With October 1, 2015 signaling the start of cohort year 4 of the GDUFA program, the receipt and approval numbers are in the book for first three years of the program.
Let’s take a look at the numbers to see where we may be heading.
FY 2015 showed just 17 more receipts than approvals. This means that the absolute backlog only could have grown by no more than 17 applications. With some withdrawals (and potentially abandonment) of some older applications, perhaps we may be at a wash for the year. The most striking figure is that only 509 ANDAs were submitted in cohort year 3 (FY 2015). This figure is substantially lower than any year in modern-day history. Could this be because of the many mergers and acquisitions (M&A) that have taken place over the last few years? Is it because of the M&As that many firms had to divest certain of their applications, thus making it more attractive for another firm to purchase the approved asset rather than submit its own application for the product? Is it because of the patent cliff? Is it because of the increase in regulatory and stability requirements? There is likely not one single answer to this phenomena, but I am certain that this drop in original ANDA submissions is making the Office of Generic Drugs (OGD) breathe a little easier.
Lower submission rates make it easier to meet the GDUFA goals (which kicked in on October 1, 2015), and thus, it follows that excess resources will likely be available to review the ”backlog” and cohort year 1 and cohort year 2 applications that did not have GDUFA goals. There are hints of some metrics to be applied to Complete Response Letter (CRL) responses for pre-cohort year 3 ANDAs. Wouldn’t that be nice!
OGD continues to struggle with communications, but at a recent meeting, some of the attendees actually noted that even this aspect of interactions with OGD is noticeably improving. We have seen a significant number of Target Action Dates (TADs) being assigned and that is good news for industry folks that need to make reasonable business decisions. We have also heard that more information is flowing about the status of the ANDA reviews – also a good sign.
We have been predicting that OGD was about to turn the corner and now it looks like their head may be peeking around the edge of the building. Maybe we will even see more FDA faces at the GPhA Fall Technical Workshop, as this is a great way for industry to learn who some of the new 600 hires are! Good job, OGD-keep it up!