The Office of Generic Drugs (OGD) just released its January productivity numbers and there are some interesting observations to share. First, the number of Refuse-To-Receive (RTR) actions hit 30, which ties the highest number of (October 2013) since the implementation of GDUFA. This is most interesting because OGD made mention of an anticipated increase in RTR actions at the GPhA Annual Meeting. This could also mean greater scrutiny for initial year three cohort applications, since OGD now has metrics associated with those applications.
Approvals for the month hit 25 which, so far, is the lowest number of approvals in FY 2015. If we straight-line that number for the first 4 months of the FY, one would expect OGD to approve about 381 ANDAs in FY 2015 (compared with 440 and 409 in FY 2013 and 2014, respectively). Looking at the receipts end of things, OGD received 27 ANDAs in January. Again, straight-lining the first 4 months numbers, OGD can be expected to receive about 438 ANDAs this FY (compared with 968 and 1254 in FY 2013 and 2014).
So, receipts are significantly down – at least so far- and approvals likely about 10% lower . However, the number of receipts still outpaces the number of approvals, which means OGD will still be playing catch up with the backlog which is likely still expanding (albeit at a slower rate).
Complete Response Letters (CRL) increased to 104 in January to yield a 4 month average of 79.5 CRL per month. The good news is that CRLs issued have increased each month so far in FY 2015. The big hit that OGD is taking appears to be in the amendments arena. These types of amendments obviously may impact the GDUFA review clock.
|Originals (Pre FY15) Administrative||119||228||388||339|
|Originals (Pre FY15) Solicited (CR, ECD/IR)||86||80||178||320|
|Originals (Pre FY15) Unsolicited||398||229||108||118|
|Originals (FY15) Administrative||1||21||20||30|
But, without knowing how many amendments are being submitted to each ANDA, not much can be inferred from this information, other than it represents a lot of work and tracking for OGD.
Changes Being Effected (CBE) supplements are being submitted at the rate of about 428 per month in FY 2015, while Prior Approval Supplements(PAS) are coming in at a rate of 37 per month in FY 2015. These numbers were not explicitly tracked in prior FY under GDUFA. And there are plenty of amendments coming into these supplements (see entire FY 2015 report here)
So now we are one-third through this current fiscal year and industry is still looking for progress on the productivity side. Some indications are positive but my guess is that industry is still waiting for a big breakthrough in the numbers.