The GDUFA Fees for FY 2017 that go into effect October 1, 2016 were published today in the Federal Register (FR) (here). There are some interesting observations relative to the changes in the fees. Original ANDA application and Prior Approval Supplement fees dropped by almost $6,000 and $3000, respectively. While the number of ANDAs submitted in FY 2015 was the lowest ever during the first 5 years of GDUFA, the record 1473 ANDAs received in FY 2014 has certainly come into play in calculating the new ANDA fee for 2017, as FDA estimates an overall increase in submissions in FY 2017.
DMF fees rose about 17.6% over last year’s fees, due in part to fewer new DMFs being entered into the system. The slight decrease in Active Pharmaceutical Ingredient (API) and Finished Dosage Form (FDF) establishments reversed the dip we saw last year and rose to the highest level since the inception of GDUFA, due in part to a decrease in the number of facilities that self-identified for FY 2017.
| Fee | FY 2017 | FY 2016 | FY 2015 | FY 2014 | FY 2013 |
| ANDA fee | $70,480 | $76,030 | $58,730 | $63,860 | $63,860 |
| PAS fee | $35,240 | $38,020 | $29,370 | $31,920 | $31,920 |
| DMF Fee | $51,140 | $42,170 | $26,720 | $31,460 | $31,460 |
| API domestic | $44,234 | $40,867 | $41,926 | $34,515 | $34,515 |
| API foreign | $59,234 | $55,867 | $56,926 | $49,515 | $49,515 |
| FDF domestic | $258,646 | $243,905 | $247,717 | $220,152 | $220,152 |
| FDF foreign | $273,646 | $258,905 | $262,717 | $235,152 | $235,152 |
The FR Notice discusses the calculation of each fee based on FDA’s projected estimates of ANDA, PAS, and DMF submissions, as well as return of fees for refuse-to-receive issues, inflation calculations, Full Application Equivalents (FAEs), which represent a blend of ANDA and PAS application fees factoring inthat the PAS is only ½ of a full ANDA fee. The original total base fees for GDUFA were $299 million. As expected, the cost factors and reporting of actual costs with inflation appear to be significantly higher than the base. FDA calculations of the fee revenue for FY 2017 yielded an inflation adjusted target revenue of $323,011,000 (rounded to the nearest thousand dollars). So, as we come up on FY 2017 in about three months, start planning for your new fees and get those numbers crunched into your budget projections for the new fiscal year.
