FDA仿制药申请积压历史回顾
出自识林
FDA仿制药申请积压历史回顾
笔记 2015-07-17 Lachman CONSULTANTS 仿制药办公室（OGD）的积压问题已有多久的历史？ANDA的审评和批准过程的本质就保证了会一直有积压。因为企业在现有基础上递交申请，OGD花时间审评和评估每件申请。OGD成功的关键是保持积压在一个可控的水平。 1984年Hatch Waxman法案通过时，大批ANDA申请涌入。OGD（当时还是仿制药处）通过解决最初申请的高峰，然后才得以尽可能多的批准每月递交的ANDA。从历史上看，在任何时间摆在FDA面前的未决ANDA积压范围约为300到400件。从1990年到1997年，每财年OGD收到大约360件ANDA，能够批准300+件ANDA。 随着每月“不批准信”、批准和暂时批准，以及一些撤回，到2002年11月之前积压一直保持在400件ANDA的水平。2002年11月时趋势发生明显变化，积压开始增长。2006年底，仅仅4年之后，下面转载自OGD统计报告的表格中可以看出ANDA积压达到1300件。
2012年9月，积压增长至略低于3000件（OGD图表如下）。自那时起，OGD于2014财年收到1473件ANDA，是单一财年接收量最多的年度，而同一财年OGD仅批准了409件ANDA。1000+的净增长将积压推向了4000件。
2015年3月FDA给出的另一报告中，OGD提供了2002到2004财年ANDA递交与批准数量一瞥。不难看出为什么积压会如此显著地增加。每年的递交量以1.5倍到3倍的速度远超批准量。显然，这对于OGD来说是不祥之兆，但推动了2012年仿制药使用者付费法案（GDUFA）。
OGD如何清除积压、减少ANDA周期数并驱动申请批准，决定了GDUFA计划成功的关键。多重因素造成了今天的积压，我们过去曾经报道过一些。如果这些图表开始反映逆转趋势，不久OGD将宣布成功。 Lachman CONSULTANTS - Bob Pollock先生 2015-07-16 The Backlog at OGD – a Historical Look Yesterday, a reporter asked me how long has there been a backlog at the Office of Generic Drugs (OGD). I told the reporter that the nature of the ANDA review and approval process will guarantee that there is always a backlog. That is because firms submit applications on an ongoing basis, and it takes the OGD time to review and assess each application. The key to success is to maintain the backlog at a manageable level. When the Hatch Waxman Act passed in 1984, there was a huge influx of ANDAs. OGD (at that time the Division of Generic Drugs) worked its way through that initial rush of applications and then was able to approval about as many ANDAs as were coming in on a monthly basis. Historically, the backlog ranged from about 300 to 400 ANDAs pending before the Agency at any one time. From 1990 through 1997, OGD received about 360 ANDA per fiscal year (FY). OGD was able to approve about 300+ ANDAs per FY. With “not approval letters,” approvals,and tentative approvals, and some withdrawals each month, the backlog was maintained at a consistent level of about 400 ANDA until November 2002, when there was a decided change in the trend and the backlog began to grow. By the end of 2006, just four years later, the ANDA backlog stood at 1300 as depicted in the chart from the OGD statistical report reproduced below.
By September 2012, the backlog grew to just under 3000 (see OGD chart below). Since that time, OGD has experienced the largest number of receipts in a single FY ever when they received 1473 ANDAs in FY 2014; unfortuately OGD approved only 409 that same year. This 1000+ net excess in receipts vs. approvals in that year pushed the backlog up close to 4000 ANDAs.
In another FDA presentation given in March of 2015, OGD provided a look at the number of ANDA submissions vs. the number of ANDA approvals by FY from 2002 – 2014. It is not difficult to see why the backlog has increased so dramatically. The number of submissions outpaces the number of approvals by multiples ranging from about 1.5:1 to about 3:1 each year. Clearly, this is a bad sign for OGD and clearly was the impetus for the Generic Drug User Fee Act of 2012 (GDUFA).
How well OGD does with knocking down the backlog, reducing the number of ANDA cycles, and driving applications to approval will be the key to determining the success of the GDUFA program. There were multiple factors that resulted in today’s backlog, but we have outlined those in previous posts. Let’s just say that these charts need to begin to reflect a reversal in trend, and soon, for OGD to claim success. |
