FDA公布2013财年GDUFA绩效报告
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FDA公布2013财年GDUFA绩效报告
笔记 2014-03-01 识林 所有的付费计划（10月1日至次年9月30日）都需按照每个财年为特定的付费计划所设定的目标报告完成情况。2013财年是GDUFA执行以来的第一个整年，这份报告也是FDA向总统和国会递交的第一份绩效报告。诚然，由于审评时间要等到GDUFA 5年执授权的第三年才开始度量，这份报告的内容稍显单薄，但是，还是能够提供一些有趣的信息。 历史上当情况停滞不前时，OGD也一直对审评绩效量度量度冷眼旁观，但是自2015财年起，生产商付费计划将确保将这些情况次向国会汇报（由于报告是公开的，也将向公众汇报）。报告首先介绍，2012年84%的门诊处方为仿制药。随后是仿制药的定义，并附以5年审评绩效量度预览表。 或许2013财年最重要的绩效量度是，OGD应至少雇用GDUFA计划全部职员的25%以上。这份报告称，截至2013年9月30日，已雇用共计291位新职员，即GDUFA计划职员数的31%。这让我们首次得知，GDUFA计划总共雇用约940名新员工。同时也提及使用“自我认定系统”进行设施认定，从而使评估设施付费的评估和支付成为可能。 接下来几页介绍了被视为短板的IT系统和技术，有待通过GDUFA提高。 接着就是最有趣的部分，仿制药审评绩效和两年一度根据风险调整的对行业的cGMP监督。审评绩效部分包括一个刻画关键量度的表（如下页所示）。该表显示，2013财年共提交了992项ANDA申请，71项（7.2%）被拒。有趣的是，与此同时，953封“受控函件”中 有26份（2.7%）要求临床部门提供信息。这意味着现行指南仍存在大量不明确的问题。令人吃惊的是，仅发出12份完全回应函（推测是2013财年立卷的ANDA队列）。最后，截至2013年9月30日，仍有2,867份原始ANDA和1,883份已批准申请补充申请待批。 显然，2013年提交的原始ANDA没有获批，而2013财年提交的265项PAS有53项获批。 积压的ANDA和PAS（2012年10月1日时待批申请）中， 对30%的ANDA及40%的PAS做出首个决定。发出超过1200 多份完全回应函。
下表归纳了2013财年cGMP检查绩效。报告称，FDA仍在努力提高检查频率。
有趣的是，所有接受检查的设施的状态现向公众公开。信息公布在http://www.accessdata.fda.gov/scripts/inspsearch/ 报告中有一部分陈述“质量和透明度倡议”，这是迄今为止，产业界对所采取的的步骤非常不满的领域。 报告最后陈述了同时包括在最初的GDUFA协议书中2013财年的研究重点以及2014财年研究重点。最初的优先级11已经变成了1。我不清楚这一“转变”的原因。此外，与最初的清单相比， 2014财年的研究重点单变小了。 报告最后还有一个有趣的附录，深入解释了报告中使用的术语。要明白OGD使用这些术语时有何考虑，应好好研究这份术语表。 北京大学药物信息与工程研究中心 - Garth Boehm 博士 2014-02-16 GDUFA Performance Report FY 2013 All User Fees programs are required to report on accomplishments against goals set for the particular User Fee program each fiscal year (that is October 1 to September 30). Fiscal Year 2013 is the first full year of GDUFA and FDA has presented its first Performance Report to the President and Congress. Admittedly since review time metrics don’t begin until the 3rd year of the 5 year GDUFA authorization, it lacks a little meat; however there are a few interesting pieces of information. Historically OGD has not been very forthcoming with review performance metrics when things were not improving, but User Fees will from FY 2015 make sure these are reported to Congress (and the public since these reports are public). This report begins with an introduction that states that in calendar 2012 84% of “outpatient prescriptions” were filled with generics. Then follows an explanation of what a generic drug is followed by a table of the 5 year preview performance metrics. Perhaps the most significant FY 2013 performance metrics is that OGD should hire at least 25% over the overall GDUFA program staffing. The report states that as of September 30, 2013 they had hired 291 or 31% of the planned GDUFA staffing. This tells us for the first time that GDUFA plans to hire about 940 new staff in total. They also instituted the “self-identification” system for facility identification to enable facility fees to be assessed and paid. Then follows a few pages on IT systems and technology which was identifies as a weakness to be fixed by GDUFA. Then we get to the most interesting parts, Generic Drug Review Performance and Risk-Adjusted Biennial cGMP Surveillance Industry. The Review Performance section contains a table which describes key metrics (Table shown on next page). This table tells us that 992 new ANDAs were submitted in FY 2013 and 71 (7.2%) were refused. It is interesting to note that there were 953 Controlled Correspondences in the same period of which 26 (2.7%) required input from the clinical division. This indicates that there are still a very large number of issues that are not clear from current guidance. What is surprising is that only 12 Complete Response Letters were issues (presumably for the ANDAs filed in this FY 2013 cohort). Finally there were as of September 30, 2013 2,867 original ANDAs pending and 1883 Prior Approval Supplements pending. Apparently no original ANDAs submitted in 2013 were approved and 53 PAS of the 265 submitted in FY 2013 were approved. Of the ANDA and PAS backlog (pending on October 1, 2012) 30% of the ANDAs and 40% of the PASs received a first action. Over 1200 Complete Response letters were issued.
On cGMP Inspections, the following table summarizes the FY 2013 performance. The report states that FDA is still gearing up to increase inspectional frequency.
* A facility indentified as producing both a generic FDF and generic API was counted as FDF. On cGMP Inspections, the following table summarizes the FY 2013 performance. The report states that FDA is still gearing up to increase inspectional frequency. It is interesting to note that the status of any inspected facility is now publically available. This information can be found at http://www.accessdata.fda.gov/scripts/inspsearch/ There is a section addressing “Quality and Transparency Initiatives”, an area where Industry is very unhappy with the steps taken to date. Finally the Report addresses FY 2013 Research priorities which were included in the initial GDUFA agreement letter and the FY 2014 research priorities. This is an area that I find somewhat mystifying. The original priority number 11 has become priority number 1. The mechanism of this “transformation” is unclear to me. Also the FY 2014 list of research priorities is small compared to the original list. There is an interesting appendix that explains many of the terms used in some depth. This list should be studied to shed light on what OGD is thinking when they use many of these terms. |