- Speech by
Scott Gottlieb, M.D.
Commissioner of Food and Drugs - Food and Drug Administration ( May 2017 - April 2019 )
Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
Final All Hands Meeting
April 4, 2019
White Oak, MD
Some opportunities are so special that you know that there’s only a brief period of time in your life when you’re able to do them. I’m sad to leave FDA, but proud of our time together during these past two years. There’s nothing I’d trade for this time.
And I’m not sure there’s too many things that I’d want to have done differently.
We took on hard issues. We pursued meaningful policies. We flexed our regulatory muscle with strength when consumers were put at risk. And we stayed true to the sound, science-based decision making that carefully guides our work.
I know all of this will continue, led by the work of a talented team of center directors; of deputy commissioners Amy Abernethy and Frank Yiannas and Anna Abram; behind the efforts of the immediate office led by Lauren Silvis, and the dedication of all of you.
This agency has a very special “esprit de corps;” driven forward by a deep sense of public health purpose that animates our work and makes it inspiring to pass through these doors each day. That mission provides deep meaning to our efforts, and continuity to the way that we deliver on our commitment to the American people.
I’m proud of what we did together.
We were in it together. All of us. That was important to me. I tried to be honest and open about everything that was going on. About the opportunities and obstacles. I sometimes drew occasional snickers from the press for the stream of statements that we issued. Some reporters even tracked my word count. I got lucky that Twitter decided to double their allowable character count just as I arrived. I hope I got good use out of those extra 140 characters. I’m grateful for the hard work of our Office of Media Affairs for these efforts. It’s important to explain our work and our prerogatives on our terms. To be clear and candid so that the American public understands the challenges we’re seeing, and how we aim to take them on.
And we took on a lot of new efforts. It was all important work. But some things stand out and are especially significant. And I know the impact of these efforts will endure.
In the last two years, we advanced major new policies to reduce the morbidity and mortality associated with tobacco use, putting nicotine at the center of our regulatory efforts and using product regulation and our new authorities under the Tobacco Control Act to regulate the nicotine levels in combustible cigarettes to render them minimally or non-addictive. We confronted a new epidemic of youth use of e-cigarettes that threatens to reverse the dramatic public health gains that we’ve made in recent decades as teen smoking rates declined. And we developed new policies to promote the development of novel cessation products like new formulations of nicotine replacement therapies that can help currently addicted adult smokers quit.
We set the agency in some new directions with respect to our role in addressing the biggest public health crisis that we continue to face – opioid abuse and addiction. We embraced -- as part of our role in addressing this crisis – that we need to rationalize prescribing in order to reduce the rate of new addiction. And we need to weigh the risks associated with illicit use in how we looked and pre- and post-market safety.
We embraced the fact that, as part of our public health mission, we had a role to play in ensuring that we helped advance drug competition in places where Congress expected there to be competition from lower cost generics; and that access to affordable drugs was a public health issue that we must address when we saw brand name drug makers gaming our rules in ways that inappropriately delayed generic entry.
We took new steps to modernize the development process for novel medical technologies like gene therapy and targeted drugs; and we advanced new approaches for the modern and efficient regulation of cell based regenerative medicine, while we also made a robust commitment to go after rogue clinics that leveraged the promise of cell-based medicine to promote unsafe and unapproved products.
We forged a new breakthrough pathway for new devices that promotes safety, and advanced new frameworks for the efficient oversight of novel medical technology like digital health, artificial intelligence devices, and personal genetic tests.
We expanded opportunities for patients with terminal illness to access investigative medicines.
We implemented new measures to improve food safety, to improve our ability to identify and track outbreaks of foodborne illness, and new ways to leverage nutrition and diet as tools for reducing the burden of chronic disease. We fulfilled our established commitment to enact important, new menu labeling requirements and a new nutrition facts label. So, consumers are better informed about their diets and food producers will have greater incentive to compete to offer more healthful products.
We’ve taken notable enforcement actions to confront bad actors that put Americans at risk and approved a record number of generic and novel drugs, and novel devices in 2017. And then we topped our own achievements with new records we set in 2018.
We sought and received historic new resources and authorities from Congress to advance our public health mission, increasing our footprint and authorities to act in the nine International Mail Facilities where our Office of Regulatory Affairs is on the front line of interdiction efforts to stop dangerous, counterfeit drugs and other violative products from entering the country and putting Americans at risk.
We worked with Congress to secure a balanced framework to support our troops through new efforts to advance the development of safe and effective medical products that can help keep American soldiers safer on the battlefield.
We leaned into challenges and we were strong in moments of crisis.
We dedicated ourselves to the recovery of Puerto Rico and averted drug and device shortages in its aftermath. We restored critical functions and protected the public during a historic government shutdown that strained our operations.
These are just a small number of the important things that we did together.
I know that all these undertakings will continue. I know that the agency will advance many other important new efforts in the coming years. The FDA is guided by a great leadership team and a talented professional staff at every level of its ranks.
This was my third time at the FDA and I’ve been around policymaking in Washington almost 20 years now. I’ve worked for and with some great people. And I’ve learned some things along the way. I tried to bring those lessons to what we did together.
No phrase bothered me more than when I heard people say to me they didn’t want to do something important because they wanted to ‘preserve their political capital.’
I was never sure what political capital is.
Can you deposit it in your bank account? Charge it to your credit card?
When you’re in these roles, you have to be willing to challenge powerful interests and policy makers, ask for support, assert your agency’s prerogatives, and defend its conventions if it means fulfilling the mission you’ve sworn to serve.
I used to tell people that when you work in one of these political jobs, you have to be willing to push. There’s no such thing as wearing out your welcome by asking for help in advancing things that are in the best interest of the agency you lead. Because ultimately these things also help advance the public health.
Certain policies may be hard to accomplish. But whatever capital stock of political good will that you’ll have in these jobs -- if that bank of good will is somehow spent down by pushing your prerogatives -- then it’ll be replenished when you’re able to accomplish important things. And you don’t accomplish anything big if you’re not willing to take on hard problems and challenge conventional wisdom.
Another lesson I’ve learned is that you have to lean hard into your biggest challenges.
You have to own your problems and own them publicly.
When a historic hurricane devastated Puerto Rico and threatened the survival of the Island, along with the continued supply of the critical medical products manufactured there, we were hands on in managing the crisis as best we could. We interfaced directly with the Island’s leadership and marshalled resources to help them recover.
When we had terrible deaths of monkeys in our care at one of our research facilities, we worked publicly to address the circumstances that led to the tragedy, and ultimately moved the animals to a shelter to live out their lives in comfort.
When we identified serious risks related to impurities that were found in a class of medicines, we were aggressive in addressing the problems and we were transparent in what we knew, and our shortcomings, issuing multiple statements on the matter.
The public understands that challenges arise, and we can’t prevent every problem or purge every risk. We lose public confidence when we don’t own our problems, address them, and be transparent about our adversities as well as our successes.
Another lesson is that you have to be willing to put yourself on the line in these jobs. Subject yourself to scrutiny. Address problems publicly. And explain the institution’s actions during hard moments. I put myself before the press. And I testified before Congress 19 times in the past two years. The only major Congressional hearing where I didn’t testify was the one hearing on OTC drug reform where Janet Woodcock told me I wasn’t allowed to attend because she wanted to be the agency’s witness.
I don’t think she trusted me to do a good job.
A final lesson is that you have to respect and preserve the mission of the institution and let that guide your ethic. You bring your values to these jobs, not your ideology.
Much was made when I arrived from a conservative think tank. How could I lead a regulatory agency when I was a libertarian. Well that conservative think tank will welcome me back next Monday, even after I tried to assert closer oversight of tattoo ink and presided over the regulation of love as an ingredient in food labels.
An institution like the FDA has a critical mission that is deeply rooted over many years, through the successive toils of many people who pass through these halls. Our mandate is codified in laws and regulations that are the subject of intense scrutiny and debate. You don’t take these jobs to try and disrupt these careful conventions, but to make sure they’re advanced in a manner that best achieves the broader purpose of the institution, and best addresses our challenges and promotes our opportunities.
My perspective on policy and my orientation to our issues shaped some of the problems that I tried to tackle, like market imperfections that drove up drug prices, or challenged the entry of certain innovative areas. But the initiatives we took on were ones we all believed in and cared about advancing. And the solutions came from you.
These are just some of the lessons I’ve taken with me. I’ve been fortunate to serve under some great leaders of this institution. And this institution has been fortunate to be led by talented people in our centers and our front office. It’s led that way still.
I want to thank the Secretary for joining today, and for his support during these past few years. His presence here today was very special and reflects, above all else, the deep admiration and respect that I know he has for our institution and our mission.
I want to thank my immediate office. The FDA’s Chief of Staff Lauren Silvis. Kathleen Quinn who has worked with me during each of my three tours at the agency. Janice Sheehy who has worked with almost every commissioner for the last two decades.
These are just a few of the people who supported me, and the FDA, over the last two years. I owe them and many others a deep debt of personal gratitude.
I want to thank the center directors, with whom I worked closely over the last two years. There wasn’t a day that went by that I didn’t speak to many of them. Mornings, nights, and weekends -- it was through their dedication and collaboration that we advanced many opportunities and solved many challenges. I want to thank all of you.
We’re in an age when science-based institutions, both public and private, sometimes find themselves under intense scrutiny from all spheres. But the FDA remains singular among bodies in my observation. And it enjoys broad bipartisan support in a fashion that few other agencies can lay claim to. That’s a reflection of all of you. The critical work that you do. And the serious and consistent and rigorous way in which you achieve FDA’s purpose. You’ve made it an honor to lead this agency. You made it easy for me to help advance our goals. I’ll miss sharing these experiences with you.
While it is an emotional thing for me to say good bye, I’m delighted that Dr. Sharpless has agreed to step in. I’ve gotten to know Ned well over the past two years. He’s deeply public health minded, and a dedicated physician. I know he shares our mission.
It’s been an honor to serve in this role. I’m in awe of your passion, your professionalism, your patriotism, your commitment to public health, and your dedication to public service. Every single day, I’ve been inspired by our work.
And proud to be part of what this agency will continue to accomplish. You’ll always have my support and admiration. From the bottom of my heart, thank you.