The new GDUFA fees for 2016 were published today in the Federal Register (here) and there were some real surprises. For instance, the ANDA fee (that we thought was going to decrease given the fact that 2014 saw a record 1465 ANDAs submitted) soared and apparently FDA is justifying that the fee increase is due to the lower number of ANDAs that have been submitted so far in 2015 (377 through June 2015 with a straight line projection at that rate of 502 to be submitted in FY 2015). The FR notice says that OGD is expecting 801 original ANDA submissions in FY 2016. It is a good thing that the large number of ANDAs received in FY 2014 are being factored into the calculation because, if the number they used was the projected 502 for 2015, then the fee would have soared to well over $100,000. Obviously, the prior approval supplement (PAS) fee also rose because that is tied to ½ of the ANDA fee regardless of the number of PASs actually submitted. DMF fees also went up substantially given a decrease in the number of new DMFs submitted. This is expected, as multiple firms will reference a single DMF.
On the good news side of the coin, the amounts for all facility fees have decreased slightly due to a larger number of facilities that have self-identified.
|FY2016||FY 2015||FY 2014||FY 2013|
The fees were also pushed up somewhat by the inflation factor that is required under the statute. Thus, the base of $299 million for the first FY of GDUFA has pushed up to just over $318 million for FY 2015. Those inflationary costs also had to be spread across the total fee structure.
The new fees are effective for any submission received by FDA on or after October 1, 2015. Good luck, folks, it looks like the cost of doing business is generally going up. With all of the M&A activity, if the number of ANDAs continues to fall, the GUDFA II negotiations and ideas like waivers and small business exemptions may make sense to revisit.