Scott Gottlieb, M.D., new FDA Commissioner, has made his first remarks to FDA Staff in an FDA All Hands Meeting.
Gottlieb said, “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.”