The month of April 2015 saw the largest number of ANDA approvals since the implementation of GDUFA, with 48 ANDA full approvals and 19 tentative approvals (TAs). That is 65 approval actions and represents a post-GDUFA record that we hope is reflective of the fact that the GDUFA machine has begun to turn faster and may no longer be just spinning its wheels. The GDUFA outlook will be clearer after the next few months if the number of approvals continues to rise, as that will mean the efficiency of the process is kicking in. We are 2.5+ years into GDUFA and, hopefully, the training efforts are winding down and the Office of Generic Drugs (OGD) and Office of Product Quality (OPQ) are beginning to see that the hard work of its experienced reviewers(who are the ones training the newbies) are beginning to pay off.
Evaluating the entire output of OGD and OPQ is not an easy task from the outside. Here we are at the beginning of May and the Activities Report of the Generic Drug Program has just been updated for March. While approvals data is more evident and easy to find, we are still questioning what numbers to report, as there appears to continue to be a lag for listing in the various approval reports. For instance, the actual number of approvals for the month is 48 (verified by OGD), but the FDA Approvals by Month Report shows 42. In addition, while the number of Tentative Approvals was confirmed by OGD as 19, the same report shows only 4 TAs. We know that OGD is looking to try to rectify and reconcile the reporting of approval actions in the various public reports on the FDA website (What’s New at FDA, FDA Monthly Approvals Report, and the Activities Report of the Generic Drug Program). One would think that an approval action would trigger next day appearance on the reports, but so far that is not the case, as there are delays in updates to the various report formats making reconciliation of the numbers quite a task for those of us in industry. We do know that the FDA is working on this problem.
While we try to provide the most accurate data available, our posts are only as reliable as the data available at the time of the post. Therefore, we apologize to OGD if the numbers we report are not quite consistent with their tally at the time of publication of the post, but with interest in these numbers so intense by the industry, our reports demand timeliness.