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出自识林

2014-12-18 Lachman CONSULTANTS

2014年12月11日，仿制药办公室（OGD）代理主任Kathleen (Cook) Uhl博士向所有OGD和CDER外勤工作人员发送备忘录宣布一些正在实施的人事变动和修订以应对OGD将面临申请的显著积压以及如何接近其必须达到的GDUFA目标。

在阅读备忘之前我们先来了解一下。OGD已经花了2年的时间建立审评机器构架。可以说他们不得不从头构建，因为旧的模式和机构并没有设计用来处理现在压在他们身上的为满足雄心勃勃的GDUFA目标而产生的工作量和重负。更重要的是，从备忘的语气和措辞来看，Cook和OGD似乎对简单的满足目标（目前仅适用于积压申请和第3年队列）并不满意；他们希望确保GDUFA第1年和第2年队列（以及2012年10月1日之前的积压申请）通过批准。

显然，OGD拥有足够的经验而且非常清楚地意识到，仅简单地通过签发完全回应函（CRL）来满足GDUFA目标只是缓兵之计。他们不仅知道这一点，而且正在采取行动。我读到的备忘是，尽管他们的目的是满足所有GDUFA目标日期，签发CRL来满足期限合理呢，还是花费一两周或更长的时间使申请获得批准从而不需要再处理另一个周期更好呢。不管怎样，这是我在OGD看待事情的方式，但以我在OGD和企业多年的经验，我相信这条路是最好的且是唯一走向成功的道路。现在让我们来看看备忘录的具体内容。

各位同事，

为GDUFA第3年和首个目标日期作准备，我们很快地做出了许多重大变化。我们搬迁到White Oak，重组成为仿制药超级办公室，建立新的程序和人员构架，启动新的IT平台，为创建新的药品质量办公室（OPQ）作出重大贡献。我们深入的、基础性的改组将获得显著的回报。我为大家在这段过渡期的勇气、耐心和宽容感到自豪。

对于所有第3年提交，我们将使用新IT平台实施审评、管理工作量、跟踪提交、采取监管行动等等。显然，我们仍然需要达到GDUFA目标日期，保持警觉，并确认我们的新系统可以正常运行。这是显著的成就。

虽然为了达到与“积压”（即，2012年10月1日之前的待决ANDA、ANDA增补和ANDA补充申请）相关的GDUFA承诺已经做了大量工作，我们仍需提高工作效率，并将所有第3年之前的提交放在更大的斗车中“搬运”。这将是一项艰巨的任务。将第3年之前的工作量整合进新IT平台和新审评过程是一项大型、繁复的任务。但正如FDA局长Hamburg博士今天早些时候在OGD全体人员面前所提到的，这些提交对于消费者、支付方和企业都是重要的。

在GDUFA中，我们承诺在2017年10月之前对90%的“积压”提交采取行动。我渴望超越GDUFA承诺，在2017年10月之前所有第3年之前的工作量达到稳定状态。为达到稳定状态，我们将专注于批准而不是仅仅是采取行动，改进其它业务流程，提高效率和沟通。更多的细节将于接下来几周推出。

为了领导这些改善，我请Ted Sherwood担任OGD监管运作办公室（ORO）代理主任，12月15日周一生效。Ted在CDER工作已有相当长的时间，最开始在OGD，曾多年担任OPS/OPQ不可或缺的、具有影响力的领导者。他业务精干，他的禀性和领导力对于OPS/OPQ启动和根本上消除过去庞大的未决批准前补充（PAS）和生效变更（CBE）积压极为重要。他因业务流程改进和流程整合以增强审评能力和提高效率而闻名。将他调派到OGD将会在OPQ留下巨大的空缺。尽管如此，调派得到Woodcock博士、余煊强博士以及其他中心和OGD高级领导的支持，因为控制第3年之前的工作量对CDER从全局考虑具有高优先级。而Ted作为这个极其重要位置的掌舵人，请大家欢迎并协助他。

我不能不提及其他ORO领导者到目前为止所作出的大量贡献并在此表示敬意。在过去的数周和数月内，Carol Holquist、Denise McKan和Aaron Sigler在艰苦的环境下做出了不起的工作。我赞赏他们的坚韧、勇敢和辛勤的工作。他们正在建设一个世界级的项目管理团队，并将继续在他们现在的岗位与整个CDER和FDA与仿制药审评行动相关的所有学科合作，对所有第3年之前的ANDA调整并分配目标行动日期（TAD）。Johnny Young和“Kojo” Awuah正在积极应对备案积压。Koung Lee和Ruby Wu正在处理庞大的标签工作和巨大的标签补充积压。Randi Charbonnet和SteveMazella正在协助办公室与其它实施质量审评系统的部门一起，确认和归档所有流程和必要的OGD培训。我真诚地感谢他们在这段特殊时期的领导能力。

鉴于准备GDUFA第3年的迫切需求，Jason Woo基本是“为了团队牺牲个人”。一直以来，他不仅担任OGD业务转型领导者，还是OGD ORO代理主任。我想对他在这些具有挑战性位置的服务表达我的感激之情。行动胜于雄辩，他在承担艰巨任务面前的大公无私显而易见。即日起，Woo博士将会利用它临床、监管以及合规的专业知识为办公室服务，将调任OGD直属办公室（IO）高级医学专员。在此职位上，他将就有关药品生命周期管理与新药办公室（OND）以及其它CDER办公室对接。尤其是，他将推动导致大量ANDA监管行动停滞不前的长期问题。作为我们进一步开发药品监管的产品生命周期模型，这对于OGD和中心都是高优先级的工作。

此外，现在属于OGD IO沟通人员的受控函人员和职能，将迁移并成为监管运作办公室IO的一部分。原来对于“受控函”在IO沟通人员的安排，主要是根据OGD IO的传统职能以及来自企业的沟通类型通常到达OGD IO。GDUFA的实施，尤其是第3 年队列GDUFA目标日期包括来自企业受控函的目标日期。该目标日期与受控函调整相关的工作，更加战略性的与ORO的ANDA提交追踪和监控职能相关，而不是沟通人员。其次，将“受控函”职能移至ORO将有助于协调所有OGD和CDER的GDUFA承诺目标日期行动和职责。感谢“受控函”职员，尤其是Saundra Middleton和Marissa McNall，感谢他们到现在为止在管理受控函职能方面出色的工作，以及他们在适应这一额外的组织变动方面表现出的韧性和谅解。

最后，但并非是不重要的，让我们带有遗憾的感谢即将在12月底退休的Bob West。Bob对仿制药项目的贡献是无与伦比的。他的坚定和判断力指导了我和OGD的许多人。他一直是OGD几代人的良师、公共健康真正的捍卫者、佼佼者。Bob，谢谢你，谢谢你在FDA 33年的服务以及24年致力于仿制药和OGD。

此致，

Cook

Kathleen Uhl, MD

FDA CDER 仿制药办公室代理主任

我确信企业希望OGD事事成功，因为这意味着企业也会获得巨大的成功。

Lachman CONSULTANTS - Bob Pollock先生 2014-12-11
编译：识林-椒 2014-12-18
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Now That the Foundation Has Been Laid, OGD is Making Moves to Crank Up the Machine
Written by Bob Pollock • December 11, 2014

On December 11, 2014, Dr Kathleen (Cook) Uhl, Acting Director, Office of Generic Drugs (OGD) sent the following memo to all OGD and CDER Ops staff announcing some personnel changes and revisions in the way OGD will be approaching the significant backlog of applications and how it will approach the GDUFA goals it must meet.

But before reading the memo, let me say this. OGD has spent two years building the infrastructure of the review machine. If you will, they have had to build it from the ground up, as the old paradigm and machinery was not built to handle the volume of work and the heavy lifting involved to meet the rather ambitious GDUFA goals that are now upon them. But, even more importantly, Cook and OGD appear not happy with simply meeting the goals (now applied only to the backlog applications and year 3 cohort), as can be seen in the tone and language of the memo; they want to assure that the GDUFA year 1 and 2 cohorts (as well as the backlog applications [pre-October 1 2012]) move through to approval.

It is clear, however, that OGD has enough experience and recognizes all too well that meeting GDUFA goals simply by issuing a Complete Response Letter (CRL) only continues to kick the can down the road. It would seem that, not only do they get that, but they are doing something about it. I read into the memo that, although their aim is to meet all GDUFA goal dates, would it be reasonable to issue a CRL to meet the date, or is it better to take a week or two longer and get the approval out so they don’t need to deal with another cycle before doing so. Anyway – that is my take on things at OGD, but from my years of experience, there and in industry, I believe this path is the best and only one towards success. Well enough of my views - take a look at the memo and let me know what you think.

Dear Colleagues,

To prepare for Year 3 of GDUFA and our first goal dates, we made many big changes fast. We moved to White Oak, reorganized and became the Office of Generics (OGD) Super Office, built new program and staffing infrastructure, flipped the switch on a new IT platform, and contributed substantially to the creation of a new Office of Pharmaceutical Quality (OPQ). Our deep, foundational restructuring will pay off dramatically. I am very proud of everyone's grit, patience, and forbearance during this transition time.

For all incoming Year 3 submissions, we are using our new IT platform to conduct reviews, manage workload, track submissions, take regulatory action, and so on. We obviously still need to hit our GDUFA goal dates, and keep our eye on the ball, and acknowledge that our new systems do work. This is a significant accomplishment.

Although much has been done to meet our GDUFA commitment related to the “Backlog” (i.e., ANDAs, ANDA amendments and ANDA supplements pending as of October 1, 2012), we still need to improve our productivity, and “move the freight” on the larger bucket of all pre-Year 3 submissions. This will be a major undertaking. Integrating our pre-Year 3 workload into the new IT Platform and new review processes is a large, diverse and complex task. But these submissions are important to consumers, payers and industry alike, as mentioned by the FDA Commissioner, Dr. Hamburg, at the OGD All Hands earlier today.

In GDUFA, we committed to take action on 90% of “Backlog” submissions before October 2017. I aspire to exceed our GDUFA commitments, and get to steady state on all our pre-Year 3 workload before October 2017. To get to a steady state, we will focus on approvals not actions, and make other business process improvements, to improve our productivity and communications with respect to the pre-Year 3 workload. Additional details will be forthcoming over the next few weeks.

To lead these improvements, I've asked Ted Sherwood to serve as Acting Director of OGD's Office of Regulatory Operations (ORO), effective Monday, December 15. Ted has a long history with CDER, starting in OGD, and he has been an integral and influential leader in OPS/OPQ over the years. His operational acumen, even temperament, and leadership were critical to OPS/OPQ's ability to attack and essentially eliminate their formerly huge pending Prior Approval Supplement (PAS) and Changes Being Effective (CBE) backlogs. He is well known for business process improvement and process integration to expand review capacity and increase productivity. His detail to OGD will leave a big gap in OPQ. Despite that, the detail is highly endorsed by Dr. Woodcock and Dr. Yu, as well as other senior Center and OGD leaders, because getting a grip on the pre-Year 3 workload is a high priority for CDER as a whole. Please welcome Ted, and assist him as he takes the helm in this critically important role.

I would be remiss if I did not recognize and salute the massive accomplishments to date of our other ORO leadership. Carol Holquist, Denise McKan, and Aaron Sigler have done an amazing job under challenging circumstances for the past several weeks and months. I applaud their tenacity, strength and hard work. They are building a world class project management team, and will continue in their current roles working with all disciplines across CDER and FDA involved in generic drug review activities to align on and assign target action dates (TADs) to all pre-year 3 ANDAs. Johnny Young and “Kojo” Awuah are aggressively tackling the filing backlog. Koung Lee and Ruby Wu are addressing the huge labeling workload and kicking out the enormous labeling supplement backlog. Randi Charbonnet and Steve Mazella are assisting the office with identification and documentation of all our processes and necessary OGD training, among other aspects of implementing a quality review system. My sincerest thanks to them for their leadership during this particularly challenging time.

Given the urgent need to prepare for GDUFA Year 3, Jason Woo essentially “took one for the team”. He has been serving not only as OGD Operations Transition Lead, but also as OGD ORO's Acting Director. I want to express my gratitude for his service in these challenging positions. Actions speak louder than words, and his unselfishness in taking on tough assignments speaks for itself. Effective immediately, Dr. Woo will be leveraging his clinical, regulatory, and compliance expertise for the office and will move to the OGD Immediate Office (IO) as a Senior Medical Officer. In this role, he will interface with the Office of New Drugs (OND) and other CDER offices concerning drug product lifecycle management. In particular, he will drive forward many lingering issues that have stalled regulatory action on a number of ANDAs. This is a high priority for OGD and for the Center as we further develop a product lifecycle model for drug regulation.

In addition, the Controlled Correspondence personnel and function, currently located in the Communications Staff in the OGD IO, will move and become part of the Office of Regulatory Operations IO. The original placement of “Controls” with the Communications Staff in the IO was based largely on legacy functions of the OGD IO as well as the types of communications from industry frequently encountered by the OGD IO. Implementation of GDUFA, especially the Year 3 cohort with GDUFA goal dates, includes goal dates for Controlled Correspondence from industry. This goal date related work with Controlled Correspondence aligns more strategically with the ANDA submission tracking and monitoring function of ORO than with the Communications Staff. Subsequently, moving the “Controls” functionality to ORO will facilitate coordination of all of OGD and CDER GDUFA commitment goal date activities and responsibilities. I thank the “Controls” personnel, in particular Saundra Middleton and Marissa McNall, for their excellent work in managing the Controlled Correspondence function to date and their flexibility and understanding in adapting to this additional organizational change.

And last but by no means least, let me acknowledge with regret the upcoming retirement at the end of December of Bob West. Bob’s contributions to the generic drug program are unmatched. His steadiness and judgment have guided me and many others in OGD. He has been a mentor to generations of OGD'ers, a true champion of the public health, and a class act. Thank you, Bob, for your 33 years of service to FDA and 24 years dedicated to generic drugs and OGD.

Sincerely,

Cook

Kathleen Uhl, MD

Acting Director, Office of Generic Drugs, CDER, FDA

I am certain that the industry wishes OGD all the success in the world, as that would mean great success for the industry as well.