With the first (albeit unofficial) count of ANDA approval actions since the layoffs at the OGD, the future does not appear bleak. At least not yet!
The postings through April 16th for approval actions show that the OGD has issued 43 full-approval actions and five tentative-approval actions for a mid-month total of 48 approval actions, which is a very hardy showing for mid-month.
The big question is whether the OGD will be able to continue at that pace when the dust settles. It’s quite possible that there were a number of ANDAs that were in the queue for final approval prior to the April Fool’s Day layoffs as a bolus of ANDAs received approval actions on April 15th and 16th. On those days, the OGD issued eight and seven ANDA approval actions, respectively. These two big days represent about one-third of the full approvals tallied in the first half of April. This comes just about one week after the Generic Drug Forum, which went off without a hitch and to me signaled some return to normalcy. However, as Marvin Gaye says, I heard through the grapevine of other OGD and OPQ staff who are also putting in their retirement papers so we’ll see what the rest of the month brings.
It isn’t known how the staffing reductions, reorganizations, and retirements will play out in terms of the near future, nor how it will impact the FDA’s output, but, at least for April, things look good.
