While we reported that July had already broken the previous approval record prior to the official July numbers being posted in an earlier post (here) we were happily shocked when the official approval numbers came out today (here). OGD fully approved a record 96 ANDAs (previous record was 88 in June FY 2017) and tentatively approved 30 ANDAs (previous record was 23 in November 2017 (also in FY 2018) for a total 126 approval actions!
We previously noted that OGD still had a chance to beat the FY record of approvals of 763 set in FY 2017. With just two months to go, a straight-line estimate places them at 799 approvals for the year. That is certainly a target to shoot for.
This is truly a record-shattering month for the Generic Program under the GDUFA banner. OGD also crushed the previous record of 325 complete response letters (CRL) in October 2017 by issuing 357 CRLs in July.
OGD reported receiving 90 ANDAs, putting the straight-line estimate for FY 2018 at 1016 ANDAs expected to be received this FY. This would be the third highest FY for receipts since the start of GDUFA.
In addition, OGD also updated its June FY 2018 statistics today. There were eleven refuse-to-receive (RTR) actions reported for June and of those, four were for standard ANDAs and seven were for priority GDUFA II applications. Looks like it may be the rush to get the priority review ANDAs into the Agency that could be causing a problem with the high rate of RTR actions for priority applications. Just saying!
Many of the other action items like, information requests or DMF reviews, look consistent to other months but there was a surge in the number of discipline review letters which hit a high for the FY at 322 (almost 100 more than any other month). ANDA amendment submissions were at 202, with 108 being classified as major, 92 as minor, and there were two unsolicited amendments received in June (looks like the industry has gotten the word on the negative review time line when submitting an unsolicited amendment to a pending application).
Changes-Being-Effective supplements had a FY high month at 675, while Prior Approval supplements were right at the monthly average of 82 for the FY. Controlled Correspondence (CC) was at a high for the FY at 266. Based on my personal experience, it could be the CC Catch-22 and recycle merry-go-round that I have experienced. I have also heard many other complaints by firms indicating that either FDA response is not adequate or does not really answer the question. Also, industry complains that reasons for denial of acceptance of the CC oft times seem to express a lack of understanding of some of the more intricate Hatch-Waxman regulations, and misapplication of guidance principles among, or misunderstanding of, the requested question. Perhaps it might be useful to be able to speak on the phone to the FDA responder for some of these denials rather than starting a new cycle of multiple submissions, which might be cleared up in a call making the process more efficient.
All in all, the review and approval of ANDAs appears to be moving along at a better clip than ever before and here’s hoping the Agency can sustain the effort.