The FDA announced today that the total collectable amount of fees under the GDUFA program (adjusted for inflation and salary increases) will be $312,224,000, up from the original $299 million that was authorized for year 1 of GDUFA. The good news/bad news is that ANDA and PAS fees decreased. Why is this bad news? Because it means the numbers of ANDAs submitted increased significantly enough to not only off set inflationary trends, but to decrease the amount charged for each application by about $5,000 (and this clearly has not taken into account the large numbers of ANDA submitted in June of this year). The bad news for the Office of Generic Drugs is that they have many more ANDAs to review. The other bad news is that the active pharmaceutical ingredient (API) and Finished Dosage Form (FDF) facility fees jumped again (but not as steeply as last year), as fewer facilities self-identified or have been taken off line (no longer named) for use in generic applications.
Here are the new fees for FY 2015 compared to the previous two years.
FY 2015 FY 2014 FY 2013
ANDA Fee $58,730 $63,860 $51,520
PAS Fee $29,370 $31,920 $25,769
DMF fee $26,720 $31,460 $21,340
API Domestic $41,926 $34,515 $26,458
API Foreign $56,926 $49,515 $41,458
FDF Domestic $247,717 $220,152 $175,389
FDF Foreign $262,717 $235,152 $190,389
For many generic firms or contract manufacturing organizations (CMOs), the most troubling fees are the facility API and FDF fees, as these are paid annually. Not much of a problem for a large generic firm with many approved applications, but a big burden to a new firm with only pending applications and no revenue, or a CMO that only has one or two generic clients. Remember, a generic ANDA is taking about 30-34+ months to approval. That means three years of facility fees may be due prior to the first revenue for some firms.