tiers.  In addition, there is a table listing about 20 applicants with first time ANDAs (1 or 2 approved applications); we hope that these applicants are aware of the need to pay this program fee when GDUFA II kicks in.

FDA has been collecting data from firms and cleaning up its database in preparation for announcing the official fees in August, which will go into effect with the October 1, 2017 effective date of GDUFA II.  In review of the data collected, it appears that as of April 7, the number of sponsors for small, medium, and large tiers with associated fees per tier were as follows, along with “a back of the envelope calculation” based on the total fees FDA will collect under the Program Fee initiative:

Tiers                                                 Number of Sponsors

  • Small (1-5 approved ANDAs)                     383 sponsors; $130,780
  • Medium (6-19 Approved ANDAs)              72 sponsors; $523,120
  • Large (20 or more approved ANDAs)        65 sponsors; $1,307,800

 

These estimates were based on data through Friday April 7, 2017.  The actual fee amounts will likely change somewhat as new approvals issue over the next two to three months.  In addition, firms could review their approved applications and decide to withdraw some ANDAs that may move them down to a lower tier.  If a firm is on the border of a tier and there is an asset that might not be worth keeping, it may be prudent to withdraw the application.  Kind of like a garage sale where someone buys something that you were planning on throwing away otherwise.

 

Remember that the fee amounts you calculate today based on the information FDA is providing today will likely not match the fee amounts published August in the official Federal Register announcement, although for all intents and purposes, they will be in the same ballpark.

 

It appears that firms have done a good job in providing the clean-up information that FDA was seeking and, therefore, FDA will not likely need to do a second Federal Register posting for the clean-up effort, although they are welcoming and accepting any additional information firms present.  There are, however, a number of unclaimed ANDAs.  Firms need to pay particular attention to this list because, if they are not claimed or disposed of (withdrawn or corrected as to current sponsor), then a US government obligation will likely be incurred, and there could be consequences for non-payment.   To view all the information FDA has released today please click here.

 

Update to this information and the final official fees will be posted as they become available.