OGD Performance – Fiscal Year 2014
Written by Garth Boehm • October 11, 2014
OGD's fiscal year ended on September 30 and the final ANDA performance numbers are now out. It is not good news for FDA or for industry. Total GDUFA receipts are now over $600 million and industry's return on that investment is not looking good.
What industry cares about, and what drove the establishment of GDUFA, is ANDA approvals. In that regard things continue to get worse as the table below shows.
FY 2013
FY 2014
Increase/Decrease
Pending ANDAs (start of FY)
2868
3044
+176
Approvals
440
409
-31
Tentative Approval
95
91
-4
Refuse-to-Receive
150
173
+23
Withdrawn
107
179
+72
Total ANDAs Dealt With
792
852
+60
Pending ANDAs (end of FY)
3044
3665
+621
ANDA Approvals and Tentative Approvals both declined going from GDUFA Year 1 to GDUFA Year 2. So the main, many in industry would say only, meaningful GDUFA statistic is going in the wrong direction.
Although the total number of ANDAs dealt with (meaning the FINAL DISPOSITION of an ANDA) increased by 60, 72 of that 60 increase comes from withdrawals! Even tightening the Refuse-to-Receive conditions only added 23 additional refusals for the year.
The most concerning figure is the Backlog which stands at 3665 at the end of GDUFA Year 2. The new FY, 2015 is the first year in which performance goals apply, although only to ANDAs filed from October 1, 2014 onwards. FY 2014 saw the largest number of new ANDAs filed ever, 1473. This should be no surprise to anyone, the imposition of the “3 batch, 6 months accelerated stability” requirement in mid-June obviously led to an avalanche of ANDA filings to beat this deadline, indeed only a total of 33 ANDAs were filed in the following 3 months. I do not expect filings to return to normal levels until December 2014.
At the start of FY 2014 FDA reported a median ANDA approval time of 36 months. This median approval time looks as though it will continue to increase. Many of the ANDAs in the backlog have been pending for well over 36 months and continue to age “in situ”. I predict that median approval time is currently approximately 40 months and will increase beyond that if drastic action is not taken to change the current glacial pace of ANDA review. 2441 new ANDAs were filed in FY 2013 and FY 2014 combined meaning that 1224 ANDAs that paid the “backlog fee” remain in the queue from before GDUFA.
OGD says that they have met all their GDUFA goals, including those related to hiring and training new review staff. The problem here is CMC review. It is rather ominous to me that CDER's “Key Officials” list dated October 7, 2014 contains no reference to any generic Drug CMC review group (and no reference to the new Office of Product Quality review function). The other observation is that the list is 36 pages long!
So we are only 6 months from the midpoint of the first 5 year GDUFA, there is obviously a long way to go before industry will be happy with its GDUFA investment.
没有提及任何仿制药CMC审评工作组（也没有提及新的药品质量办公室的审评功能）。另一方面的观察是，名单有36页长！