FDA 专业负责人联名承诺：科学至上
在《今日美国》 9 月 10 日发表的一篇观点文章中，八名 FDA 职业领导联合表达了对于 FDA 基于科学的决策过程以及如何实现这一过程的承诺。他们在文中做出了这样的保证：科学将决定他们的决策。承诺文章的最后，作者们说承诺只代表他们个人，不代表FDA、卫生部和政府。也就是说，他们是以人格和敬业精神，向人民承诺。下面是文章翻译，后附英文原文。
我们致力于在最佳证据的指导下做出决策。我们的方法曾经并且一以贯之的必须保持所有人都可以信赖的黄金标准。
作者：Patrizia Cavazzoni, Peter Marks, Susan Mayne, Judy McMeekin, Jeff Shuren, Steven Solomon, Janet Woodcock 和 Mitch Zeller
我们绝对明白 FDA（与其他联邦机构一样）在政治环境下运行。这是一个现实，我们必须在保持独立性的同时谨慎行事，以确保获得对公众健康的最佳可能结果。当涉及到对于我们监管产品的授权或批准决策时，或者在发现安全问题采取适当行动时，我们和我们的工作人员会在我们做出决策之时，基于我们对科学证据的公正评价，尽最大努力保障公众健康。
保持美国公众对 FDA 的信任至关重要。如果 FDA 信誉由于实际或感知的干扰而丧失，人们将不会依赖 FDA 的安全警告。公众信任度的下降将使消费者和患者对我们的建议产生怀疑，从而在他们应维持或改善健康状况时不太可能参加临床研究或使用 FDA 监管的产品。在正常情况下都是有问题的，而在我们要最终攻克 COVID-19 之际，问题尤甚。如果我们想尽最大努力保护公众健康和挽救生命，那么保护 FDA 的独立性至关重要。
FDA 工作人员致力于促进公众健康。我们是医生、药剂师、护士、工程师、兽医、营养学家、微生物学家、化学家、毒理学家以及许多其他具有共同使命的专业人员和支持人员。我们所有人都将自己的职业生涯献给了公共卫生。多年来，我们遇到很多利益相关者提出的意见或想法，这些意见或想法最初似乎很有希望 , 但是经过合理的科学审评后才发现存在缺陷。这就是我们在医疗产品、食品以及烟草产品的监管方面一直在学习和创新的原因。这就是我们拥有科学方法的原因。这也就是我们拥有 FDA 的原因。
我们将与 FDA 领导一起工作，以维持 FDA 坚定的承诺，以确保我们的决策将继续以最佳科学为指导。我们的方法曾经并且一以贯之的必须保持所有人都可以信赖的黄金标准。我们希望美国民众了解 , FDA 的 17000 名职业员工将继续尽最大的努力，代表他们 , 并以他们的健康和福祉为己任。
本专栏的合著者是 FDA 高级职业管理人员，负责监督 FDA 中心和现场运行的所有工作。这里表达的观点仅是他们自己的观点，并不代表 FDA、卫生部或美国政府的立场。
Patrizia Cavazzoni 是药品审评与研究中心（CDER）的代理主任。Peter Marks 是生物制品审评与研究中心（CBER）主任。Susan Mayne 是食品安全与应用营养中心主任。Judy McMeekin 是监管事务副局长。Jeff Shuren 是器械与放射健康中心（CDRH）主任。Steven Solomon 是兽医医学中心主任。Janet Woodcock是 CDER 主任。Mitch Zeller 是烟草产品中心主任。
Senior FDA career executives: We're following the science to protect public health in pandemic
We are committed to making decisions guided by the best evidence. Our approach has been and must remain the gold standard that all can rely upon.
Patrizia Cavazzoni, Peter Marks, Susan Mayne, Judy McMeekin, Jeff Shuren, Steven Solomon, Janet Woodcock and Mitch Zeller
USA Today September 10, 2020
We absolutely understand that the FDA, like other federal executive agencies, operates in a political environment. That is a reality that we must navigate adeptly while maintaining our independence to ensure the best possible outcomes for public health. When it comes to decisions to authorize or approve the products we regulate, or to take appropriate action when we uncover safety issues, we and our career staff do the best by public health when we are the decision-makers, arriving at those decisions based on our unbiased evaluation of the scientific evidence.
Maintaining the American public’s trust in the FDA is vital. If the agency’s credibility is lost because of real or perceived interference, people will not rely on the agency’s safety warnings. Erosion of public trust will leave consumers and patients doubting our recommendations, less likely to enroll in clinical studies or to use FDA-regulated products when they should to maintain or improve their health. This is problematic under normal circumstances but especially if we are to ultimately overcome COVID-19. Protecting the FDA’s independence is essential if we are to do the best possible job of protecting public health and saving lives.
The FDA staff is dedicated to advancing public health. We are physicians, pharmacists, nurses, engineers, veterinarians, nutritional scientists, microbiologists, chemists, toxicologists, and many other professionals and support staff who share a common mission. All of us have dedicated our professional lives to public health. Over the years we have encountered opinions or ideas brought forward by our stakeholders that have initially seemed promising, only to be found flawed once subjected to sound scientific review. It is why we are always learning and innovating, be it in the regulation of medical products, foods, or tobacco products. It’s why we have a scientific method. And it’s why we have the FDA.
We will work with agency leadership to maintain FDA’s steadfast commitment to ensuring our decisions will continue to be guided by the best science. Our approach has been and must remain the gold standard that all can rely upon. We want the American people to know that the FDA’s 17,000 plus career staff will continue to work to the best of our ability on their behalf, and with their health and well-being as our beacon.
The co-authors of this column are the senior career executives at FDA who oversee all the work of the agency’s centers and field operations. The views expressed here are exclusively their own and do not represent the position of the FDA, the Department of Health and Human Services or the U.S. government.
Patrizia Cavazzoni is Acting Director of the Center for Drug Evaluation and Research. Peter Marks is Director of the Center for Biologics Evaluation and Research. Susan Mayne is Director of the Center for Food Safety and Applied Nutrition. Judy McMeekin is Associate Commissioner for Regulatory Affairs. Jeff Shuren is Director of the Center for Devices and Radiological Health. Steven Solomon is Director of the Center for Veterinary Medicine. Janet Woodcock is Director or the Center for Drug Evaluation and Research (on detail to the Office of the Commissioner). Mitch Zeller is Director of the Center for Tobacco Products.
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