Target Action Dates (TADs) are one of the GDUFA extras that the Office of Generic Drugs (OGD) has proposed and instituted to increase transparency in the review process and to help industry predict when it may hear from OGD about its pre-year three ANDA submissions. The TADs, as described by Dr. “Cook” Uhl, OGD’s Director, are only aspirational in nature. This fact has been clear to the industry since the inception of the TAD program and their assignments. To be clear, industry is thankful for the TAD program and does understand the difference between GDUFA fixed goal dates and the aspirational TAD. But, in most instances, human nature has a way of looking for the positive in any situation and, in the case of TADs, industry must accept that their aspirations and the ability of OGD to meet these aspirational dates may not always intersect.
We have heard from industry that many of the TADs have been meet or, if not, there has been slight delays in the date a response is received. However, we are now seeing more evidence that the TADs may appear to be slipping. We have recently heard of several examples where TADs are passing without action on the application (which is to be expected in some cases). As a matter of fact, OGD has introduced some boilerplate language to provide to firms when a TAD will likely be missed (see below).
“This correspondence is in reference to the Target Action Date notice as detailed below xxx. It appears that we may not make the Target Action Date identified below for this application, and we regret that we may be unable to provide an action letter for the application by this date. Target Action Dates were provided as a courtesy to help applicants ascertain when action may occur for their applications as we implement the Generic Drug User Fee Amendments of 2012 (GDUFA). As you may know, Target Action Dates are not GDUFA goal dates; they are internal, administrative targets by which FDA strives to take action on an ANDA. We will continue to move this application forward in the regulatory review process as quickly as possible. We will not set a new Target Action Date, but you may contact the Project manager in early (date about 3-4 months in the future) for an update if you have not received communication from the Agency by then.”
While this may be bad news to a firm expecting an action, the good news is that OGD is continuing to communicate important status information to the firm, and thus, perhaps avoiding any surprises. This demonstrates, in my opinion, that OGD is making an extra effort to keep the sponsor well informed.
As noted in my blog post yesterday (here), OGD resources are allocated to assure compliance with GDUFA-mandated goal dates, and that, based on changing workload considerations, the review of backlog ANDAs, and GDUFA year 1 and 2 applications that may have TADs assigned may suffer to assure that GDUFA goal dates are met. It is not entirely clear if the resource reallocation is associated with the examples we have seen, or if there are other considerations that may cause a TAD to be missed, but the more ANDAs that are submitted under GDUFA, the more pressure is placed on the review process and it is clear that that pressure will force OGD to target its effort to assure compliance with GDUFA goals.
Hopefully, as the GDUFA machine continues to move the freight, and if the freight moves a bit faster each month, then applications that are assigned TADs may be more likely to meet those aspirational projections.
