首页 > 资讯 > ANDA目标行动日期 – FDA能否满足企业期望？

出自识林

2016-03-04 Lachman CONSULTANTS

目标行动日期（TAD）是GDUFA的附加产品，是仿制药办公室（OGD）提出并制定以增加审评过程透明度，帮助企业预测何时能得知OGD对GDUFA第三年前的ANDA提交采取行动。如仿制药办公室主任“Cook”Uhl博士所说，TAD本质上只是期望。随着TAD项目及其任务的启动，企业已经明白这一事实。需要明确的是，企业感谢TAD项目，并理解GDUFA既定目标日期和期望TAD之间的差异。但在大多数情况下，人类有任何情况下寻找积极面的本性，因此在TAD的情况中，企业必须接受他们的期望和OGD满足期望日期的能力之间可能有差距。

我们从企业中听到，许多TAD已经满足，如果没有满足，收到回复之日稍有延迟。然而，我们现在正看到更多证据显示TAD可能会逐渐失效。我们最近听到几个关于错过TAD而对申请没有行动的例子。事实上，OGD引入了一些范例语言在当TAD可能被错过时提供给企业，这些范例语言如下：

“这封信是关于通知详情如下XXX的目标行动日期。看来我们可能无法对该申请执行如下目标行动日期，对于我们可能无法对该申请在此日期前提供行动函，我们表示遗憾。由于我们对2012仿制药使用者付费修正案（GDUFA）的实施，出于好意提供目标行动日期以帮助申请人确定何时会对他们的申请采取行动。如您所知，目标行动日期不是GDUFA目标日期，而是由FDA努力对ANDA采取行动的内部管理目标。我们将继续推动该申请尽快进入监管审评流程。我们将不会设定新的目标行动日期，但如果您之后还没有接到来自FDA的沟通，您可以在早期（未来3-4个月）联系项目经理获得更新。”

虽然这对于期待申请得以采取行动的企业来说可能是个坏消息，好消息是OGD正继续将重要状态信息与企业沟通，因此，也许会避免任何意外情况。在我看来，这表明OGD正做出额外努力以保持申办人消息通畅。

正如之前的资讯【FDA 2016财年2月ANDA批准数据】中提到，OGD的资源正被分配到确保符合GDUFA强制目标日期的地方，并且基于不断变化的工作量考虑，已分配TAD的积压ANDA和GDUFA第1年和第2年申请的审评可能受到影响以确保GDUFA目标日期得到满足。资源的重新分配与我们所看到的例子是否相关尚不完全清楚，或者是否有其它考虑可能导致TAD被错过，但GDUFA下提交的ANDA越多，审评过程压力越大，并且这一压力将迫使OGD将其力量集中在确保符合GDUFA目标上。

希望随着GDUFA机器的运转，如果每月速度都更快一点，那么被分配TAD的申请可能更容易满足预期估计。

Lachman CONSULTANTS - Bob Pollock先生
编译：识林-椒
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TADs – Can OGD Meet the Aspirations of Industry? By Bob Pollock | March 3, 2016

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.