首页 > 资讯 > FDA项目整合计划：更多问题有待回答

出自识林

2016-07-08 Lachman CONSULTANTS

我们在之前的资讯中曾详细介绍过FDA项目整合小组（Program Alignment Group, PAG）计划的背景和目标【识林资讯 - FDA新检查计划之项目整合小组计划】以及FDA器械人员对该计划的评论【识林资讯 - FDA 监管事务办公室检查项目整合计划正在酝酿巨大变革】。2014年2月时任FDA局长的Margaret Hamburg向所有中心和监管事务办公室（ORA）发布了一份决策备忘录，用以制定一项更加协调和有效的运营计划。作为这项任务的结果，各中心和ORA制定了向以不同产品为基础的垂直整合监管构架发展的财年计划。如FDA网站上FDA项目整合药品质量2016财年行动计划中的描述：

“***制定于2015年的药品项目五年计划是一个高层次的多年计划，用以指导为达到局长以不同产品为基础的、垂直整合监管计划的愿景所需的运行变化。***随着FDA过渡到有着明确的引导、连贯的政策和战略发展、精心设计和协调的实施，以不同产品为基础的、垂直整合的监管计划，2016财年行动计划旨在促进运行和项目整合。行动计划的核心内容将包括提高专业化，涉及ORA和各中心的去分层管理决策和流程，共同制定培训方案，新工作规划模型、与合规计划和政策一致和更新的战略实施办法，战略导入方法，实验室优化，以及关于行动计划的内部和外部沟通协调以确保FDA有关药品项目的政策和运行方面统一发出一个声音。”

AFDO年会上报告的进展

2016年6月，FDA ORA高级领导人在120届食品和药品官员协会（AFDO）年度教育会议上介绍了项目整合进度的组成部分：

药品审评和研究中心（CDER）2016财年首次发起对于工作规划的全国性基于风险的倡议，用以决定需要检查国内外哪家企业。FDA的目标是利用量度和信号追踪，制定稳健的、基于风险的、跨所有中心协作的工作计划。其中一些信号包括对检查结果的更加全面的方法，当涉及到对合规的评估时，将企业的多个场地作为一个整体加以考虑。此外，企业文化的概念仍然处于FDA考虑的重要位置。

ORA已经向现场工作人员发布了计划任务，开始建立一个按产品定位的专门工作团队。整合将包括在一个单一产品领域工作的检查员、合规人员和负责人，与产品中心密切合作。这代表了来自全国按产品组织的跨20个ORA地区办公室不分地域驻派的工作人员的行动。

问题

在AFDO会议上介绍的FDA项目整合进展的要点引发了与会者对于设施检查方面的迫切操作性问题，例如：

• 决定设施风险评分，登记在名单上供检查的是什么？
• 如果检查员整合仅接受一种产品的培训，那么生产多种产品的设施是否将接受多重FDA检查？
• 如果企业的一个场地收到FDA 483表或警告信，是否意味着该公司下的其它场地将会受到检查？
• 如果不再是地区结构和联络点，那么企业将如何与按地理区位分布的FDA工作人员联系？
• 整合计划是否意味着在检查期间设施可能会见到或许来自另一地区的新检查员？

对于这些问题还没有现成的答案。会议与会者敦促FDA关于正在前进的组织结构和检查策略方面的看似巨大的变化，与被监管行业开展及时清晰的沟通。有一件事情是肯定的，游戏正在发生变化，而“游戏规则”正在制定中。

Lachman CONSULTANTS - Ricki Chase
编译：识林-椒
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FDA's Program Alignment: More Questions Than Answers
By Ricki Chase | July 6, 2016 原文地址

In February 2014, then FDA Commissioner Margaret Hamburg issued a memorandum directing all Centers and the Office of Regulatory Affairs (ORA) to develop a plan for more collaboration and efficiency in operations. As a result of this mandate, the Centers and ORA have developed fiscal year plans to move toward a distinct commodity-based, vertically-integrated regulatory structure. As further described in part on FDA’s website:

“***The Pharmaceutical Program 5-Year Plan developed in FY15 is a high-level multi-year plan to guide the operational changes needed to reach the Commissioner’s vision of distinct commodity-based and vertically-integrated regulatory programs. *** The FY16 Action Plan is intended to facilitate operational and program alignment as FDA transitions to distinct commodity-based and vertically-integrated regulatory programs with well-defined leads, coherent policy and strategy development, and well-designed and coordinated implementation. Core elements of Action Plans will include increased specialization, de-layered management decisions and processes involving ORA and the Centers, jointly developing training programs, new work planning models, strategic enforcement approaches with aligned and updated compliance programs and policy, strategic import approaches, laboratory optimization, and coordination of internal and external communication on the Action Plan to ensure that FDA speaks with one voice on the policies and operations related to the pharma program.”

In June 2016, FDA’s ORA senior leaders addressed components of the program alignment progress during the 120th Association of Food and Drug Officials (AFDO) Annual Educational Conference in Pittsburgh, PA. For example:

The Center for Drug Evaluation and Research (CDER) initiated for the first time, a fiscal year 2016, national, risk-based initiative for work planning, which determined which firms were to be inspected, both foreign and domestic. The goal of FDA is to use tracking of metrics and signals, to develop robust, risk-based work plans in collaboration with and across all Centers. Some of these signals include a more global approach to inspectional outcomes, considering firms with multiple sites as a whole when it comes to assessing compliance. Further, the concept of corporate culture continues to be at the forefront of FDA’s mind.

ORA has issued programmatic assignments to field staff thus, beginning to establish a dedicated work force aligned by commodity. The alignment would encompass investigators, compliance officers and directors all working in a single commodity area, in close collaboration with the commodity Center. This represents a move from a geographically distinct work force across 20 ORA Districts to an alignment of staff located throughout the country and organized by commodity, regardless of geographical stationing.

These and other highlights of the Agency’s progress under this alignment program presented at the AFDO Conference raised pressing operational questions from attendees pertaining to facility inspections, for example:

• What will determine a facility’s risk score, landing them on the list for inspection?
• Will facilities producing multiple commodities be subjected to multiple FDA inspections if the investigators are aligned and trained in only one commodity?
• If one site under the same ownership receives an FDA Form 483, or a Warning Letter, does that mean all other sites will be inspected?
• How will industry communicate with geographically distributed FDA staff if there is no longer a District structure and point of contact?
• Does this alignment plan mean that facilities may be seeing new investigators during inspections perhaps from a completely different part of the country?

Answers to these questions were not readily available. Conference attendees urged timely, clear communication to the regulated industry regarding seemingly vast changes in the organizational structure and inspectional strategies moving forward. One thing is certain, the game is changing and the “playbook” is in development.

Stay tuned to this blog for future updates and answers to these and other questions as FDA’s plans, policies and procedures are announced.