首页 > 资讯 > FDA发布ANDA审评优先级MaPP修订稿

出自识林

2016-03-12 Lachman CONSULTANTS

3月11日FDA发布《MaPP5240.3 原始ANDA、增补和补充审评的优先级》修订稿。MaPP（政策和流程手册）是FDA的内部政策和程序，指导FDA内部工作。这篇MaPP的主要内容是简单易懂的，但有几个问题可能需要进一步澄清。

新修订的MaPP概述了加速审评过程的历史，但没有回溯到非常早的仿制药办公室（OGD）政策和程序指导（38-93及其前身16-90和21-90）。这显然被认为是OGD的古老历史（尽管许多相同的规定适用）。OGD接着解释了一些监管和法律规定，以及在审评过程中的变化和2012年仿制药使用者付费法案对政策的影响。

应认真审查和研究整个MaPP，从而能最好的明白FDA关于优先和加速审评的立场。我想指出一些重要问题：

• 对于快速审评的任何请求或问题首先应当对监管项目经理（RPM）提出。（见MaPP5200.3）
• FDA在某些情况下可自行决定加速审评一件ANDA（例如，药品短缺，公众卫生需要）。
• 如果设施处在需采取官方行动（OAI）状态，优先或加速审评将不被批准，除非有显著的公众卫生原因或可能会产生潜在短缺局面。
• 没有封锁性专利或专营权的潜在首仿药，将获得优先审评（仅含小八条*的申请将不被认为是封锁性专利）。
• 如果第四段申请在审评过程中可以获批（请仔细查看该条规定），如果没有其它ANDA推向市场，该申请有资格获得加速审评。
• 首次提交的ANDA将获得优先权，OGD将尝试在30个月期间（或相关期间）批准或暂时批准以防止可能的180天专营权的丧失。
• 2014年10月1日之后且在最后适用专利到期日期或专营权到期日期一年之内提交的ANDA将不考虑加速批准。
• “在最后适用专利到期日期或专营权到期日期30个月之前提交的ANDA将不考虑加速审评。”这里我有一个问题，如果FDA被迫满足对暂时批准或批准的30个月审评，他们不希望一些额外的窗口（像额外的6个月或36个月）以进一步确保他们能满足目标日期？我猜他们有充分的自信能够满足30个月的审评时钟！
• 当然，标准公共卫生问题、药品短缺问题、PEPFAR（总统艾滋病紧急援救）计划下提交的申请和“灾难性事件”的规定和供应链突然中断属于优先审评。

这篇MaPP对回答企业可以对GDUFA下的优先和加速申请期待些什么大有帮助。这也是GDUFA II谈判正在讨论的要点之一，这MaPP肯定会成为企业评议的起点。

*“如果参照药品提交的专利是使用方法专利，并且不是ANDA寻求批准的使用方法的权利要求”，ANDA申请人可以“声明使用方法专利的权利要求没有这个使用方法”（也称为“小八条”）（FD&C Act 第505(j)(2)(A)(viii)节，同样也参考 21 CFR 314.94(a)(12)(iv)）。

Lachman CONSULTANTS - Bob Pollock先生
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MaPP 5240.3 on Prioritization of Original ANDAs, Amendments, and Supplements Gets a Facelift By Bob Pollock | March 11, 2016

Life is always a picnic and deciding what to bring is sometimes a chore. The key is to assure there are no ants! Well, the generic industry has waited to hear what would be brought to the prioritization picnic and now the third revision of the MaPP 5240.3 lays out the meal. But with every complex meal there are some foods you don’t find appealing. In the case of this MaPP (remember, a MaPP is an internal FDA document that instructs the FDA how they are to do business), things seem largely straightforward, but there are a few issues that may need further clarification.

The new MaPP outlines the history of the expedited review process, but does not go back to the very early days of OGD’s Policy and Procedure Guides (38-93 and its predecessors 16-90 and 21-90). That clearly is considered ancient history by OGD (albeit many of the same provisions apply). OGD goes on to explain some of the regulatory and statutory provisions, as well as changes in the review process and the impact of the Generic Drug User Fee Act of 2012 on the policy.

The entire MaPP (here) should be reviewed and studied carefully so you best understand the FDA position on priority and expedited review. I would, however, would like to point out some important issues.

• The lead for any request for expedited review or questions about expedited review should be addressed to the regulatory project manager (RPM). (See MaPP 5200.3)
• On its own initiative, FDA can decide to expedite review of an ANDA under certain circumstances (i.e., drug shortage, public health need).
• If a facility is under an Official Action Indicated (OAI) status, priority or expedited review will not be granted unless there is a significant public health reason or potential shortage situation that may be created.
• Potential first generics, where there is no blocking patent or exclusivity, will receive priority review (an application containing only a little viii statement will not be considered to be a blocking patent).
• If a PIV application becomes eligible for approval during the review process (review this provision closely), it may become eligible for expedited review if NO OTHER ANDA HAS BEEN BROUGHT TO MARKET UNDER AN ANDA.
• First filer ANDAs will receive priority, and OGD will attempt to approve or tentatively approve within the 30-month period (or relevant period) to prevent potential forfeiture of 180-day exclusivity.
• Applications submitted after 10/1/14 within one year of last applicable patent or exclusivity expiration will not be considered for expedited approval.

“ANDAs submitted more than 30 months in advance of the last applicable patent expiration date or exclusivity date will not be considered for expedited review.” Here I have a problem. If FDA is pressed to meet the 30-month review for Tentative Approval or Approval, wouldn’t they want some additional window (like an additional 6 months or 36 months) to further assure they can meet the date? I guess they are fully confident that they can meet the 30-month clock!

• And, of course, the standard public health issues, drug shortage issues, application submitted under the PEPFAR program and the “catastrophic events” provision, and abrupt discontinuation of supply.

The MaPP goes a long way to answering what industry can expect for priority and expedited review under GDUFA. This is also one of the points being discussed for the GDUFA II negotiations and will certainly be a starting point for industry comments.