And the Walls Come Tumbling Down – Let’s See!

Today is June 11, 2015, and there are major milestones being hit.  First of all, today is my 44th wedding anniversary – that’s a big one! But also, by the end of the day, the Office of Generic Drugs (OGD) will have close to 30 approvals and 3 tentative approvals out the door.  That could mean possibly hitting record approvals numbers under GDUFA for the month of June.

In addition, I have been hearing from senior OGDers that they hear loud and clear that industry is looking for more transparency and communication and, while in industry’s view, it has been slow to come, the signal and message that OGD most wants industry to hear is “that the walls are about to come down.”  The next best thing besides increased communication in the review process that would clearly help demonstrate movement in a positive direction would be to have clear reporting on the monthly statistics and the actual ANDA backlog.  The Activities Report for the Generic Drug Program FY 2015 has not been updated since the March data was populated in at the very end of April.  The report may make more sense to the FDA than it does to industry because the definitions of the figures are not always clear.  For instance, the number of receipts of original ANDAs reported by OGD has been somewhat confusing.  OGD has been reporting receipts of original ANDAs and supplements for years by using the number of submissions that have come into OGD that month.  Now, under the new reporting requirements, the actual receipts are for those applications that have been both submitted and received (actually accepted for filing) in the month.  If an ANDA or supplement receives a refuse-to-receive (RTR) as the initial action, then it is counted in the month that it is finally acknowledged as received, which may include applications that were submitted in prior months.  This may mean that when the reporting requirements were changed, some applications may have been counted twice, as under the current requirements, the Agency must report responses to RTR letters separately, once the ANDA or PAS supplement is actually acceptable for receipt.   From the outside, it is hard to tell what the receipt numbers actually represent.

These are all growing pains of new systems and programs and will eventually be reconciled, so be wary of the receipt numbers until you are sure what they mean.  I will try to gain more clarity on those numbers but, right now, there may be a bit of a cloud over what they actually represent.

As has been customary, no matter what the FDA promises or says, the industry only believes it when they see it!  Let’s hope in the next month or two the evidence of improvement in communications both internally, among FDA review components, and externally, with industry, becomes evident.