2018.01.11 Healthy Innovation, Safer Families FDA's 2018 Strategic Policy Roa...

January 11, 2018

2018年1月11日

I am delighted to share FDA’s 2018 Strategic Policy Roadmap, the product of a close collaboration among the Agency’s centers. This document provides an overview of some of the key priorities we will pursue together to advance FDA’s public health mission.

我很高兴分享FDA2018年的战略政策路线图，它是机构中心之间密切合作的成果。该文件提供了我们将会共同追求的促进FDA公共卫生任务中的一些关键属性的大体概况。

Read the 2018 Strategic Policy Roadmap

参考2018年的战略政策路线图

https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM592001.pdf

Many of these efforts are already underway, and will be further advanced in 2018, while other policies outlined in this document will be initiated during the coming months.

这些措施中的一些已经在进行中，在2018年将会有进一步的改进，同时该文件中的其他政策将会在接下来的几个月中被布起实施。

The countless, critical functi** FDA provides every day to our fellow citizens are, at times, obvious and at other times indiscernible, even to those touched by our efforts. The work we do provides Americans with better ways to improve their health and welfare, helps families protect their children, and enables c**umers to make safe and healthier choices about the products they use and the foods they feed to their families.

FDA每天向公众介绍的重要功能是不计其数的、明显的或者有时候是看不见的，甚至是我们努力所触及的。我们通过更好的渠道向公众提供的这些工作服务以便于他们的健康和福利需求，帮助家庭保护他们的孩子，确保消费者能够对他们使用的产品或者他们的家庭所需食物做出安全和更加健康的选择。

We have selected the specific policy efforts included in this Roadmap because we believe they embody the overall scope and spirit of our collective efforts as we work together to pursue FDA’s public health mission. Each one of us has an important role to play in achieving this mission.

在路线图中我们已经选择了具体的政策措施，因为我们相信它们使概括范围和我们共同努力的集体精神-FDA共同努力追求的公共卫生的使命具体化。

Our work is taking place during an inflection point in both science and policy. We have more opportunity to deliver on the promises of science than at any time before. Gene- and cell-based therapies hold the opportunity to treat a wider range of debilitating disorders, and deliver outright cures to intractable diseases. New gene-based technologies enhance the ability to increase crop and animal yields and identify foodborne and zoonotic outbreaks and trace them to their source. Mobile monitoring can offer patients and providers timelier and more actionable clinical information. More targeted medicines allow human and animal patients to realize more of the benefits of new drugs, with fewer side effects. At the same time, new medical devices are helping to restore mobility to paralyzed patients and allowing more people to live lives that are less hindered from the impact of chronic ailments.

我们的工作是在科学和政策的转折点上进行的。与之前任何时间相比，我们有更多的机会来实现科学承诺。基因和细胞基础疗法在一个很大范围上为治疗造**衰弱的疾病提供了机会，为疑难疗疾病提供了完全治愈的可能。新的基因基础的科学技术增强了提高作物和动物产量的能力，确定食源性和人畜共通疾病暴发并将它们追溯至源头。移动监控能够为患者和供应商提供更加及时和可控的临床信息。更多的靶向治疗药物允许人和动物病患了解新药的更多益处，更少的副作用。同时，新医疗器械正帮助偏瘫患者恢复移动能力，使更多人的拥有的生活更少的受到慢性疾病干扰。

These are just some of the extraordinary advances that are transforming health. But we also face challenges as we strive to ensure that Americans have access to these and other opportunities. Both the time and the cost of medical product development continues to rise for many types of products. We know that the cost of product development can impact how such products are priced, and can be a factor in limiting patients’ ability to get timely access to beneficial new treatments and services. At the same time, FDA faces new public health challenges. Principal among them is the ongoing crisis of opioid addiction. We also continue to face too much avoidable death and disease associated with smoking tobacco; and children are still becoming initiated on, and addicted to, nicotine.

这些仅是改变公共卫生非凡进步中的一部分。同时我们也会面对一些挑战，正如我们正努力确保美国人民能够获得这些或者其他的机会。对许多类型的药品来说，药品研发时间和费用将继续升高。我们知道药品研发费用能够影响该产品的价格，也是限制病人及时获得新疗法和服务的一个因素。同时，FDA面临新的公众卫生挑战。他们中的首当其冲的是阿片类药物成瘾的持续危机。我们也将继续面临更多的可避免与烟草有关的死亡和疾病；儿童仍然开始或已经对尼古丁上瘾。

The work we do over the next few years will define how we advance many of these new and transformational technologies that will enable patients to benefit from platforms like gene and cell therapy, while addressing their novel risks and uncertainties. FDA will play an important role in leveraging science-based ways to improve the efficiency and predictability of the development process, while advancing our ability to make sure that new products have been carefully evaluated for safety. When it comes to new areas like regenerative medicine, gene therapy, and digital health, we will be resp**ible for fully establishing the contemporary regulatory approach for properly evaluating these products, and setting these guidelines in action. In some cases, it is going to require us to modernize our traditional approach to regulation to make sure that our policies are suited to novel challenges.

过去几年的工作会决定我们促进这些新的转型技术，以便确保病患从类似基因和细胞疗法这些平台受益，同时也能了解他们的新风险和不确定性。FDA将在扩充科学基础方式以改善研发过程的有效性和可预测性方面起到一个重要的角色，同时促进我们的能力以确保新产品能够得到相详细的安全性审评。当进入到一个新领域，像再生药、基因疗法、数码健康，我们将为全面建立当代监管途径以便适当的评估这些负责，同时将这些指导原则付诸实践。在一些领域，要求我们将我们的传统途径进行现代化处理，以确保我们的政策适应新的挑战。

Already, FDA’s ability to harness the full potential of these new opportunities has been enhanced due to recent legislation that gives FDA additional resources and authorities to safely cultivate new technologies and scientific discoveries. This includes the 21st Century Cures Act (Cures Act), and the recently enacted FDA Reauthorization Act of 2017. Making sure we leverage these opportunities and advance these critical policy areas is a big part of our focus in 2018 as we continue to execute across our portfolio of high priority public health obligati**, and solidify our fundamental role in protecting c**umers from unsafe products and dishonest marketing.

目前，FDA在驾驭这些机遇的全部潜在性方面的能力已经得到和提高，归因于目前FDA额外的资源和当局可以安全地培养新技术和科学发现方面的法规。这包括21世纪治疗法案和2017年制定的FDA再授权法案。确保我们利用这些机遇和促进这些重要政策领域的发展是2018年我们关注的一个重要部分，例如继续执行我们的高级优先公众健康义务文件夹以及巩固我们在保护消费者远离不安全产品和不诚实市场侵害的根本角色。

Our Roadmap is not intended to be a traditional strategic plan; and it is not an exhaustive list of the important policies that FDA will initiate and pursue over the coming year. In focusing on these selected efforts, we will optimize our resources to achieve clear deliverables that will yield results over the next two years. Publishing this Roadmap is another way that we aim to provide more transparency about the FDA’s policy undertakings to all our stakeholders.

我们的路线图不是一个附加的策略计划，它不是FDA将在接下来一年中即将开始或从事的重要政策的详细清单，我们会优化我们的资源，以实现信息清晰可传达，这将在后续的两年取得成果。颁布该路线图是为了向所有的利益相关者提供关于FDA实施政策透明度的另一种途径。

We aim to secure more advantages for society in the form of more efficient risk management, better access to safe products that extend lives, improved nutrition, broader c**umer choices, and a lower burden of chronic disease in people and animals. At the same time, we will work to empower patients and providers with better information about the safety and effectiveness of new products, so they can tailor treatments to individual medical needs and preferences.

我们的目的是以更加有效的风险管理的模式向社会提供更多的机遇，更好的获得延续生命的安全产品，改善营养，丰富消费者的选择，并且减轻人和动物慢性疾病方面的负担。同时，我们将努力将新药的安全性和有效性方面的更好的信息授权给病患和供应商，以便他们可以为个人的医疗需求和偏好量身定制治疗方案。

These goals – and the work we do together in achieving them – go to the heart of our mission of advancing and protecting public health, while maintaining our commitment to the scientific standards that make FDA a recognized global leader, and a gold standard for product review.

我们共同努力以实现这些目标-我们的使命是促进和维护共众卫生，同时维持我们在科学标准方面的承诺，让FDA成为一个有组织的全球领导者，并成为产品审评的黄金标准。

Scott Gottlieb, MD

Commissioner of Food and Drugs

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