FDA仿制药审评积压数据分析
出自识林
FDA仿制药审评积压数据分析
笔记 2016-05-14 Lachman CONSULTANTS 我一直在试图比较积压数字、新ANDA接收量和在企业手中的需要回应FDA完全回应函（CRL）的申请，这相当棘手。但我想我现在已经有所收获，我希望我是对的！过去用来计算GDUFA之前的“积压”的方式只是在仿制药办公室（OGD）未决的ANDA。现在的计算方式包括等待OGD审评的ANDA和在企业中待回复的或已经暂时批准的ANDA，意味着OGD将需要再次接触这些ANDA。这种二分法似乎是我面临的困境的核心所在。 在精确定位真正的积压是什么（除了它的定义）过程中的另一难题是在不断变化，因此无法确定绝对积压总量，因为申请每天都会从一个类别变到另一个类别。所以当讨论“积压”时，需要确定所谓的积压是什么。例如，下图是来自2016年5月仿制药审评指示板 该图表聚焦GDUFA第三年前的ANDA队列（我假设也包括2012财年之前的积压ANDA）。如果这个假设是不正确的，那么我们会有更大的问题。但，如果假设正确，那么我们处在比我们所有可能的考虑都更好的状态。 下面是仿制药审评指示板对ANDA工作量的报告。 人们（包括我自己）已经报告了大约4000+的ANDA积压，但似乎并没有合理的表征与过去（GDUFA前）所报告的积压数据的比较。为什么这样说呢？如上所述，过去的积压数据在历史上仅包括在FDA待决的ANDA（新接收的ANDA和企业已回复FDA信函的ANDA）。因此，GDUFA前积压的高度接近3300件ANDA积压。在上述图表中OGD报告他们的总工作量为4134件ANDA；然而这一数据包括目前在企业（而不是OGD）待决的ANDA和目前已获得暂时批准的ANDA（总共1332件）。因此，如果我们将旧的3300件GDUFA前的ANDA积压数据（仅在OGD未决的ANDA）与上面提到的4134件ANDA，并减去1332件（在企业待决的ANDA和获得暂时批准的ANDA），那么真正在FDA待决的积压数据是2802件，这实际上相当于2013年8月总共2780件FDA待决ANDA。考虑到自2012财年递交了大量的ANDA（从2012财年到2015财年平均每财年1018件），我们对OGD做得怎么样能够看得更清楚。 不幸地是，企业衡量OGD的成功主要是通过批准数量。也许我们需要将OGD已经取得的进展考虑在内，并开始相信这一进展将在2016财年剩下的时间和2017财年继续获得提高，并转化为较高的月平均批准。请记住，OGD本财年有望创纪录达到GDUFA后批准数量的新高。 另外，OGD刚刚更新了其2016财年仿制药计划行动报告，显示2016年四月，OGD发布192封完全回应函，成为自GDUFA计划启动以来发布CRL最高的月份。次高的月份是2016年3月，发布147封CRL，在此之前为2015年7月的134封CRL。 Lachman CONSULTANTS - Bob Pollock先生 Let's Not Mix Apples with Oranges I have been attempting to compare backlog numbers, receipts of new ANDAs and applications that are in the hands of industry for response to FDA’s Complete Response Letters (CRLs), and it has been quite a struggle. But I think I’ve got it now, and I hope I am right! The way the “backlog” used to be counted pre-GDUFA was simply ANDAs that were pending at OGD. The way it appears to be counted now includes ANDAs pending OGD review and those that are with industry or are already Tentatively Approved, which means OGD will need to touch them again. This dichotomy seems to be at the heart of my dilemma. One of the other problems in pinpointing what the real backlog is (besides its definition) is that the needle is continuously moving, so one is never sure of the absolute backlog totals, as applications slip from one category to another every day. So when talking of the “backlog”, one needs to be certain of what they call the backlog. For instance, below is a chart from the Generic Drug Review Dash Board which can be found here It focuses on GDUFA pre-year 3 ANDA cohorts (which I am assuming also includes the pre-FY 2012 backlog ANDAs). If this assumption is not correct, then we have a bigger problem. But, if it is correct, then we are in better shape than we may have all considered. Here is the Generic Drug Review Dashboard report for total ANDA workload activity as reported in the above referenced document. People (including me) have been reporting a backlog of some 4000+ ANDAs, but that does not seem to be a fair characterization of a comparison to past (pre-GDUFA) reported backlog figures. Why do I say this? As noted above, previous backlog figures have historically counted only those ANDAs that were pending at the Agency (newly received ANDAs and ANDAs for which the industry had responded to an Agency letter). So, in the height of the backlog pre-GDUFA, there were close to 3300 ANDAs in the backlog. OGD reports their total workload in the chart above as 4134 ANDAs; however, that figure includes ANDAs currently pending with industry (not OGD) and those ANDAs that currently have Tentative Approval (which together total 1332). Thus, if we compare the old cited backlog figure of 3300 ANDAs pre-GDUFA (ANDAs pending only at OGD) with the 4134 cited above and subtract 1332 (the ANDAs pending industry and those that are tentatively approved), then the backlog figure those that are pending with FDA is really 2802-which is actually comparable to the total FDA pending ANDA back in August of 2013 of 2780. Considering the large number of ANDAs that have been submitted since FY 2012 (averaging 1018 per year from FY 2012 thru FY 2015), we have a better view of how well OGD is really doing. Unfortunately, industry measures OGD success primarily by the number of approvals. Maybe we need to factor into the equation the progress that OGD has made and begin to believe that that progress will continue to improve over the rest of FYs 2016 and 2017 and translate to a greater monthly average of approvals. Remember, OGD is on track to hit a record number of approvals post-GDUFA this FY. And also remember that making a comparison of apples to oranges sometimes happens to the best of us! By the way, OGD just updated its Activities Report of Generic Drug Program FY 2016 showing that in April 2016, OGD issued 192 CRLs, the highest monthly number of CRLs since the inception of the GDUFA program. The second highest month was March 2016, where OGD issued 147 CRLs, and before that, it was 134 CRLs in July of 2015. |
的图表。
