All User Fees programs are required to report on accomplishments against goals set for the particular User Fee program each fiscal year (that is October 1 to September 30). Fiscal Year 2013 is the first full year of GDUFA and FDA has presented its first Performance Report to the President and Congress. Admittedly since review time metrics don’t begin until the 3rd year of the 5 year GDUFA authorization, it lacks a little meat; however there are a few interesting pieces of information.
Historically OGD has not been very forthcoming with review performance metrics when things were not improving, but User Fees will from FY 2015 make sure these are reported to Congress (and the public since these reports are public). This report begins with an introduction that states that in calendar 2012 84% of “outpatient prescriptions” were filled with generics. Then follows an explanation of what a generic drug is followed by a table of the 5 year preview performance metrics.
Perhaps the most significant FY 2013 performance metrics is that OGD should hire at least 25% over the overall GDUFA program staffing. The report states that as of September 30, 2013 they had hired 291 or 31% of the planned GDUFA staffing. This tells us for the first time that GDUFA plans to hire about 940 new staff in total. They also instituted the “self-identification” system for facility identification to enable facility fees to be assessed and paid.
Then follows a few pages on IT systems and technology which was identifies as a weakness to be fixed by GDUFA.
Then we get to the most interesting parts, Generic Drug Review Performance and Risk-Adjusted Biennial cGMP Surveillance Industry. The Review Performance section contains a table which describes key metrics (Table shown on next page). This table tells us that 992 new ANDAs were submitted in FY 2013 and 71 (7.2%) were refused. It is interesting to note that there were 953 Controlled Correspondences in the same period of which 26 (2.7%) required input from the clinical division. This indicates that there are still a very large number of issues that are not clear from current guidance. What is surprising is that only 12 Complete Response Letters were issues (presumably for the ANDAs filed in this FY 2013 cohort). Finally there were as of September 30, 2013 2,867 original ANDAs pending and 1883 Prior Approval Supplements pending.
Apparently no original ANDAs submitted in 2013 were approved and 53 PAS of the 265 submitted in FY 2013 were approved.
Of the ANDA and PAS backlog (pending on October 1, 2012) 30% of the ANDAs and 40% of the PASs received a first action. Over 1200 Complete Response letters were issued.
Total Controlled Correspondence requiring input from clinical division
26
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-
-
-
ANDA Review Efficiency
Number of CR Letter with inspection recommendations
7
-
-
-
-
Number of CR Letter without inspection recommendations
5
-
-
-
-
Number of PAS CR Letters
19
-
-
-
-
Backlog Applications
Original ANDAs
2,867
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-
-
-
PASs
1,883
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-
-
-
On cGMP Inspections, the following table summarizes the FY 2013 performance. The report states that FDA is still gearing up to increase inspectional frequency.
Frequency of cGMP Surveillance Inspections: FDF and API Sites
cGMPSurveillance Inspection Type*
Location
FY 13
FY 14
FY 15
FY 16
FY 17
FDF Facilities
Domestic Facilities Inspected
82%（2-yr cycle）
-
-
-
-
Foreign Facilities Inspected
65%（2-yr cycle）
-
-
-
-
API Facilities
Domestic Facilities Inspected
80%（3-yr cycle）
-
-
-
-
Foreign Facilities Inspected
67%（3-yr cycle）
-
-
-
-
* A facility indentified as producing both a generic FDF and generic API was counted as FDF.
On cGMP Inspections, the following table summarizes the FY 2013 performance. The report states that FDA is still gearing up to increase inspectional frequency.
There is a section addressing “Quality and Transparency Initiatives”, an area where Industry is very unhappy with the steps taken to date.
Finally the Report addresses FY 2013 Research priorities which were included in the initial GDUFA agreement letter and the FY 2014 research priorities. This is an area that I find somewhat mystifying. The original priority number 11 has become priority number 1. The mechanism of this “transformation” is unclear to me. Also the FY 2014 list of research priorities is small compared to the original list.
There is an interesting appendix that explains many of the terms used in some depth. This list should be studied to shed light on what OGD is thinking when they use many of these terms.
