首页 > 资讯 > FDA仿制药工作报告出了什么问题？

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2015-01-21 Lachman CONSULTANTS

现在我们处于一月中旬，GDUFA指标第1年（GDUFA计划第3年）已经过去1/3的时间。我们之前曾经提到过，CDER的新IT平台出现问题，因此向企业报告其统计数据变得非常困难，而且使FDA之外的人非常困惑。例如，今天是1月20日，FDA月度批准报告（此处）显示到现在为止1月份共批准11件ANDA。其中前面9件批准都是缬沙坦片剂（缬沙坦日）（所有这些产品之前都收到暂时批准，后转向最终批准，所有批准都发生在2015年1月5日），另外两个产品分别于1月7日和8日获批，但在这之后网站上就没有更多的内容了。然而，今天在“What's New at FDA”上，FDA报告了首次获批仿制药利托那韦片剂，于2015年1月15日获批。因此，我们知道至少这两个数据库是不统一的，或至少未同步到一起报告。此前，ANDA批准情况会在批准之后在FDA月度批准报告中显示，并且通常会在CDER网页的“What's New”板块通告。我们发现这些现在都不会再发生了。也就是说，在公开网站上准确地追踪报告的批准量数字会非常困难（如果不是不可能的话）。

此外，2015年1月和2014年12月的统计报告（虽然很简略 — 同样是因为IT平台问题）超过一半的数字还没有更新。2015财年仿制药计划行动报告（请见此处）报告了有限的一些行动，包括月度批准和暂时批准、撤销、完全回应函、DMF审评，以及原始ANDA接收。许多在之前的报告中提供的其它统计数据还没有更新（在2015年的报告中是空白）。希望FDA能请其IT人员勤奋工作，统一不同的数据库，以产生企业需要的透明化的必要报告。

这是另一种定义时间的工作重点—时间是保持在一件件事情变得糟糕之前立刻修补！让我们希望，为了提高透明度和企业，FDA能迅速解决这个问题。

Lachman CONSULTANTS - Bob Pollock先生 2015-01-20
编译：识林-椒 2015-01-21
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So What's Wrong with OGD Workload Reporting?
Written by Bob Pollock • January 20, 2015

Lots! Here we are in mid-January, almost one-third of the way through the first GDUFA metric year and year three into the GDUFA program itself. As we have reported previously (here and here), CDER is having trouble with its new IT platform and, thus, reporting its statistics to the industry has been difficult at best and, at most, very confusing for anyone outside of FDA. For instance, here we are on January 20 and the FDA Monthly Approvals report (here) shows 11 ANDA approvals thus far. The first 9 approvals were for Valsartan Tablets (valsartan day) (all of the products moved to final approval after previously receiving tentative approval all of which occurred on January 5, 2015) and two additional products were also approved, one January 7 and the other on the 8th, but nothing more reported beyond that date on that site. However, today on “What's New At FDA”, the Agency reported generic first-time approvals and listed Ritonavir Tablets, which was approved on January 15, 2015. So, we know that at least these two databases are not coordinated or at least are not synced to report together. Previously, ANDA approvals showed up on the FDA Monthly Approvals Report the day after approval and were usually reported on What’s New on the CDER web page. We find that neither of those things are happening now. With that said, it is difficult (if not impossible) to track the approval traffic with a sense of accuracy relative to the numbers being reported on the sites available to the public.

In addition, it is more than halfway through January 2015 and the December 2014 statistical report (albeit abbreviated – again, because of the IT platform problems) has not yet been updated. The Activities Report of the Generic Drug Program for FY 2015 (here) reports a limited number of activities, including approvals and tentative approvals, withdrawals, Complete Response Letters, DMF reviews, and original ANDA receipts for the month. Many of the other statistics available in previous reports have not been updated (blank items in the 2015 report). Hopefully, FDA has their IT staff working diligently on getting the different databases to communicate and to be able to generate the reports necessary for the transparency the industry needs.

This is just another of the priorities that defines time – Time is what keeps one darn thing after another from becoming every damn thing at once! Let's hope for the sake of transparency and for the industry this issue is one that the Agency can resolve quickly.