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出自识林

2016-05-11 Lachman CONSULTANTS

5月10日联邦公告（FR）发布，FDA正召集公开会议向企业界和公众征询关于可能的使用者付费项目以支持高效的非处方药（OTC）专论审评过程。公开会议将于2016年6月10日举行（FR通告内容）

FDA指出，虽然药品、生物制品和器械的整体审评过程部分由使用者付费资助，而需要处理“成千上万在专论系统下的上市药品”OTC专论过程却没有使用者付费。FR通知中指出：

OTC专论药品审评过程仍是FDA有史以来从事的最大和最复杂的监管计划。拥有26个广阔治疗领域约88个同步规则包含成千上万产品。有大约800个活性成分用于超过1400个不同的治疗用途。FDA需要额外的资源致力于完成专论审评过程，并以更有效和及时的方式解决安全问题。额外的资源也会更好地使FDA考虑含有专论成分的药品创新，例如现有专论成分的新剂型的开发。

专论系统与审评单个药品使用和适应症的药品批准过程有所不同。OTC专论以更一般的形式编写，可能有一组GRASE（一般认为安全有效的）成分可以根据单一通用专论单独或组合使用，或者有时以多种剂型使用。FR通告描述了当前专论过程，讨论了使用者付费产品的优点，并提到了支持初始计划和持续审评的稳定的资源来源的需求。

通告继续指出：

“FDA征询对于以下问题的意见，欢迎公众分享其它任何相关信息。
哪些类型的使用者付费（例如，产品登记费、设施费、申请费，或其它类型的费用）可能适合潜在的专论使用者费计划？
在您的答案中考虑以下内容：

对于专论产品（不同于当前使用者付费计划所涵盖的产品），一般不递交上市前申请，因此有关基于申请付费的方法预计对于专论使用者付费计划会与其它使用者付费计划不同。

有想法的企业行动或行为可能会被对收费的评估而受到打击。

通过使用者付费类型提供的资金的稳定性和可预测性。

在获得使用者付费的同时，FDA通常承诺某些与相关产品有关的FDA行动的绩效目标。从公众健康和申办人角度来看，什么类型的绩效目标可能是重要的？哪些参数可以用来衡量使用者付费计划的成功？”

FDA活动的经费清楚地从全部适当资金转向更多以使用者付费为基础的资金流。虽然这是一种国际现象，看起来像是FDA正在到处利用可得的自有资金以提高效率，反过来，FDA将为使用者付费计划所涵盖的活动提供合理的完成目标。准备好再次打开你的钱包。

Lachman CONSULTANTS - Bob Pollock先生
编译：识林-椒
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FDA Seeking Comments on User Fees for OTC Review
By Bob Pollock | May 10, 2016

In a Federal Register (FR) Notice published today, FDA indicates that it is seeking comments from the industry and the public on a potential user fee program to support an efficient over-the-counter (OTC) to support the OTC monograph review process.

FDA notes that, while overall aspects of the drug, biologics and device review process are funded in part by user fees, the OTC monograph process that deals with “hundreds of thousands of drug products marketed under the monograph system” is not. The FR notice (found here) goes on to say

The OTC monograph drug review process remains one of the largest and most complex regulatory programs ever undertaken at FDA. There are approximately 88 simultaneous rulemakings in 26 broad therapeutic areas encompassing hundreds of thousands of products. There are approximately 800 active ingredients for over 1,400 different therapeutic uses. FDA needs additional resources to work toward finalization of the monograph review process and to address safety issues in a more efficient and timely manner. Additional resources would also better enable the Agency to consider innovations for drug products containing monograph ingredients, such as the development of new dosage forms for ingredients under existing monographs.

The monograph system is a bit different that the drug approval process where a single drug product is reviewed for its use and indications. OTC monographs are written more generally, where there may be a group of GRASE (generally recognized as safe and effective) ingredients that can be used singularly or in combination and sometimes in multiple dosage forms under a single general monograph. The notice describes the current monograph process, discusses the benefits of a user fee product and talks about the need for a stable source of resources to support the program initially and the ongoing review.

The notice goes on to say:

“FDA seeks input on the following questions and welcomes any other relevant information the public would like to share.

What types of user fees (e.g. product listing fees, facility fees, application fees, other types of fees) might be appropriate for a potential monograph user-fee program?

Consider the following in your answer:

For monograph products (unlike for products currently covered by user-fee programs), premarket applications are not generally submitted, and thus the approach regarding application-based fees might be expected to be different for a monograph user fee program compared to other user fee programs.

Desirable industry activities or behavior that might be discouraged by the assessment of fees.

The stability and predictability of the funding provided by the user-fee type.

In conjunction with receiving user fees, FDA typically commits to certain performance goals related to the Agency’s activities with respect to the relevant products. What types of performance goals might be important to consider from a public health and sponsor perspective? What parameters could be measured to gauge the success of a user-fee program?”

Funding for FDA activities are clearly shifting from all appropriate funds to more user fees based streams. While is this an international phenomenon, it looks like the FDA is looking to utilize private funds everywhere it can to improve efficiency and, in turn, will offer reasonable goals for completion of the activities covered by the user fee program. Get ready to open your wallets yet again.