I must honestly say that there is not a lot that stands out in this update for the December ”Activities Report of the Generic Drug Program Monthly Performance” that we have not either already commented on, or where there appears to be a significant trend, albeit there are a couple of issues that we point out for further scrutiny when more data for this FY is available.
On the refuse-to-receive (RTR) front, GDUFA I applications appear to continue to have a higher % of RTR actions. Does this mean that industry is submitting better applications under the GDUFA II requirements, or that OGD is providing more direction in IR letters during the initial receipt review that give applicants a chance to correct RTR issues? The other interesting RTR issue that I observed is that GDUFA II priority review applications appear to have a higher percentage of RTR action than standard GDUFA II ANDAs. Does this reflect a hurried approach to getting the priority review ANDAs into OGD by industry?
After two months of having a number of approved ANDAs voluntarily withdrawn (111 in the first two months of FY 2018), no approved ANDA were withdrawn in December and only 13 actions were processed to withdrawal unapproved ANDAs. For the withdrawal process to be official for approved ANDAs, there must be a Federal Register (FR) notice published announcing the withdrawals, and such notices take time to publish. This could be why there was a bolus seen in months 1 and 2 of FY 2018 and none this month. Unapproved ANDAs are simply withdrawn upon a firm’s written request and no FR notice is required or ever published.
All the other statistics seem to be in line with previous months. But, like I noted above, it will take a few more months before any real trends can be seen. The updated report can be found here.
