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Hamburg博士:FDA使命的关键—推动创新

首页 > 资讯 > Hamburg博士:FDA使命的关键—推动创新

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Hamburg博士:FDA使命的关键—推动创新
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2013-12-23 FDA Voice

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FDA局长Margaret A. Hamburg博士:FDA使命的关键—推动创新
2013年12月20日
Margaret A. Hamburg, M.D.

Hamburg-blog1.png

确保食品供应的安全性和药品、医疗器械和生物制品的安全性和有效性一直是FDA保护公众健康的核心,也将始终保持核心地位。
但是,论及FDA出于消费者和患者安全性而高度警戒,监督和规制,如果做得好,能够成为整个社会创新的关键驱动力。不管是涉及到一些值得注意的新药研发,或是特定产品的监督,来自于FDA的严谨的监管科学的加入,有助于保障创新的新产品的安全性和有效性;确保这些科学成果迅速、充分地发挥其潜力;并构建一个持续的创新途径。 这就是为什么我们持续改进和使规制政策适应,用以应对和预期会到来的科学机会, 使得可以最好地驾驭这些机会,改善健康和医疗服务。
最近有好多使用这种经过深思熟虑的方法面向创新产品的实例。例如,我们已经建立了突破性治疗药品通道,用于针对患有严重或威胁生命的疾病的患者的比现有治疗药品具有确实改善前景的药品上市。利用这一新通道,我们已经批准两个用于罕见癌症类型治疗和一个用于丙型肝炎的治疗药品。由于很多公司都表现出兴趣,在未来的数月或数周内,可能会有很多的新药通过这一通道。到目前为止,我们已经收到119份请求,并对其中的35个给予突破性治疗药品认定。
另一个在非常不同的领域中的例子是移动医疗应用。在今年早些时候推出与这些器械有关的多份最终指南时,我们采取了慎重和明智的做法。尽管很多移动应用涉及到卫生保健,但器械与放射卫生中心(CDRH)却计划将其规制聚焦于这类移动应用中的一小部分—医疗器械上。我们将这一领域称为“移动医疗应用”,并在基于风险的框架内着手对移动医疗应用的规制。我们认为,通过聚焦于对患者具有较大风险的移动应用保护患者安全,这一方法将会促进创新。
正如最终版医疗应用指南所述,将软件作为医疗器械规制(移动应用属于软件)是基于风险和功能性,而对于功能性,不论应用于什么样的平台,都应该同等对待。例如,用于测量心律帮助医生对患者作出诊断的心电图器械,不论是面包盒大小还是智能电话大小,仍然属于心电图机。对患者造成的风险,以及对执业医生和患者保证其安全有效的重要性,在本质上并无二致。
就在几周之前,FDA批准了四种具有创新性的基因测序仪上市。这些产品中的两种,组成一个系统,使得实验室可开展临床检测,检查个体的基因组成并检测可能造成疾病的异常。 FDA意识到,这些系统从一开始就可以有无数用途,因此采取了基于工具的监管方法,而非专注于具体疾病或是基因组领域。我们评价了这些器械是否可以全面衡量其预期用途检测的准确度、可靠性和精确度,使得在检测结果上具有更大的置信度。这几种基因组测序仪代表了朝着生成可以最终改善患者治疗的基因组信息迈出的重要一步。
我们批准和迎来市场的所有新医药产品都涉及到风险与获益平衡,这些都基于对于硬指标和可以利用的最好的科学的研究与评价。应对不断展开的带来巨大潜力—但也对大家及健康带来现实风险的技术,FDA所承担的责任无比重大。
我们知道,随着更多的技术研发和科学与医学方面的进步,将会有新的和持续挑战涌现。这也正是,为什么FDA在这些新兴领域的规制作用不断发展的原因,有时甚至是在技术本身正在成形的情况下。
但我们的目标将维持不变—帮助促进创新,确保真正具有价值的新医学技术对使用这些技术的公众具备真正价值,有效、安全地应用这些技术来解决公众需求,通过这样的明智规制来保护公众健康。
翻译:识林-Kapok 2013-12-23

Driving Innovation Is a Key Part of Our Mission
Posted on December 20, 2013 by FDA Voice
By: Margaret A. Hamburg, M.D.

Ensuring the safety of the food supply and the safety and effectiveness of drugs, devices and biologics has always been at the core of FDA's responsibility to protect the public health – and always will be.

Margaret Hamburg, M.D.But what is often lost or neglected in discussions about FDA's vigilance on behalf of consumer and patient safety is how this kind of oversight and regulation, when done right, can be a key driver of innovation throughout society. Whether it involves the development of some remarkable new drug or oversight of a particular product, the addition of rigorous regulatory science from FDA helps to safeguard the safety and effectiveness of innovative new products; ensures that these scientific achievements quickly reach their full potential; and builds a pathway for ongoing innovation. That's why we continue to adapt and change regulatory policies in response to – and in anticipation of – scientific opportunities so that they can best be harnessed to improve health and medical care.

There are many recent examples of this thoughtful approach to innovative products. For instance, we have put in place a new breakthrough pathway to market for promising drugs that may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. Using this new approach, we have already approved two treatments for rare types of cancer and one for hepatitis C. And there may be considerably more in the weeks and months ahead because many companies have expressed interest. So far we have received 119 requests for designation and granted 35.

In a very different realm, another example is mobile medical apps. We took a measured and sensible approach that promotes innovation when we finalized guidance related to these devices earlier this year. Although many mobile apps pertain to health, CDRH intends to focus its oversight on a very small subset of those mobile apps that are medical devices. We have called that subset “mobile medical apps” and we are approaching their regulatory oversight within a risk-based framework. We believe this approach will promote innovation while protecting patient safety by focusing on those mobile apps that pose greater risk to patients.

As explained in the final mobile medical application guidance, our regulation of software as a medical device – and a mobile app is software – is based on risk and functionality, and that functionality should be treated the same regardless of the platform on which it is used. For example, an electrocardiography device – an ECG machine – that measures heart rhythms to help doctors diagnose patients is still an ECG machine regardless of whether it is the size of a bread box or the size of a smartphone. The risks it poses to patients and the importance of assuring for practitioners and patients that it is safe and effective are essentially the same.

And, just a few weeks ago, we authorized for marketing four innovative gene-sequencing devices. Two of these products comprise a system that allows laboratories to develop clinical tests that can look at a person’s genetic makeup and detect abnormalities that could be responsible for illness. FDA realized the innumerable uses of these systems from the outset, and rather than focusing on specific diseases or areas of the genome, we took a tool-based regulatory approach. We assessed whether the devices overall measure what they are intended to measure accurately, reliably and precisely so that there can be greater confidence in the test results. These types of genome sequencers represent a significant step forward in the ability to generate genomic information that may ultimately improve patient care.

Each of the new medical products we approve and usher to the market involves a balancing of risks and benefits, which is based on study and evaluation of hard data and the best available science. It is a huge responsibility that FDA is charged with, nowhere more so than when dealing with unfolding technologies that offer enormous potential – but that also may present real risks for people and their health.

We know there will be new and continuing challenges that arise with additional technological developments and advancements in science and medicine. This is why FDA's regulatory role in these emerging areas continues to develop as well, sometimes even as the technologies themselves are taking shape

But our goal remains constant – to protect the public health through smart regulation that helps to enhance innovation and ensure that new medical technologies have real value to the people who will use them, and that they are used effectively and safely to address their needs.

Margaret A. Hamburg is Commissioner of the Food and Drug Administration

原文请见:FDA Voice - Driving Innovation Is a Key Part of Our Mission

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