FDA Announces GDUFA Fees for Fiscal Year 2015 (October 1, 2014 to September 30, 2015)
Written by Garth Boehm • July 31, 2014
A Federal Register notice will publish tomorrow detailing the calculation of GDUFA fees for FY 2015. As you may recall, the overall total fee is adjusted each year for increases (or decreases) in the complex cost formula. The detail of this calculation is in the FR Notice. As required by the law, the increase in total fees is computed based off the original total of $299 million. The overall increase (that is from the $299 million base) is “4.4228% (rounded)” for a FY 2015 total of $312,224,000.
The rest of the Notice is devoted to explaining how FDA calculates the filing and facility fees. The table shows the GDUFA fee history.
Fee Type
% of Total with Backlog
2013FY
% of Total without Backlog
2013FY without Backlog
2014FY
% Increase FY14/13 Corrected
2015FY
%Increase FY15/FY14
TOTAL
$299m
$305.7m
2.25%
$312.2m
4.42%**
ANDA Backlog
20%
$17,434
0%
ANDA Filing
20%
$51,520
24%
$61,824
$63,860
3.3%
$58,730
-8.0%
PAS Filing
$25,760
$30,912
$31,930
$29,370
DMF Filing
5%
$21,340
6%
$25,608
$31,460
22.9%
$26,720
-15.1%
FDF Faciligy (Domestic)
47%
$175,389
56%
$210,467
$220,152
4.6%
$247,717
12.5%
FDF Facility (Foreign)
$190,389
$225,467
$235,152
$262,717
API Facility (Domestic)
12%
$26,458
14%
$31,750
$34,515
8.7%
$41,926
21.5%
API Facility (Foreign)
$41,458
$46,750
$49,515
$56,926
Note that the total increase is FY2015 relative to FY 2013 as required by the law, the other years are FY15/FY14 comparisons.
The first obvious thing to note is that the ANDA and DMF filing fees have decreased. This is because FDA has underestimated the number of filings they expect as this is based on looking back at past history in a system where filings are increasing and not steady. Note that the computation of ANDAs expected did not include the record June 2014 month, which makes sense because that number was driven by the changes in batch numbers and stability required to file ANDAs after June 19, 2014.
Conversely the facility fees have increased substantially. This is probably driven by sponsors “cleaning up” their facility references in existing ANDAs. A facility that might be references as a “just in case” alternate is likely to be withdrawn in the light of the fees. This is most marked for API facilities. Note that this will have the effect (intended or otherwise) of not referencing any “backup” facilities in the event that the primary facility cannot be used for any reason. This might eventually create a larger drug shortage risk profile. Note that FDA is also sticking with the $15,000 minimum additional charge for foreign facilities. They must have quite a travel piggy bank saved up by now!!
So there are big changes in individual fees, but overall the total continues to rise inexorably.
GDUFA User Fee Rates Announced for FY 2015
Written by Bob Pollock • July 31, 2014
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.
FY2015
FY2014
FY2013
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.
