Remarks on FDA Priorities - 01/11/2018
Remarks on FDA Priorities by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
FDA all hands meeting
White Oak, MD
Jan. 11. 2018
I want to thank you for joining me today -- and for giving me the opportunity to share with you my perspective on some of the efforts that we’ll pursue together in the coming year.
I’ve had the privilege to be at FDA as the Agency’s Commissioner for eight months now. But as many of you know, this is not my first opportunity to serve the Agency.
Some of you, like me, have had the chance to work at FDA – and leave for a time -- only to return to the FDA in a new role.
I can tell you that the time between my service at FDA has only reinforced for me why this is such a special institution.
Many features of the work at FDA influence its singular appeal. If I had to cite one of these factors above all others, it would be the chance we have – each day – to make a consequential and positive impact on people’s lives.
The positive impact we have on public health through our daily work is so ingrained in the FDA culture; so obvious to us; that it’s assumed and almost second nature to many of us. But I can assure you that the vital impact we have on peoples’ lives and wellbeing only happens because of our collective efforts.
We’re all a key part of this enterprise, and contributors to the Agency’s unique mission. Each one of you can influence how we provide families with the protections they need, and the products they require; that can help them protect their families, improve their lives, and enhance their health.
Your ability to exert that influence on any particular day, by doing something very meaningful and very beneficial for consumers and patients across the country is what makes working at FDA so special. And we’ll continue to increase that influence in 2018 by working together on some new goals.
And so, today, I want to outline some of those goals that I’m setting out for us to pursue together in the coming year. Goals that, I believe, reflect our shared public health values; and embody some of the areas that the center directors and other agency leaders have agreed are important priorities.
I’ve laid out these objectives, and some of the specific policies that we’ll pursue to achieve them, in a new Strategic Policy Roadmap that we’re sharing with all of you today. I’ve worked closely with the leadership of the centers on this policy plan.
This Roadmap is not an exhaustive list of all the work that we’ll do together in the coming year. Many high priority efforts have been left out because they were already far along, or might be too new to highlight.
Instead, this Roadmap, and the items highlighted, represents some of the important areas where we’ll focus additional attention this year; as we set out to pursue the FDA’s wider set of public health objectives.
Our work at FDA is taking place during an inflection point in both science and policy. It’s not far-fetched to argue that there has perhaps never been a better moment in the history of science and medicine to be engaged in public health.
We have more opportunity to deliver on the promises of science than at any time before -- and to use new tools and medical advances to alter the trajectory of disease.
Gene therapies and cell-based regenerative medicine hold the opportunity to treat a wider range of debilitating disorders, and deliver outright cures to intractable diseases.
New gene-based technologies are also empowering our ability to increase crop and animal yields and identify foodborne and zoonotic outbreaks and trace them to their source.
Mobile monitoring can offer patients and providers timelier, more actionable clinical information.
At the same time, similar technologies are being used to empower consumers with information and put people more firmly in charge of their diet and health.
And more targeted medicines – and the diagnostic tests to guide them – are allowing human and animal patients to realize more of the benefits of new drugs, with fewer risks.
These are just some of the opportunities we have as a result of new science and technology. But we also face new challenges in securing these and other opportunities for Americans.
Some of these challenges are the result of policy issues.
The price of some of the resulting technologies is one such policy challenge; and the ability of people to continue to access these opportunities. The time and cost of medical product development continues to rise for many types of products. We know that these costs can impact how such products are priced. And in turn, high prices can sometimes be a factor in limiting patients’ ability to get timely access to beneficial new treatments and services.
In some parts of the market, consumers still aren’t getting the benefits of the competition that our policymakers envisioned.
Other challenges are the result of societal harms that we, at FDA, are uniquely positioned to help address.
Principal among them is the ongoing crisis of opioid addiction. FDA has a unique role to play in helping to reduce misuse and abuse of opioids, and facilitate greater access to medication-assisted treatment for people currently addicted to opioids.
In the coming year, I want to direct more of our efforts to encourage wider, appropriate use of safe and effective mediction- assisted therapies. This means encouraging the development of better treatments for addiction.
But it also includes new steps that we can take together to reduce stigma around these therapies, to help promote widespread adoption of safe and effective treatments where we know these medications can help those struggling with addiction transition to lives of sobriety.
We also continue to face too much avoidable death and disease associated with smoking tobacco. And too many children are still becoming initiated on, and addicted to, nicotine.
We’ll focus on reducing harms associated with combustible tobacco, and protecting future generations from addiction.
Empowering consumers to better manage their own health is another critical challenge. Obesity impacts more than one-third of Americans, and is a contributor to heart disease, stroke, type 2 diabetes, and some cancers.
To reduce complications associated with obesity, we can help consumers make well-informed choices through evidence-based information about healthy living and diet, including support delivered through apps or other digital support tools.
These approaches can help make sound nutrition the first line of defense in reducing complications associated with disease.
To achieve this goal, FDA will take new steps in 2018 to implement a comprehensive plan, incorporating a range of new efforts, to leverage dietary information and reliable, easy to use, digital health tools to encourage the development of more healthful food options and healthy lifestyles.
Some of the challenges we face can also be our biggest opportunities; chiefly the role we’ll play in safely advancing some of those new technologies like cell and gene therapy. As part of our Roadmap, we’ll be advancing our comprehensive framework for the development and oversight of gene therapy products. We’ll also be advancing new guidance in areas of unmet medical need, including a suite of guidances that will address neurological diseases like ALS, where we want to promote more innovation.
The work we do over the next few years will define safe and efficient pathways and regulatory checkpoints for advancing many of these new technologies, to enable patients to benefit from innovations in medicine and digital health.
Some of the definitions and policies on how these new technologies will be regulated have already been drafted. But we’re the ones who are charged with implementing these new frameworks. We’re the ones who are going to write the modern rules. And we’ll be on the hook to make sure that we establish guardrails that allow these transformative advances to safely progress, so patients can get access to their potentially lifesaving possibilities, and prevent uncertain risks from becoming manifest.
That’s a big responsibility to deliver on. But I know we are up to the task. At the same time, we’re going to be judged by how we deal with the intractable public health issues plaguing families. Principal among these are addiction to opioids. Other time periods have been defined by epidemics. Ours is going to be described by opioids, and how well we grapple with this crisis.
We’ll continue to take new steps in 2018 to address the opioid crisis, including new enforcement actions to protect consumers.
We also need to take new steps to promote competition and access. One area where we’ll be focusing some new attention is when it comes to biosimilar drugs.
We plan to advance new policies that can promote more competition and utilization of safe, effective, high quality -- and in many cases lower cost -- biosimilar alternatives.
FDA is expanding our ability to address all of these challenges, and to harness the full potential of new scientific opportunities.
Part of our efforts owes to the support we have from Congress.
Recent legislation gives the FDA additional resources and authorities to safely cultivate new technologies and scientific discoveries. This includes the 21st Century Cures Act, and the recently enacted FDA Reauthorization Act of 2017.
We continue to work with Congress to advance FDA’s agenda. This year, I’m hopeful we will be able to advance legislation that modernizes our framework for the regulation of Over-the-Counter (OTC) drugs. A wider availability of more modern OTC options can enable more consumers to have lower cost choices, and give them more control over their health.
The OTC proposal before Congress modernizes FDA’s OTC monograph activities to streamline and improve the timeliness of review activities; to spur innovation on behalf of consumers; and to enable the Agency to better respond to urgent safety issues.
I’m also hopeful that in 2018 we’ll continue to work with Congress to fashion a more modern and efficient approach to how we can assure the analytical and clinical validity of laboratory developed tests. As with other areas of new technology, when it comes to LDTs, we need to fashion a regulatory approach to these innovations that’s tailored to the novel profile of these products.
Making sure we leverage these and other opportunities, confront our many difficult public health challenges, and continue to advance the critical policy agenda we committed to – these are all a big part of our focus in 2018.
We’ll continue to execute across our portfolio of high priority obligations, and to solidify our fundamental role in protecting consumers from unsafe products and dishonest marketing.
We have a lot of hard issues we need to address together. But we’ve never had a better time to leverage the tools of science and public health to address these challenges.
Every day we come into this campus, we all have a chance to advance these goals. Each of you plays an important role in the Agency’s mission. Each of you contributes to this enterprise.
Your work is critical and impactful. Your daily tasks -- taken collectively -- amplify the impact of your individual contributions.
A small ripple we create inside these walls, with our individual contributions, end up distributed across an entire industry or category of health issues. Because of where we sit, these efforts have an outsized influence that’s often global in its reach.
That means we have to take great care in our work. And each and every day I see that that’s exactly what you all do.
Your diligence and commitment to excellence is what makes our work so important, and special. And it’s another reason why I’m grateful, and humbled, to have the chance to work with you again, and to lead the agency into the New Year.