首页 > 资讯 > 两大团体对FDA标签拟议的替代建议

出自识林

2015-03-26 Lachman CONSULTANTS

PhRMA（美国药品研究与制造商协会，Pharmaceutical Research and Manufacturers of America）和GPhA（仿制药协会，Generic Pharmaceutical Association）两大行业团体共同支持一份对于FDA拟议标签规定的替代建议—对安全性标签变更的“加速机构审评”（EAR）。

这两个行业团体认为，只有FDA拥有可以对拟议安全性标签变更做出准确和明智判断的所有信息。例如，FDA存储有来自所有申请人（NDA和ANDA持有人）所有临床试验数据，以及不良事件报告。因此，FDA处于一个最佳位置，评估整体数据，决定任何“新安全性信息”应上升到必要的标签变更水平。单独的申请人仅能看到不良事件报告的一小部分，FDA还拥有访问哨兵系统的全部权限，这使得FDA可以识别处而医疗卫生提供者未能怀疑到的与医药产品相关的共同事件的风险上升。因此，可以更有效地使用哨兵系统同时依靠历史被动报告流程保障公共健康。

EAR计划将要求FDA评估由NDA或ANDA申请人提交的安全性数据报告，并决定这些数据是否构成支持标签变更的“新安全性”数据。FDA将有一系列时间表来做决定，随后将通知所有申请人必须做变更，并建立一个时间表在30天内（或者如果条件允许在更短的时间内）修订标签。通过这种方式，FDA将审评和批准由NDA或ANDA持有人提交的变更，从而允许ANDA申请人使用目前存在的流程（即，就潜在问题通知FDA），但由FDA判断该信息是否上升到需要标签变更的水平。这将确保保护了Hatch-Waxman法案标签规定的同一性（并与Mensing案例中最高法院的判决相一致），而同时以一致的方式向所有消费者提供所需的记录翔实的安全性信息，消除可能存在的显著标签差异—相同产品中一些标签差异可能没有实际的数据支持。

已确定适用于标签变更的“新安全性”信息的快速传播，可通过电子标签实现，这是目前FDA拟议规定的目标。GPhA/PhRMA提出的过程相当简单明了，并且可以消除市场上相同产品按照目前FDA发布的拟议规定的多种不同标签可能发生的混乱。

GPhA/PhRMA简述的过程是：

步骤1. NDA或ANDA持有人要求EAR或FDA自身启动EAR。

步骤2. FDA开始审评所有可获得的安全性数据，并与NDA和ANDA持有人共同讨论可能的标签变更。

步骤3. 如果FDA决定（通过对所有可获得的安全性数据的审评）需要标签变更，FDA直接通知NDA和ANDA持有人最终标签语言的内容（15日之内），并通知NDA和ANDA持有人在30日之内通过电子标签更新其标签。

步骤4. 所有申请持有人在30日内通过电子标签更新标签。

虽然这给FDA增加了更大的负担，但FDA是唯一的一方可以获得所有必要的数据以准确评估标签修订的必要。该组织的全部观点将于3月27日呈交FDA公开会议。

Lachman CONSULTANTS - Bob Pollock先生 2015-03-25
编译：识林-椒 2015-03-26
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Do We Have Your EAR Now?
Written by Bob Pollock • March 25, 2015

In somewhat of a strange bedfellows situation, both PhRMA and GPhA support a proposed alternative to the FDA proposed labeling Rule (see previous posts here, here, here, here, here, here, here, here, and here) called the “Expedited Agency Review” (EAR) for safety label changes.

The two industry groups argue that only the FDA has all of the information to make an accurate and informed judgement as to proposed safety label changes. For instance, FDA is the repository for all clinical trial data, as well as the adverse event reporting from all applicants (NDA and ANDA holder). FDA is thus in the best position to evaluate the totality of data to make a determination that any “new safety information” would rise to the level where a label change would be necessary. Individual applicants only see a fraction of the adverse event reporting and FDA also has full access to the Sentinel System that “will allow FDA to identify an increased risk of common events that healthcare providers may not suspect are related to medical products. Therefore, public health can be protected more effectively by using the Sentinel System and relying far less on the historical passive reporting processes.”

The EAR plan will require that FDA evaluate reports of safety data submitted by an NDA or ANDA applicant and make a determination as to whether that data constitutes “new safety” data that would warrant a label change. The FDA would have a set timeframe to make that decision, would then notify all applicants that a change must be made, and establish a timeframe for revision of the label of 30 days or sooner if the situation warrants. In this manner, then, FDA would review and approve the changes submitted by an NDA or ANDA holder, thus permitting ANDA applicants to use a process that is currently in existence (i.e., to notify the Agency of a potential issue), but it would be the FDA that decides whether the information rises to the level of requiring a label change. This would ensure the sameness of labeling provisions of the Hatch-Waxman Act are preserved (and consistent with the Supreme Court decision in the Mensing case), while at the same time provide required well-documented safety information to all consumers in a consistent manner, and would eliminate the potential for significant labeling differences, some of which may not actually be supported by the data, among the same product.

Rapid dissemination of “new safety” information determined to be appropriate for label changes can be facilitated by e-labeling, which is the goal of the current FDA proposed Rule. The GPhA/PhRMA process is fairly simple and straightforward and will eliminate confusion in the marketplace that would occur with the potential for multiple different labeling of the same product should the FDA Rule publish as currently written.

The process is outlined by the groups to look like this:

Step 1. NDA or ANDA holder requests EAR or FDA initiates EAR on its own.

Step 2. FDA begins review of all available safety data and engages NDA and ANDA holders in discussion of potential label change.

Step 3. If FDA determines (through a review of all available safety data) that a labeling change is required, FDA informs the NDA and ANDA holders of the content of the final labeling language immediately (within 15 days) and instructs the NDA and ANDA holders to update their labeling within 30 days via e-labeling.

Step 4. All application holders update labeling via e-labeling within 30 days.

While this will put a greater burden on the FDA, they are the only party that has access to all of the data necessary to accurately evaluate the need for a label revision. The full views of the organizations will be presented at the March 27, 2015 FDA public meeting.