PQRI Presentation Provides Interesting Insights

In a September 17, 2014 presentation at the FDA/PQRI Conference on Evolving Product Quality given by Susan Rosencrance, Ph.D., Acting Deputy Director, Generic Drug Chemistry in the Office of Pharmaceutical Science at CDER, a number of interesting issues were presented and discussed.  Some of these issues may be a welcome sign to the industry of a turnaround at OGD, but others still need some explaining.  For instance, we all know that the Office of Generic Drugs (OGD) has been receiving more ANDAs than the 700-750 anticipated during the GDUFA negotiations.

OGD has received over 1400 ANDAs in FY 2014 and this has placed a significant strain on OGD, as well as the Office of Compliance staffs.  OGD recognizes that, if they are going to get a handle on this workload, they need to move more towards a single cycle review to approval.  Multiple review cycles make for an extremely inefficient process, so OGD has decided to enhance their mid-review communications with industry, if such communication will possibly avoid another review cycle.  This “real time” communication will reduce the back-and-forth and may result in an application receiving approval if the applicant can clarify certain easily correctible deficiencies relayed by OGD reviewers.  This is much like the process in place for NDAs and will, hopefully, improve the efficiency of reviews and reduce the number of review cycles.

We can appreciate that the reported moving average of 4 review cycles to approval is something that industry and OGD needs to reduce.  Think of it this way – if an ANDA goes through on the first cycle in FY 2015, it could be approved in 15 months if OGD reaches its target goal date for that application.  If it has to go through 4 cycles, that time to reach approval could be approaching 3-4 years.

One encouraging area is in the supplemental application arena.  OGD has enlisted outside help (from New Drugs chemists, which OGD terms the “Supplement Review Squad” [which, by the way, also now resides in the Office of Product Quality]) to review the pre-October 1, 2012 (backlog) supplements and the Supplement Review Team (the “OGD Chemists”) concentrating on post-GDUFA supplements.  From the numbers presented by OGD, it appears that the total number of supplements pending before OGD has decreased from about 5500 to about 3000, a welcome sight for industry I am sure!

As far as the number of days for ANDA review (and I believe this is just Chemistry) take a look at the dramatic cut in days for the process from assignment to final sign-off.  If this trend keeps up then we are certain to see some real improvement in the review times for ANDAs if the other disciplines follow suit.

Unfortunately, one thing that belies these numbers is the length of time from submission to when the assignment to a reviewer is made.  We expect that that number is a key to the longer than expected time to the issuance of a complete response letter. With dramatic reductions like this one would expect to see either the number of approvals increasing or the number of complete response letters increasing.  So far, this review time reduction has not translated into a significant increase in actions.  But we can all hope!  Stay tuned for the October 1, 2014 start of GDUFA metrics and keeps your eye glued to this blog for tracking the progress of OGD in its efforts to meet the GDUFA goals.