The month of May 2017 may go down as the true turning point in the Office of Generic Drugs (OGD) review and approval process. If not, it will at least go down as the second highest number of approval actions in a single month since the start of the GDUFA program. OGD reported fully approving 77 ANDAs and tentatively approving 19 ANDAs for a total of 96 approval actions, just shy of a record. The highest month for such actions was December 2015, when a total of 99 approval actions (79 full approvals and 20 tentative approvals) was reported.
So why do I think this may really be the turning point? Because the number of Complete Response Letters (CRLs) issued in May was at a 19-month low of only 98. One might think that is bad news, but I am willing to take a more positive view and hoping that the OGD/Office of Product Quality (OPQ) information requests and easily correctible deficiency letters, as well as calls to applicants close to approval, may be driving more ANDAs towards approval rather than to a CRL. Only a few more months of high approval action will cement that hope, but let’s see how it goes.
The other good news for the month is that OGD received fewer ANDAs (66) than it approved. Based on the figures to date, if we straight line approval and receipt figures for FY 2017, we can expect OGD to have fully approved 715 ANDAs (which would be a new record) but also to have received 1330 ANDAs. Stated another way, OGD will have received 72% more receipts than it approved in FY 2017 (this leaves out tentative approval action and I do so for a reason). Clearly, for progress to be made, that percentage needs to get to less than zero.
Thus, while May may be a turning point, we believe that more turning needs to be made. We hope our enthusiasm for the May figures is not misplaced and that subsequent months show similar or even better results. GDUFA II is right around the corner and firms will be anxious to see more good news before the new fee structure goes into place.