As we previously reported (here), OGD approved 61 ANDAs and Tentatively Approved 6 ANDAs in November; thus there was appositive reduction of 24 applications in the theoretical backlog.
Look more at the trend in approval, and, while we are early in FY 2015, there has been receipts in the range of about 40-50 per month over the last few months. Having said that, is it reasonable to expect that the Office of Generic Drugs (OGD) will only be expected to receive between 480-600 ANDAs for FY 2016? If so, be prepared for a substantial increase in application fees for GDUFA FY 2017.
This is (somewhat) the good news and the bad news. The good news is that OGD should have substantive excess review resources available, based on a reduced number of applications received. The bad news is-you are going to pay more for fewer applications.
We have certainly seen significant consolidation in the generics industry. This also means potentially fewer facilities being charged fees. I hope we are not going to break the bank and wind up with double digit fee increases each year of GDUFA. I am certain that the asks for GDUFA II are going to result in higher fees because nobody does something for nothing! Good luck, folks!
