2014-01-05 Lachman CONSULTANTS

祝大家新年快乐，欢迎回到lachman 博客！新年的第一份报告所关注的正是每个仿制药公司所关注的—GDUFA（Generic Drug User Fee Amendments，仿制药使用者付费法案）实施以来，OGD（the Office of Generic Drugs，仿制药办公室）是怎么做的？
仿制药办公室对2013财年及2014财年（截止到目前）有关其工作量的行动做了如下报告。
2013财年，OGD对申请人签发了150个“拒收（refuse-to-receive，RTR）”决定。记住，每件受到拒收的ANDA（Abbreviated New Drug Application, 简化新药申请），都将招致25%的申请费处罚。这一年还有药企撤回了107件ANDA申请。
与2012财年的517件相比，OGD批准了440件ANDA申请，约下降15%。2013财年有95件暂时批准ANDA（Tentatively Approved ANDAs）（这些申请达到了科学和监管的批准要求，但由于专利期限和专营权保护，限制了OGD对其最终批准），相比2012财年的102件，今年批准数降低略超过9%。
OGD在2013财年收到了968件原始ANDA申请，与2012财年收到的1103件原始申请相比，下降约13%。2013财年中，OGD发出了1251封“完全回应函”。而2012年OGD签发的是“审评明确缺陷信”，因此这类活动无法与上一财年实际比较。
OGD完成了1699份DMF（Drug Master Files, 药物主文件）的完全评估。新报告提供了对积压的ANDA修订申请和年申请队列的统计，但OGD尚未公布待批申请数、待批CMC补充及标签补充数的积压数据。如果OGD扩展其报告内容，我们或许会看到这些数字。
OGD日前发布了2014财年头两个月的工作报告，值得注意的是，在这些统计数字中，十月和十一月，OGD签发了40项拒收决定，这对于两个月的时间来说是显著的，可能反映了2013年9月末宣布的对RTR条款的修订。在2014财年的头两个月中，OGD批准了60件ANDA，暂时批准14件，但与此同时接收了99件原始ANDA申请。十二月的数据尚未收入，一旦获得该数据，我们会尽快报道。OGD报告，到目前为止实现了所有的GDUFA目标；追踪行动的数字可能会帮助我们更好地了解OGD所处的位置，但实现真正进展还需假以时日。随着最新报道的敲定OGD升格为超级办公室地位提升和所需的重组力度，以及既定的OGD职员向White Oak园区的搬迁，所有这些都似乎对OGD的产出有不利影响，至少是在短期内。请继续关注本博客对于事件进展的报导！
Lachman CONSULTANTS - Bob Pollock先生 2014-01-02
校译：识林-Kapok 2014-01-06

Office of Generic Drug Activity FY 2013 and FY 2014
Written by Bob Pollock • January 02, 2014

Happy New Year to all and welcome back to the Lachman blog! The first reporting of the year addresses what is on every generic company's mind – how is OGD doing since GDUFA's implementation?

The Office of Generic Drugs reports the following activity relative to its workload in FY 2013 and 2014 (so far).

During FY 2013, OGD issued 150 refuse-to-receive (RTR) actions to applicants. Remember, each ANDA that receives an RTR action incurs a 25% filing fee penalty. The year also saw firms withdraw 107 ANDAs.

OGD approved 440 ANDAs as compared to 517 in FY 2012, which represents a decrease of about 15%. There were 95 Tentatively Approved ANDAs (remember, these are applications that have met scientific and regulatory approval requirements, but OGD is precluded from final approval due to a period of patent or exclusivity protection) in FY 2013 compared to 102 in FY 2012, or a reduction of a little over 9% this year.

OGD received 968 original ANDAs in FY 2013 compared to 1103 in FY 2012, or a reduction in original ANDA submissions of about 13% in 2013. During the year, OGD issued 1251 Complete Response letters. In 2012, OGD was issuing review-specific deficiency letters, so no real comparison can be made to the previous year's activity for this category.

OGD also performed 1699 DMF complete assessments. The new reporting also provides for statistics on submissions of amendments for backlog ANDAs and cohort year applications, but OGD has yet to release backlog figures for the numbers of application pending, CMC supplements pending or labeling supplements. Perhaps we will see those numbers if OGD expands its reporting.

OGD recently reported the first two months activity for FY 2014, and notable among those statistics are that, for October and November, OGD issued 40 RTR actions, which is significant for a two-month period and may reflect the revised RTR provisions announced at the end September 2013 (see previous post here). OGD approved 60 ANDAs and issued 14 Tentative Approvals during the first two months of FY 2014, but received 99 originals during that same time period. The December numbers are not in yet, but we will report on them as soon as they are available. OGD has reported that they have met all GDUFA goals so far; tracking the activity numbers may help us understand better where OGD stands, but it still is going to take time before any real improvement is realized. With the newly reported finalization of OGD's elevation to Super Office status and the reorganization efforts required, as well as the projected move of OGD staff to the White Oak campus this spring, all will likely have a negative impact on OGD output, at least in the short term. Stay tuned to this blog for coverage of the developments!