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FDA新任局长Robert:致全体员工的信

2016/02/28 来源:识林
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FDA新任局长Robert 在信中表示“我未来最重要的工作重点是支持和加强FDA卓越的员工团队,从而使我们可以继续保持我们的能力跟上迅速变化的世界。”


FDA第22任局长Robert M. Califf, M.D.

亲爱的同事们,

今天我在这里作为第22任美国食品药品管理局(FDA)局长宣誓就职是我的巨大荣誉。作为一名医生,我的职业生涯一直致力于推动公共卫生和治疗疾病,我能想到的没有比这个受人尊敬的机构更好的地方可以保护和促进公众卫生,这一重要作用在我们强有力的使命声明中被简明扼要地概括。

过去一年担任医疗产品和烟草副局长时,我已经直接看到了在FDA工作的严肃性、重要性和机遇。我们优秀的员工队伍是我们成功的起源和催化剂,这使得我们能够以最高标准履行我们的使命。这样的努力遇到了全球环境巨大变化造成的新的非凡挑战的背景,全球环境的巨大变化已经改变了我们所监管产品的生产、销售和法规几乎各个方面。此外,随着相关产业和实践越来越先进,关于这些产品的信息激增,为我们创造了令人兴奋的挑战,让我们从不断增长的全球资源布局中汲取知识。

好消息是随着这些变化带来了在科学技术革命性发展所提供的巨大机遇。通过拥抱和保持专业知识以跟上在农业、工程、生物医药和信息技术领域的发展步伐,FDA持续确保所有美国民众的安全。我未来最重要的工作重点是支持和加强FDA卓越的员工团队,从而使我们可以继续保持我们的能力跟上迅速变化的世界。这是美国民众众望所归和值得拥有的。

当然,为适应这样一个巨大变化、挑战和机遇的时代,我们还有许多其它需要解决的工作重点。其中一些已经长时间处于进展之中,我期待帮助这些工作冲过最后的终点线。在其它重点领域,我期待随着巩固和加强我们的能力继续开展工作以找到答案。我这里所说的努力,包括诸如具有里程碑意义的《食品安全现代化法案》的继续实施、烟草产品推定法规、帮助疾病治疗研发转化的精准医疗倡议以及打击对全国个人和家庭造成悲剧性后果的日益增长的阿片类药物滥用危机。

上述每个领域,以及我们负责的其它许多不同领域,我们的工作将通过我们科学能力和工作能力的持续发展获得引导、支持和推进。严谨的科学是我们工作的核心之源,是我们能够利用最先进的科学工具提供明智的、基于科学的监管的根本,有助于我们揭开新证据、为创新创造路径、降低成本,并最终使我们能更好地保护美国公众。因此作为局长,我期待尽一切可能进一步发展我们的科学基础。

现在处于“临界点”的一个特定科学领域是产生跨越整个食品、烟草、动物产品和医疗产品领域做出正确决策的证据所需的系统。我们将孜孜不倦的工作,充分利用我国对电子健康记录的投资以及FDA像哨兵和国家器械评估系统这类项目的巨大工作,开发可以在更短时间产生更高质量证据的更高效的系统。

当涉及到寻找FDA正面临的挑战的解决方案,没有比通过参与和联系患者及其家属、照护者和支持者所呈现的更强大的资源。包括他们在我们整个医疗产品连续工作中的观点和声音,从研发到审评和评价再到上市后监督,为提高我们对医疗产品的收益和风险认识提供了机会。

我自己对加强公共卫生的承诺来自于我的个人经验和专业背景。我的家人不仅支持我的工作和研究,还在非常个人的层面帮助我了解疾病和与疾病作斗争的迫切性。他们塑造了我,增强了我在医学和科学的承诺和力量上的信念。他们的爱和指导是一笔巨大的财富,我期待追随公共卫生领域之前处于我今天这个位置的许多伟大领导者们的足迹。

为此,我希望向Stephen Ostroff医师致以我诚挚的敬意和感谢,他于去年担任食品药品代理局长一职。我很高兴Ostroff医师已经同意暂时留在局长办公室以确保无缝过渡。他在公共卫生领域的专业知识,以及他的领导力、协作和对FDA使命的坚定承诺,帮助推进了FDA的工作和声誉。随着我开始了解他,我了解到他不仅是最温和谦逊的人之一,还是最有能力的人之一。很少有人能如他一般沉着冷静的担任这一职位。我代表FDA和公众感谢他。

我对我的职责、新挑战,以及最重要的是,与诸位卓越的FDA员工会面和合作,充满期待。

诚挚地,

Robert M. Califf, M.D.

食品和药品局长

附:英文原文

Dear Colleagues,

It is my great honor to be sworn in today as the 22nd head of the Food and Drug Administration. As a physician whose career has been devoted to advancing the public health and treating disease, I can think of no better place to be than this esteemed agency whose essential role is succinctly captured in our powerful mission statement -- to protect and promote the public health.

Over the last year, while serving as Deputy Commissioner for Medical Products and Tobacco, I’ve seen first-hand the gravity, significance, and opportunity of the work being done at FDA. The genesis and catalyst of our success is our outstanding workforce, which allows us to fulfill our mission at the highest standards. This effort comes against the backdrop of extraordinary new challenges resulting from vast changes in our global environment that have altered virtually every aspect of production, distribution, and regulation of the products we oversee. And in addition, as the related industries and practices have become more sophisticated, the proliferation of information about these products creates an exciting challenge for us as we assimilate knowledge from an increasing array of global sources.

The good news is that alongside these changes have come enormous opportunities afforded by revolutionary advances in science and technology. By embracing and maintaining the expertise to keep pace with these changes in agriculture, engineering, biomedicine and information technology, FDA continues to ensure the safety of all Americans. My single most important priority going forward is to support and strengthen FDA’s remarkable workforce so that we can continue in our ability to keep up with our rapidly changing world. That’s what the American public expects and deserves. Of course, befitting a time of such great change, challenge, and opportunity, we have many other priorities to address as well. Some of these have been a long time in development, and I look forward to helping to move them across the finish line. In other areas of focus I look forward to continuing our work as we strengthen and enhance our ability to find answers. I’m speaking here of efforts like the continued implementation of the landmark Food Safety Modernization Act, the Deeming Rule for Tobacco products, the Precision Medicine initiative, which is helping to transform the development of treatments for disease, and our work to combat the growing opioid abuse crisis that has had such tragic consequences for individuals and their families across our nation. In each of these areas, as well as across the many other diverse areas of our responsibility, our work will be guided, supported, and advanced by the continued development of our scientific ability and capacity. Rigorous science lies at the core of our work, and it is essential that we are able to take advantage of the most advanced scientific tools to allow us to provide informed, science-based regulation. This helps us unlock new evidence, creates pathways for innovation, lowers costs, and, ultimately, allows us to better protect the American public. So as Commissioner I look forward to doing everything possible to further develop our science base. A particular area of science that is now at a “tipping point” is the system needed to generate the evidence we need to make good decisions across the spectrum of food, tobacco, animal products and medical products. We will be working diligently to take advantage of our nation’s investment in electronic health records and FDAs tremendous work with projects like Sentinel and the National Device Evaluation System to develop a more efficient system that can generate much more high quality evidence in a shorter time. When it comes to finding solutions for challenges facing the FDA, there is no greater resource than the one presented through engagement and outreach with patients, as well as their families, caregivers, and advocates. Including their perspectives and voices in our work along the entire medical product continuum, from development to review and evaluation to post-market surveillance, offers opportunities to enhance our knowledge of the benefits and risks of medical products. My own commitment to strengthening public health comes as much from personal experience as from my professional background. My family not only supported my work and research but on a very personal level helped inform my understanding of disease and the urgency of combatting it. They have shaped who I am and reinforced my belief in the promise and power of medicine and science. It is with a great debt to their love and guidance that I look forward to following in the footsteps of the many great leaders in the field of public health who have preceded me in the position I assume today. To that end, I want to offer my sincere respect and gratitude to Dr. Stephen Ostroff, who, for the last year, has served as Acting Commissioner of Food and Drugs. I am pleased that Dr. Ostroff has agreed to remain in the Office of the Commissioner temporarily to ensure a seamless transition. His expertise in the field of public health, and his leadership, collegiality, and deep commitment to the mission of the FDA, has helped advance the work and reputation of the Agency. As I have come to know him, I have learned that he is not only one of the most modest and unassuming people, but also one of the most capable. Few people could have filled the role he did with such aplomb. On behalf of the FDA and a grateful public, I thank him. I look forward to my responsibilities, the new challenges, and most of all, to meeting and collaborating with all of you, our remarkable FDA workforce.

Sincerely,

Robert M. Califf, M.D.

Commissioner of Food and Drugs

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