In a Federal Register Notice to be published tomorrow (here), the FDA announced GDUFA User Fees that will be in effect for Fiscal Year 2020, which begins on October 1, 2019 and continues through September 30, 2020.  There is some good news and some bad news.

Here are the application, DMF, and facility fees for FY 2020 compared to the 2019 fees:









As you can see, there was a slight decrease in the application fee of $2,562, and a very slight increase ($214) for both domestic and foreign API facilities.  All other fees have slightly increased, and remember these new fees take into consideration inflations costs!  So THAT is the good news and the bad news all at once.

The FDA uses an interesting calculation for estimating the number of fee-paying applications by taking into account not only those applications that are initially received but also those that may have been originally submitted but are subject of a refuse-to-receive action and later may be resubmitted during the same FY.  Remember that firms will lose 25% of their GDUFA application fee if the application received an RTR action but must pay the full fee when it is resubmitted.  By its calculation, FDA estimates that the OGD will receive 961 fee-paying equivalent applications in FY 2020.  The Federal Register goes into excruciating detail as to how each of the above fees are calculated so please read the full notice.

The big news comes in the allocation of the program fees for FY 2020:





*     Large:  20 or more ANDAs
**   Medium:  6-19 ANDAs
*** Small:  5 or fewer ANDAs

We see a fairly substantial decrease in the program fee for large manufacturers, meaning that some of the medium players have moved up in approval counts, placing them in the large group, and as more are pushed into the next higher level, the fees would normally go up because there are fewer in that category, but there must be new players in all the categories because all program fees have decreased. Where are all these new companies coming from?

So, this is where we sit for GDUFA fees for FY 2020.  Get your checkbooks out as October 1 is right around the corner.