In what has been a rather strange pattern of ANDA approval actions in May, the OGD has issued 36 full-approval actions and 5 tentative-approval actions in the first fifteen days of the month, which is a good result. However, the daily approval pattern seems a bit strange.
On May 2nd, the OGD issued 9 full-approval actions, and on the 14th, it issued 10 full-approval actions, which accounts for greater than 50% of the month’s approvals in just two days. There were four days with no full-approval actions posted and 2 or 3 approvals on the rest of the days. There was one day, May 14th, when 8 different ANDAs were approved for Rivaroxaban, but on the 2nd, the 9 ANDAs approved were mostly for different drug products. You’d expect a big day for approvals on the NCE-1 date, when a number of approvals would occur on the same day for a high-market value product. One explanation for the two big days followed by days when fewer or no approvals occurred could be staff shortages impacted by the RIFs, with new approvals being bunched together more than usual. The final approval process is a heavy administrative lift and, thus, this pattern may be reflective of clustering approvals to improve the efficiency and administrative focus required when a group of applications are nearing the final administrative review. Clearly, this month has displayed a pattern we have never seen over the last years in the GDUFA program.
This is obviously speculative because we haven’t seen the OGD’s official approval results for well over three months. We’ll continue to try to make sense of the impact of the OGD and OPQ staffing cuts and retirements on the flow of approvals and other FDA metrics as additional information becomes available.
