首页 > 资讯 > GDUFA听证会—OGD在这条雪道上何去何从？

出自识林

2014-09-18 Lachman CONSULTANTS

2014年9月17日，FDA关于政策发展主办了GDUFA公开听证会。随着各种规模的许多仿制药企业出席，听证会上回荡着一系列反复出现的主题。FDA缺乏沟通和透明度，以及日益增长的设施费扼杀了小型新企业的进入，是来自听众最响亮的抱怨。

GPhA的演讲（由科学和法规事物高级副总David Gaugh, R.Ph演讲）肯定的附和了参会的业界代表表达的关于沟通和透明度的问题。但最令人惊讶的是，GPhA指出平均批准时间从2013年的36个月，根据一些粗略的计算估计平均批准时间2014年上升到43个月（根据可获得数据的89件申请推算估计），同时还请注意2003年的平均批准时间为16个月。GPhA还指出，他们在近几年还没有看到由OGD发布的关于平均批准时间的官方数据（这曾经是OGD绩效的标准之一）。他们的幻灯片脚注中引用了19件ANDA因没有在法定审评时间内获得批准或暂时批准而丧失了180天专营权事实。他们还报告说，10个首仿药的平均批准时间是55个月。

从我在听证会上听到的，小企业抱怨缺乏费用减免，设施费每年评估而ANDA却一直悬而未决，而不是仅在ANDA批准后收取年费，如PDUFA下新药批准收取的设施费。

GPhA赞扬仿制药办公室对第1和第2队列年发布目标行动日期的计划，但同时表示，GPhA的成员真正需要更多的有关未决申请状态的信息，从而使他们能够作出合理的商业决策。行业协会还要求OGD澄清质量源于设计/质量综合概要（QbD/QOS）的要求和期望是什么，并且相对于OGD对ANDA的预期，明确定义“质量是什么”。

迄今为止，OGD在GDUFA这段的雪道已处境艰难，大多数道路是上坡且少有积雪覆盖。我相信OGD正在寻找一些下坡道，但正处于找到那条双黑钻道的困难时期。我想也许这个时候，他们可能甚至不介意在初学者雪道滑下去仅为获取一些额外的石头。虽然我无法参加听证会（我当时在飞机上），当我飞过Silver Spring时我能听到行业的呐喊声。希望事情很快会有转机，因为通过2014年6月15日已经有652名GDUFA雇员占2014财年雇佣目标的90%。当这些人员得到充分的培训和工作时，我们或许可以看到审评文件雪花般在OGD的传真机上飞舞。

Lachman CONSULTANTS - Bob Pollock先生 2014-09-17
校译：识林-椒 2014-09-18

'GDUFA Policy Hearing – Where is the Silver in this Lining?
Written by Bob Pollock • September 17, 2014

On September 17, 2014, FDA hosted the GDUFA Public Hearing on Policy Development. With quite a few generic firms of all sizes represented at the hearing, a series of recurring themes appeared to resound. Lack of communication and transparency from FDA and ever growing facility fees that stifle entry of small new players were the loudest complaints from the audience.

GPhA’s presentation (delivered by David Gaugh, R.Ph., Senior Vice President for Science and Regulatory Affairs) certainly echoed the communication and transparency issues expressed by the industry representatives in attendance. But most surprisingly, GPhA noted that the median approval time for 2013 was 36 months, and, based on some back-of-the-envelope calculations, estimates that that median approval time will rise to 43 months for 2014 (based on an estimate derived from 89 applications for which data was available), also noting that the median approval time in 2003 was 16 months. GPhA also noted that they have not seen an official figure on median approval times (which used to be one of the benchmarks for OGD performance) issued by OGD in a few years. A footnote in their presentation cited to the fact that 19 ANDAs had forfeited 180-day exclusivity for failure to obtain approval or tentative approval within the statutory mandated review time. They also reported that the median approval time for 10 first generic approvals was 55 months.

From what I heard about the hearing, smaller firms complained about the lack of fee waivers and the way that the facility fees are assessed annually while the ANDA is pending, instead of only being charged the annual fee after ANDA approval, as is done with the establishment fee for new drug approvals under PDUFA.

It was not a complete OGD “slam fest” as GPhA did give kudos for the Office of Generic Drugs’ (OGD) plan to issue target action dates for priority ANDAs from cohort years 1 and 2, but at the same time indicated that their members really need more information regarding the status of pending applications so they can make reasonable business decisions. The trade association also asked OGD to clarify what Quality by Design/Quality Overall Summary (QbD/QOS) requirements and expectations are, and also to define clearly “what quality is”, relative to OGD expectations for ANDAs.

So far, it has been rough sledding for OGD during GDUFA, with most of the course being uphill and with little or no snow. I believe that OGD is looking for some downhill racing, but is having a difficult time finding that double black diamond. I think perhaps at this point in time they wouldn't even mind the down slope of the bunny hill just to get some additional momentum going. While I could not attend the hearing (I was on a plane), I could hear the shouts of the generic industry as I flew over Silver Spring. Hopefully, things will turn around soon, as through June 15, 2014 there have been 652 GDUFA hires representing 90% of the hiring goal through FY 2014. When this staff gets fully trained and up and running, maybe we will see reviews flying off the OGD fax machines.