本文转载自“药时代”。
今天我倍感荣幸来到这里，将和大家一起勇担重任。
当向我们的孩子们解释我们所做的工作之时，我们意识到我们保护消费者和促进公共卫生的使命是何等的特殊。我的宝贝女孩今年四岁，我的双胞胎女儿今年七岁。向她们解释我的新工作时，我对她们说，爸爸会和许多叔叔阿姨一起工作，这些叔叔阿姨帮助确保你们服用的药物会让你们感觉更好，确保你们吃的食物是安全无害的。
我曾有幸在FDA工作，作为当年时任FDA局长的麦克莱伦先生的高级顾问。后来作为副局长回到FDA工作。通过我之前在FDA的两份工作，我很高兴与这个机构里许多伟大的资深职业领袖并肩工作并依靠他们的指导。
现在我诚惶诚恐再次有机会为公共服务，有机会与大家一起推动FDA保护消费者和促进公众健康这一伟大的使命。
FDA总是面临巨大的挑战，因为它处于如此多关键问题的交汇处。事实上，人们的生命和生活，毫不夸张地讲，完全依赖于我们所做的每一件事。保护患者和消费者是我们所做工作的核心。这是FDA的基本使命，我对之深信不疑。
FDA拥有一个值得我们所有人骄傲自豪的传统，那就是领导者都全身心地致力于FDA的特殊使命。史蒂夫•奥斯特罗夫博士高居光荣榜的榜首。 奥斯特罗夫博士先后两次挺身而出，接受领导FDA跨越过渡期的挑战。每次，他都继续推进FDA捍卫公共卫生的职责，并坚持其重要的消费者使命。我期待着继续仰仗奥斯特罗夫博士的经验和建议。 像大家一样，我非常感谢他的贡献。
展望未来，我们的面前是一个充满巨大希望的新时代。
我对我们共同的未来非常乐观不是盲目的，我的信心来自于很多方面，包括新的科学机遇，如基因疗法和再生医学，这给我们带来希望，我们有可能真正治愈更多的疾病。以及赋予消费者力量的新的医疗器械，使他们能够更好地了解他们的健康，更好地管理自己的医疗。
科学进步也为我们做好监管工作提供了更好的工具。 许多这样的工具和资源就是在FDA、在我们的实验室和像NCTR这样的地方开发的。二十一世纪的挑战要求我们进一步将自己的工作现代化，以充分利用科学进步来帮助我们，通过监管过程的更加现代化和更加高效化，来更好地保护消费者和增进健康。
为此，我们有机会通过法规事务厅进行的计划调整来大大提高FDA首要和主要的公共卫生保护作用。随着法规事务厅的任务变得更加复杂和更全球化，我们期待着实现运营高效率，从而提高我们实现公共卫生使命和保护消费者的能力。
新权力和资源以及科学的进步给予我们开展所有这些工作所需的更好的工具和前景：保障我们的食品和化妆品，改善营养，保护消费者和家畜免受抗生素耐药性等新的威胁。
在这些和许多其它的机会中，可能没有一个单一的措施或者我们短时间内创造的产品，可以对减少疾病和死亡造成深远的影响，其程度如同我们减少吸烟那样。
我们需要加倍努力，帮助更多的吸烟者远离香烟。如果不能或不愿意完全戒烟，我们需要有科学基础来探索吸引吸烟者使用危害更小的产品的可能性。在任何时候，我们必须保护小孩免受烟草使用的危害。
与这些和许多其它机会并存，我们也面临一些挑战，要求我们继续共同努力，向前推进，实现使命。
一方面，太多的消费者因为高药价而无法获得药物。我知道现在FDA不在药物定价中发挥直接作用。但是，我们仍然需要采取有意义的措施来上市更多的低成本替代药品，增加竞争力，为消费者提供更多的选择。在复杂的药物和生物仿制药方面尤其如此。
我们还需要采取措施确保仿制药工艺不会被不适当地做手脚来推迟竞争和影响消费者。我希望在接下来的几个星期内就这个话题有更多细节。
在其它方面，由于新兴的科学观点和更好的分析工具，国会给了我们一个明确的任务，那就是在如何评估安全性和有效性方面要有前瞻性。实施“21世纪治愈法”是当务之急。我们需要确保我们采取措施，以不提高发展成本或降低创新的方式，促进创新和规范有前途的新技术领域。我们需要做所有这些事情，而不损害我们保护公共卫生的主要任务。
在食品安全方面，新的权力机构和资源以及CFSAN的转型工作明显改善了确保食物安全的方案。我致力于与CFSAN的高层领导合作，为各位提供所需的资源，做好FSMA要求的工作。我希望在实施新的食品安全框架方面取得成功。
但毫无疑问，我们最大的挑战就是阿片类药物滥用问题。 这是一个惊人的公共卫生危机。阿片类药物成瘾的流行并不是FDA单独能够解决的问题。但是，我们可以在降低新的滥用率方面发挥重要作用，并为医疗保健提供者合适的工具，使得阿片类药物只用于明确适当的患者，这样我们也可以帮助减少新的成瘾病例。解决这个悲剧将是我最高的首要任务之一。
现在，我知道FDA已经采取了许多重要步骤来解决阿片类危机。 但疫情持续增长。我将与FDA的高级职业领导层合作，在接下来的几个星期里，希望能更多介绍我们如何采取更有力的措施应对这场危机。
在解决这些问题和其它问题时，我们必须始终以我们的工作为基础。我们需要确保我们的努力和我们所托付的资源带来最大的公共卫生益处。我知道我们只有有限的资源来做这些艰巨的任务。而且，基于我以前从事的FDA工作，我也知道，我们以有限的工具和资源完成了很多的工作。
我们需要以患者为中心，以科学为本。而且，我们必须确保在我们所有的努力中，我们保持监管科学的黄金标准和独立的科学主导的决策，都是由强大的职业人员领导的。
在我最近的旅行中，我与许多支持我的参议院议员谋面，与许多代表病人和提供者的领导人交谈，我知道在座各位的努力没有被他们认为是理所当然的。
我绝不认为诸位的努力是理所当然的。
你们都是这个伟大机构的心脏和灵魂。没有你们的辛勤付出，工作不会被完成。虽然公众依靠你的工作来保护他们，但只有从内部看到你们的工作，各位的奉献和牺牲才是如此清晰。
有些人最近告诉我，他觉得这是FDA的一个充满不确定性的时期。但是，我希望各位知悉的是如果我不认为有一个明确的、历史性的机会摆在我们面前，使得我们可以推动FDA的使命并帮助美国人民在科学和医学上获得更多的机会，我不会接受这项工作。
齐心协力，我坚信我们会把握住这个机会的。
最后一点：很多人知道我们是做什么的。 没有多少人知道我们为什么这样做。 但我知道为什么。而且，我知道你们都知道为什么。
这是因为美国人民需要我们。他们需要安全。 他们需要有治病救人的药品和产品。他们需要有机会改善他们自身的健康。
如果人们无法获得这些机会，无法获得我们提供的消费者保护和公共卫生工具，他们就不能过上有尊严的生活。 我们做我们做的事情，为了更广大的社会目的服务。
这不像任何其它的工作。人们需要我们，我们所有人。我很高兴成为这些努力的一部分，将与您合作。我期待着在未来的日子与在座的众位见面，并与大家一起履行FDA的特殊使命。
附英文原文：
Dr. Gottlieb’s First Remarks to FDA Staff
Remarks by Scott Gottlieb, M.D.
FDA All Hands Meeting
May 15, 2017
Silver Spring, MD
It’s an honor to be here today, and to be taking on this responsibility with all of you.
You realize how special our mission of consumer protection and public health promotion is when you explain what we do to the children in our lives. My baby girl is four and my twin daughters are seven. Explaining my new job to them, I told them daddy’s going to be working with a lot of people who help make sure the medicine you take makes you feel better, and that the food you eat is safe.
I had the privilege to work at FDA as a senior advisor to Mark McClellan when he served as Commissioner. And then to return to FDA as a Deputy Commissioner. Through my two previous roles in the agency, I’ve had the pleasure to work with – and rely on the guidance of – many great senior career leaders of this agency.
I’m humbled now to have another opportunity for public service and to be working with all of you to advance FDA’s mission of consumer protection and public health promotion.
FDA always faces big challenges because of where it sits at the intersection of so many critical concerns. By virtue of the fact that people’s lives – quite literally – depend on what we do. Patient and consumer protection are at the heart of what we do. And I believe deeply in that fundamental mission of this agency.
FDA has a proud tradition of leaders who’ve dedicated themselves to the agency’s special mission. And Dr. Steve Ostroff stands high on that list. Two times Dr. Ostroff has stepped up to the challenge of leading FDA through periods of transition. Each time, he continued to advance the agency’s public health prerogatives and uphold its vital consumer mission. I look forward to continuing to rely on Dr. Ostroff’s experience and counsel. And, like all of you, I’m immensely grateful for his contributions.
Looking ahead, we sit at a time of great promise.
Among some of the reasons I’m so optimistic about our shared future are new scientific opportunities, like gene therapy and regenerative medicine that give us plausible hope that we might be able to actually cure many more diseases. And new medical devices that are empowering consumers, enabling them to be better informed about their health, and better stewards of their own medical care.
Scientific advances also give us better tools to do our regulatory work. Many of these tools and resources are being developed right here at FDA, in our labs, and at places like NCTR. Twenty-first century challenges require us to modernize how we do our own work to take advantage of advances that can help us better protect consumers and promote health by making the regulatory process, itself, more modern and efficient.
To these ends, we have an opportunity to greatly improve FDA’s primary and principal public health protection role through the Program Alignment being undertaken by the Office of Regulatory Affairs. As ORA’s mandate becomes more complex and more global, we look forward to achieving operational efficiencies that can improve our ability to fulfill our public health mission and protect consumers.
New authorities and resources, along with improvements in science, have given us better tools and prospects to do all of these things: to safeguard our foods and cosmetics, to improve nutrition, and to protect consumers and livestock from emerging threats like antimicrobial resistance.
Among these and many other opportunities, there’s probably no single intervention, or product we’re likely to create in the near future that can have as profound an impact on reducing illness and death from disease as our ability to increase the rate of decline in smoking.
We need to redouble efforts to help more smokers become tobacco-free. And, we need to have the science base to explore the potential to move current smokers – unable or unwilling to quit – to less harmful products, if they can’t quit altogether. At all times, we must protect kids from the dangers of tobacco use.
Alongside these and many other opportunities, we also have some challenges that require us to continue to work together and build on our progress and mission.
For one thing, too many consumers are priced out of the medicines they need. Now, I know FDA doesn’t play a direct role in drug pricing. But we still need to be taking meaningful steps to get more low cost alternatives to the market, to increase competition, and to give consumers more options. This is especially true when it comes to complex drugs and biosimilars.
We also need to take steps to make sure the generic drug process isn’t being inappropriately gamed to delay competition and disadvantage consumers. I hope to have much more to say on this topic in the coming weeks.
In other areas, Congress gave us a clear mandate to be forward-leaning when it comes to how we’ll evaluate safety and efficacy in view of emerging scientific insight and better analytical tools. Implementing the 21st Century Cures Act is a key priority. We need to make sure we’re taking steps to foster innovation and regulating areas of promising new technology in ways that don’t raise the cost of development or reduce innovation. We need to do all of these things without compromising our primary mandate to protect the public health.
When it comes to food safety, new authorities and resources, alongside the transformational work of the people of CFSAN, have visibly improved our programs to ensure the safety of food. I’m committed to working with the senior leadership of CFSAN, to get you the resources you need, to do the job that FSMA requires. I want to build on your successes in implementing the new food safety framework.
But unquestionably, our greatest immediate challenge is the problem of opioid abuse. This is a public health crisis of staggering human and economic proportion. The epidemic of opioid addiction is not a problem that FDA can solve alone. But we have an important role to play in reducing the rate of new abuse, and in giving health care providers the tools to reduce exposure to opioids to only clearly appropriate patients, so we can also help reduce the new cases of addiction. Addressing this tragedy is going to be one of my highest initial priorities.
Now, I know FDA has already taken many important steps to address the opioid crisis. But the epidemic has continued to grow. I’ll be working with FDA’s senior career leadership and in the coming weeks hope to have more to say on how we take even more forceful steps to address this crisis.
In tackling these and other issues, we need to always be risk-based in our work. We need to make sure we’re getting the most public health bang for our efforts and the resources that we’re entrusted with. I know we only have limited resources to do these hard tasks. And I also know, from my prior work at FDA, how much we accomplish with the limited tools and resources we have available to us.
We need to be patient-centric and science-based in everything we do. And, we must make sure that in all our efforts, we maintain the gold standard for regulatory science and independent, science-led decision-making, all led by a strong career workforce.
In my recent travels, meeting with many of the members of the Senate in the run-up to my confirmation, and talking with many leaders, who represent patients and providers, I know that your efforts are not taken for granted by the people I’ve met.
And they’re certainly not taken for granted by me.
You all are the heart and soul of this great agency. The work doesn’t get done without you. And while the public relies on your work in protecting them, it’s only by seeing your work from the inside that your dedication and sacrifice is so evident.
Some of you have told me in recent days that you feel this is a period of some uncertainty for FDA. But, I want you to know I wouldn’t have taken this job if I didn’t think there was a clear and historic opportunity for us to advance FDA’s mission, and to help Americans realize more opportunities from science and medicine.
Working together, I know that we’ll seize that opportunity.
One final thought in closing: A lot of people know what we do. Not as many people know why we do it. But I know why. And, I know you all know why.
It’s because Americans need us. They need to be safe. They need to have medicines and products that work. They need to have opportunities to improve their health.
People can’t live a life of dignity if they don’t have access to these opportunities – if they don’t have access to the consumer protections that we provide and the tools of public health. We do what we do to serve that larger societal purpose.
This isn’t like any other job. People need us. All of us. And I’m delighted to be a part of these efforts, and to be working with you. I look forward to meeting many of you in the days ahead, and working with all of you to fulfill FDA’s special mission.
