FDA新局長(zhǎng)Gottlieb博士對(duì)全員的*次講話：今天我倍感榮幸來(lái)到這里，將和大家一起勇?lián)厝巍?/span>

當(dāng)向我們的孩子們解釋我們所做的工作之時(shí)，我們意識(shí)到我們保護(hù)消費(fèi)者和促進(jìn)公共衛(wèi)生的使命是何等的特殊。我的寶貝女孩今年四歲，我的雙胞胎女兒今年七歲。向她們解釋我的新工作時(shí)，我對(duì)她們說(shuō)，爸爸會(huì)和許多叔叔阿姨一起工作，這些叔叔阿姨幫助確保你們服用的藥物會(huì)讓你們感覺(jué)更好，確保你們吃的食物是安全無(wú)害的。

我曾有幸在FDA工作，作為當(dāng)年時(shí)任FDA局長(zhǎng)的麥克萊倫的顧問(wèn)。后來(lái)作為副局長(zhǎng)回到FDA工作。通過(guò)我之前在FDA的兩份工作，我很高興與這個(gè)機(jī)構(gòu)里許多偉大的資深職業(yè)并肩工作并依靠他們的指導(dǎo)。

現(xiàn)在我誠(chéng)惶誠(chéng)恐再次有機(jī)會(huì)為公共服務(wù)，有機(jī)會(huì)與大家一起推動(dòng)FDA保護(hù)消費(fèi)者和促進(jìn)公眾健康這一偉大的使命。

FDA總是面臨巨大的挑戰(zhàn)，因?yàn)樗幱谌绱硕嚓P(guān)鍵問(wèn)題的交匯處。事實(shí)上，人們的生命和生活，毫不夸張地講，*依賴于我們所做的每一件事。保護(hù)患者和消費(fèi)者是我們所做工作的核心。這是FDA的基本使命，我對(duì)之深信不疑。

FDA擁有一個(gè)值得我們所有人驕傲自豪的傳統(tǒng)，那就是都全身心地致力于FDA的特殊使命。史蒂夫·奧斯特羅夫博士高居光榮榜的。 奧斯特羅夫博士先后兩次挺身而出，接受領(lǐng)導(dǎo)FDA跨越過(guò)渡期的挑戰(zhàn)。每次，他都繼續(xù)推進(jìn)FDA捍衛(wèi)公共衛(wèi)生的職責(zé)，并堅(jiān)持其重要的消費(fèi)者使命。我期待著繼續(xù)仰仗奧斯特羅夫博士的經(jīng)驗(yàn)和建議。 像大家一樣，我非常感謝他的貢獻(xiàn)。

展望未來(lái)，我們的面前是一個(gè)充滿巨大希望的新時(shí)代。

我對(duì)我們共同的未來(lái)非常樂(lè)觀不是盲目的，我的信心來(lái)自于很多方面，包括新的科學(xué)機(jī)遇，如基因療法和再生醫(yī)學(xué)，這給我們帶來(lái)希望，我們有可能真正治愈更多的疾病。以及賦予消費(fèi)者力量的新的醫(yī)療器械，使他們能夠更好地了解他們的健康，更好地管理自己的醫(yī)療。

科學(xué)進(jìn)步也為我們做好監(jiān)管工作提供了更好的工具。 許多這樣的工具和資源就是在FDA、在我們的實(shí)驗(yàn)室和像NCTR這樣的地方開發(fā)的。二十一世紀(jì)的挑戰(zhàn)要求我們進(jìn)一步將自己的工作現(xiàn)代化，以充分利用科學(xué)進(jìn)步來(lái)幫助我們，通過(guò)監(jiān)管過(guò)程的更加現(xiàn)代化和更加化，來(lái)更好地保護(hù)消費(fèi)者和增進(jìn)健康。

為此，我們有機(jī)會(huì)通過(guò)法規(guī)事務(wù)廳進(jìn)行的計(jì)劃調(diào)整來(lái)大大提高FDA首要和主要的公共衛(wèi)生保護(hù)作用。隨著法規(guī)事務(wù)廳的任務(wù)變得更加復(fù)雜和更化，我們期待著實(shí)現(xiàn)運(yùn)營(yíng)率，從而提高我們實(shí)現(xiàn)公共衛(wèi)生使命和保護(hù)消費(fèi)者的能力。

新權(quán)力和資源以及科學(xué)的進(jìn)步給予我們開展所有這些工作所需的更好的工具和前景：保障我們的食品和化妝品，改善營(yíng)養(yǎng)，保護(hù)消費(fèi)者和家畜免受抗生素耐藥性等新的威脅。

在這些和許多其它的機(jī)會(huì)中，可能沒(méi)有一個(gè)單一的措施或者我們短時(shí)間內(nèi)創(chuàng)造的產(chǎn)品，可以對(duì)減少疾病和死亡造成深遠(yuǎn)的影響，其程度如同我們減少吸煙那樣。

我們需要加倍努力，幫助更多的吸煙者遠(yuǎn)離香煙。如果不能或不愿意*戒煙，我們需要有科學(xué)基礎(chǔ)來(lái)探索吸引吸煙者使用危害更小的產(chǎn)品的可能性。在任何時(shí)候，我們必須保護(hù)小孩免受煙草使用的危害。

與這些和許多其它機(jī)會(huì)并存，我們也面臨一些挑戰(zhàn)，要求我們繼續(xù)共同努力，向前推進(jìn)，實(shí)現(xiàn)使命。

一方面，太多的消費(fèi)者因?yàn)楦咚巸r(jià)而無(wú)法獲得藥物。我知道現(xiàn)在FDA不在藥物定價(jià)中發(fā)揮直接作用。但是，我們?nèi)匀恍枰扇∮幸饬x的措施來(lái)上市更多的低成本替代藥品，增加競(jìng)爭(zhēng)力，為消費(fèi)者提供更多的選擇。在復(fù)雜的藥物和生物仿制藥方面尤其如此。

我們還需要采取措施確保仿制藥工藝不會(huì)被不適當(dāng)?shù)刈鍪帜_來(lái)推遲競(jìng)爭(zhēng)和影響消費(fèi)者。我希望在接下來(lái)的幾個(gè)星期內(nèi)就這個(gè)話題有更多細(xì)節(jié)。

在其它方面，由于新興的科學(xué)觀點(diǎn)和更好的分析工具，國(guó)會(huì)給了我們一個(gè)明確的任務(wù)，那就是在如何評(píng)估安全性和有效性方面要有前瞻性。實(shí)施“21世紀(jì)治愈法”是當(dāng)務(wù)之急。我們需要確保我們采取措施，以不提高發(fā)展成本或降低創(chuàng)新的方式，促進(jìn)創(chuàng)新和規(guī)范有前途的新技術(shù)領(lǐng)域。我們需要做所有這些事情，而不損害我們保護(hù)公共衛(wèi)生的主要任務(wù)。

在食品安全方面，新的權(quán)力機(jī)構(gòu)和資源以及CFSAN的轉(zhuǎn)型工作明顯改善了確保食物安全的方案。我致力于與CFSAN的高層領(lǐng)導(dǎo)合作，為各位提供所需的資源，做好FSMA要求的工作。我希望在實(shí)施新的食品安全框架方面取得成功。

但毫無(wú)疑問(wèn)，我們zui大的挑戰(zhàn)就是阿片類藥物濫用問(wèn)題。 這是一個(gè)驚人的公共衛(wèi)生危機(jī)。阿片類藥物成癮的流行并不是FDA單獨(dú)能夠解決的問(wèn)題。但是，我們可以在降低新的濫用率方面發(fā)揮重要作用，并為醫(yī)療保健提供者合適的工具，使得阿片類藥物只用于明確適當(dāng)?shù)幕颊撸@樣我們也可以幫助減少新的成癮病例。解決這個(gè)悲劇將是我zui高的首要任務(wù)之一。

現(xiàn)在，我知道FDA已經(jīng)采取了許多重要步驟來(lái)解決阿片類危機(jī)。 但疫情持續(xù)增長(zhǎng)。我將與FDA的職業(yè)領(lǐng)導(dǎo)層合作，在接下來(lái)的幾個(gè)星期里，希望能更多介紹我們?nèi)绾尾扇「辛Φ拇胧?yīng)對(duì)這場(chǎng)危機(jī)。

在解決這些問(wèn)題和其它問(wèn)題時(shí)，我們必須始終以我們的工作為基礎(chǔ)。我們需要確保我們的努力和我們所托付的資源帶來(lái)zui大的公共衛(wèi)生益處。我知道我們只有有限的資源來(lái)做這些艱巨的任務(wù)。而且，基于我以前從事的FDA工作，我也知道，我們以有限的工具和資源完成了很多的工作。

我們需要以患者為中心，以科學(xué)為本。而且，我們必須確保在我們所有的努力中，我們保持監(jiān)管科學(xué)的黃金標(biāo)準(zhǔn)和獨(dú)立的科學(xué)主導(dǎo)的決策，都是由強(qiáng)大的職業(yè)人員領(lǐng)導(dǎo)的。

在我zui近的旅行中，我與許多支持我的參議院議員謀面，與許多代表病人和提供者的領(lǐng)導(dǎo)人交談，我知道在座各位的努力沒(méi)有被他們認(rèn)為是理所當(dāng)然的。

我絕不認(rèn)為諸位的努力是理所當(dāng)然的。

你們都是這個(gè)偉大機(jī)構(gòu)的心臟和靈魂。沒(méi)有你們的辛勤付出，工作不會(huì)被完成。雖然公眾依靠你的工作來(lái)保護(hù)他們，但只有從內(nèi)部看到你們的工作，各位的奉獻(xiàn)和犧牲才是如此清晰。

有些人zui近告訴我，他覺(jué)得這是FDA的一個(gè)充滿不確定性的時(shí)期。但是，我希望各位知悉的是如果我不認(rèn)為有一個(gè)明確的、歷史性的機(jī)會(huì)擺在我們面前，使得我們可以推動(dòng)FDA的使命并幫助美國(guó)人民在科學(xué)和醫(yī)學(xué)上獲得更多的機(jī)會(huì)，我不會(huì)接受這項(xiàng)工作。齊心協(xié)力，我堅(jiān)信我們會(huì)把握住這個(gè)機(jī)會(huì)的。

zui后一點(diǎn)：很多人知道我們是做什么的。 沒(méi)有多少人知道我們?yōu)槭裁催@樣做。 但我知道為什么。而且，我知道你們都知道為什么。這是因?yàn)槊绹?guó)人民需要我們。他們需要安全。 他們需要有治病救人的藥品和產(chǎn)品。他們需要有機(jī)會(huì)改善他們自身的健康。

如果人們無(wú)法獲得這些機(jī)會(huì)，無(wú)法獲得我們提供的消費(fèi)者保護(hù)和公共衛(wèi)生工具，他們就不能過(guò)上有尊嚴(yán)的生活。 我們做我們做的事情，為了更廣大的社會(huì)目的服務(wù)。

這不像任何其它的工作。人們需要我們，我們所有人。我很高興成為這些努力的一部分，將與您合作。我期待著在未來(lái)的日子與在座的眾位見面，并與大家一起履行FDA的特殊使命。

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 inappropriay 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.

    北京松源華興冷凍干燥機(jī)按《藥品生產(chǎn)質(zhì)量管理規(guī)范》、《藥品生產(chǎn)質(zhì)量管理（GMP）實(shí)施指南》及GB/T522 6.1-1996標(biāo)準(zhǔn)等國(guó)家相關(guān)規(guī)定標(biāo)準(zhǔn)設(shè)計(jì)、生產(chǎn)，同時(shí)符合FDA 21CFR 規(guī)范要求。產(chǎn)品國(guó)內(nèi)、遠(yuǎn)銷海外。