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2014-07-30 Lachman CONSULTANTS

虽然仿制药办公室的总行动数据（包括完全回应函CRL的发布等）将在本月结束后的2周后才会被发布，令人失望的是到现在为止本月显示的批准数量仅有十几件。

尽管OGD有许多事情在做（培训新员工、制定指南和政策、重组超级办公室，以及其它重要事项），而对于企业的底线是OGD发布的批准数量，以及OGD对所接受申请缺陷回应的数量和时效性。但是，从对企业重要性的角度讲批准决定了一切，毕竟，收到CRL是不能销售产品的。

我离开OGD已经20年了，当我在那儿时，我们使用“货运”术语来形容对申请者行动的重要性。当数量低时，我们催促审评员加快申请。我们跟踪那些接近批准的申请，以保证重要的问题能够迅速得到解决从而发布批准。我们如鹰隼一般观察审评队列，如果一件ANDA接近180天的审评时间，我们去敲审评员的门以确保他们知道最后期限即将到来。我必须承认那时我们的工作量更可控，但我们的人手也远少于现在。当我在1994年末离开OGD时，我们有155名工作人员处理工作。在GDUFA之前，OGD有350名工作人员，现在随着GUDFA雇佣，很快将接近600多名人员。我也承认审评越来越复杂和细致，对申请人的要求也一直在增加，但我不确定额外的那些要求对于审评过程都是有价值的。例如，实施质量总览概述（ANDA中45-60页的摘要）的目标之一是向审评员提供一份书面叙述，其目的是通过向审评员提供一份路线图以加快对ANDA的决定。这份路线图包括申请中包含什么，并进一步解释了他们的生产的产品是什么，如何生产以及为什么这样生产，这些在ANDA剩余部分均有数据支持。但是，这对企业来说只是成为另外一项费时费力的工作，在对ANDA审评行动的时间总量方面没有明显差别。现在OGD要求三倍的稳定性数据，要求企业验证USP方法（我希望这只是一个一次性的错误，但最近我们在LCS看到一些事情），并把其它额外的要求加诸于申请人。所以，经营成本在上升，不仅需要生成额外的数据，还需要花费时间获得批准。

我希望我更好地理解OGD新的“幕后”操作系统，更好地理解药品质量办公室和OGD两个超级办公室之间的相互作用，更好地理解为什么货物不是沿着最快的轨道搬运，更好地理解新的透明度如何才确实是透明度。但我已经离开FDA很长时间了，或许斜坡上升比我能预想的困难很多。但我的猜测是，仿制药企业将仅通过3件事情来度量OGD的成功：1）其所接收到的待决申请状态信息的质量和数量；2）其所接收CRL的数量和速度；以及3）其所接收批准的数量和速度（众所周知这并不是GUDFA目标函中的目标之一）。其它的一切对于仿制药企业来说都是噪声而已。

GDUFA的第3年即将来临，OGD的新秩序肯定会受到更严厉的审视，新法带来的蜜月开始消退。行业作为一个整体将会考虑“货物在哪儿？”，关于这一问题他们的声音会变得更加响亮，这只是时间问题。

Lachman CONSULTANTS - Bob Pollock先生 2014-07-30
校译：识林-椒 2014-07-30

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With Two Business Days Remaining in July, OGD has Only Approved 17 ANDAs
Written by Bob Pollock • July 30, 2014

Although Office of Generic Drugs (OGD) total activity numbers (including issuance of Complete Response Letters (CRLs), etc.) will not be posted until about 2 weeks after the close of the month, it is disappointing that the number of approvals this late in the month appears only in the teens.

While there are many things going on at OGD (training of new staff, Guidance and Policy development, the reorganization to a Super Office, among other important things) the bottom line for industry is the number of approvals that OGD issues and the number and timeliness of OGD deficiency responses it receives. But approvals rule the roost in terms of industry importance because, after all, you cannot sell products that receive CRLs.

It has been 20 years since I left OGD but, when I was there, we used the term “moving the freight” to describe the importance of getting actions to sponsors. When numbers were low, we pushed the reviewers. We tracked applications that were getting close to approval to assure that important issues were addressed quickly so the approval could be issuee. We watched the review queue like a hawk and, if an ANDA was getting close to the statutory 180 day review clock, we showed up at the reviewer’s door to assure they knew the deadline was coming. I must admit we did have a more manageable workload at the time, but we had far fewer people as well. When I left OGD at the very end of 1994, we had 155 staff handling the workload. Prior to GDUFA, OGD has about 350 and, now with GDUFA hires, that will soon be in the neighborhood of 600+. I will also concede that the reviews have become much more complex and detailed and that requirements for applicants are increasing all of the time, but I am not always certain that the additional requirements bring value to the process. For instance, one of the goals of implementing the Quality Overall Summary (the 45-60 page summary of the ANDA) was to provide reviewers with a written narrative that was supposed to speed the decision on the ANDA by providing the reviewer with a road map as to what was contained in the application and further explain up from the what, how and why they made their product which was to be supported by the data in the rest of the ANDA. But this just became another time-consuming effort for industry with little apparent difference in the amount of time actions took on ANDAs. Now OGD is requiring three times as much stability data, asking firms to validate USP methods (I hope this was a one-time mistake but something we have recently seen at LCS) and placing other additional requirements on sponsors. So the cost of doing business continues to rise, not only from the need to generate additional data, but the time it takes to get an application approved.

I wish I better understood the new “behind-the-scenes” OGD operating system, better understood the interplay between the Office of Pharmaceutical Quality and OGD now that the two are separate Super Offices, better understood why the freight is not moving down the tracks at a faster pace, better understood how the new transparency is really transparency. But I have been gone from the FDA for a long time and perhaps the ramp up is much more difficult that even I can imagine. But my guess is that the generic drug industry will measure OGD’s success by only three things: 1) the quality and quantity of information it receives on the status of its pending applications; 2) the number and speed of the CRLs it receives (that is one of the GDUFA goals) and; 3) the number and speed of the approvals it receives (which as we all know is not one of the goals found in the GDUFA goals letter). All else will likely be noise to the generic industry.

With year 3 of GDUFA around the corner, the new order in OGD will certainly come under even greater scrutiny, as the honeymoon afforded by this new law begins to fade. It is only a matter of time that the industry as whole will wonder “where’s the freight?” and their voices will become even louder on this issue.