2014财年FDA仿制药办公室绩效
出自识林
2014财年FDA仿制药办公室绩效
笔记 2014-10-12 识林 仿制药办公室（OGD）本财年已于9月30日结束，最终ANDA绩效数字现在已经出来。无论对FDA还是企业都不是好消息。总的GDUFA账单现在已经超过6亿美元，企业的投资回报并不乐观。 企业关心并驱使制定GDUFA的是什么？是ANDA的批准。这方面的情况如下表所示继续恶化。
与GDUFA第1年相比，GDUFA第2年的ANDA批准和暂时批准均有下降。所以大多数主要企业会说有意义的GDUFA统计数据仅是指向了错误的方向而已。 虽然ANDA总处理量（指ANDA的最终处置）增加了60件，但其中72件来自于撤销！即使收紧了拒绝接收条件，一年也仅增加了23件拒绝接收。 最令人关注的数据是在GDUFA第2年保持在3665件的积压。2015新财年是绩效指标适用的第一年，尽管仅从2014年10月1日提交的ANDA算起。2014财年遇到迄今最大数量的新ANDA提交，共1473件。但这不应该令任何人感到吃惊，在6月中旬实施“3批，6个月加速稳定性”的要求显然导致了在截止日期前ANDA提交的雪崩。而在接下来的3个月总共仅提交了33件ANDA。我并不期待到2014年12月之前提交量能恢复到正常水平。 2014财年FDA开始报告36个月的ANDA中位批准时间。中位批准时间看起来像是将不断延长。许多积压的ANDA已经等待超过36个月，且继续留在“原地”。我预计目前中位批准时间大约为40个月，并且将会继续延长，如果没有采取激烈措施改变目前ANDA审评的缓慢步伐的话。2013财年和2014财年总计提交2441件新ANDA，意味着1224件支付“积压费”的ANDA仍保留在GDUFA之前的队列中。 OGD称他们达到了所有GDUFA目标，包括关于对新审评人员的招聘和培训。这里的问题是CMC审评。对我来说相当不祥的预兆是，2014年10月7日CDER公布的“关键成员”名单 距离GDUFA第一个5年的中点仅剩6个月的时间，显然，在企业对其GDUFA投资感到满意之前还有很长的路要走。 北京大学药物信息与工程研究中心 - Garth Boehm博士 2014-10-11 OGD Performance – Fiscal Year 2014 OGD's fiscal year ended on September 30 and the final ANDA performance numbers are now out. It is not good news for FDA or for industry. Total GDUFA receipts are now over $600 million and industry's return on that investment is not looking good. What industry cares about, and what drove the establishment of GDUFA, is ANDA approvals. In that regard things continue to get worse as the table below shows.
ANDA Approvals and Tentative Approvals both declined going from GDUFA Year 1 to GDUFA Year 2. So the main, many in industry would say only, meaningful GDUFA statistic is going in the wrong direction. Although the total number of ANDAs dealt with (meaning the FINAL DISPOSITION of an ANDA) increased by 60, 72 of that 60 increase comes from withdrawals! Even tightening the Refuse-to-Receive conditions only added 23 additional refusals for the year. The most concerning figure is the Backlog which stands at 3665 at the end of GDUFA Year 2. The new FY, 2015 is the first year in which performance goals apply, although only to ANDAs filed from October 1, 2014 onwards. FY 2014 saw the largest number of new ANDAs filed ever, 1473. This should be no surprise to anyone, the imposition of the “3 batch, 6 months accelerated stability” requirement in mid-June obviously led to an avalanche of ANDA filings to beat this deadline, indeed only a total of 33 ANDAs were filed in the following 3 months. I do not expect filings to return to normal levels until December 2014. At the start of FY 2014 FDA reported a median ANDA approval time of 36 months. This median approval time looks as though it will continue to increase. Many of the ANDAs in the backlog have been pending for well over 36 months and continue to age “in situ”. I predict that median approval time is currently approximately 40 months and will increase beyond that if drastic action is not taken to change the current glacial pace of ANDA review. 2441 new ANDAs were filed in FY 2013 and FY 2014 combined meaning that 1224 ANDAs that paid the “backlog fee” remain in the queue from before GDUFA. OGD says that they have met all their GDUFA goals, including those related to hiring and training new review staff. The problem here is CMC review. It is rather ominous to me that CDER's “Key Officials” list So we are only 6 months from the midpoint of the first 5 year GDUFA, there is obviously a long way to go before industry will be happy with its GDUFA investment. 识林www.shilinx.com，版权所有，如需转载请注明出处 |
没有提及任何仿制药CMC审评工作组（也没有提及新的药品质量办公室的审评功能）。另一方面的观察是，名单有36页长！