Commissioner of Food and Drugs – Food and Drug Administration
Thank you, Ellen [Sigal].
I’m delighted to be with you virtually today.
My admiration for Friends of Cancer Research is profound. As a cancer researcher and clinician, I have experienced first-hand the important role you play in helping to develop new treatments, approaches, and cures.
Thank you for all that you do for countless cancer patients around the world.
I am particularly proud of the strong, ongoing collaborative relationship between FDA and Friends of Cancer Research. This relationship is a model for others.
Working together, we have helped spur innovation that has led to new treatments and care options by employing the best available science and drawing on the best scientific minds.
As you are well aware, cancer research has also helped shape and inform many other types of medical research and spurred the development of new and creative treatments in other areas.
I’d like to start my remarks by taking us back to last year before COVID-19, when a major crisis facing this country was youth use of e-cigarettes. As you know, we had been seeing for several years an alarming increase in the use of e-cigarettes among our youth.
The FDA has been at the forefront of this national crisis. As a cancer doctor who has cared for lung cancer patients, I knew only too well the health implications of nicotine addiction and combustible tobacco use. And we know that young people who experiment with e-cigarettes are more likely to try combustible cigarettes.
September 9, 2020 marked an important day in the public health effort to combat youth e-cigarette use. This day marked the premarket review submission deadline, a milestone for ensuring new tobacco products, including many already on the market, undergo a robust scientific evaluation by the Agency.
We have waited many years for this day, and I am proud of the efforts of Mitch Zeller and his colleagues at CTP to get us to this point.
Companies must now demonstrate that each product meets the applicable statutory criteria for receiving agency authorization, such as whether marketing the product is appropriate for the protection of the public health.
The FDA has been working tirelessly to ensure that we are as prepared as possible to receive, process, and review the applications in a timely manner.
September 9th also marked the day that the data from the 2020 National Youth Tobacco Survey, or NYTS, was published in partnership with the CDC.
There was some good news: an overall decline in youth e-cigarette use with about 1.8 million fewer U.S. youth currently using e-cigarettes compared to last year.
However, there is much work to be done. 3.6 million youth are still current users of e-cigarettes. Moreover, the data also shows an alarming increase in the number of youth who use disposable e-cigarettes.
On September 9th we also issued Warning Letters to manufacturers selling unauthorized ENDS products. I pledge that FDA will continue our aggressive approach to enforcement as well as education.
I want to spend a few moments discussing FDA’s ongoing efforts to combat the COVId-19 pandemic.
At the FDA, we’ve been immersed in a non-stop effort to address this public health crisis on many different fronts. At the same time, we’ve been operating at a faster pace than under normal circumstances.
I want to acknowledge the extraordinary efforts of the FDA staff, who have tirelessly supported the development of safe and effective medical countermeasures, including making sure that our front-line health care workers had, and will continue to have, the necessary protective equipment.
They have provided essential regulatory advice, guidance, and technical assistance needed to advance the development of tests, therapies, and vaccines.
And they have been vigilant in seeking to prevent the sale of fraudulent products that could harm the public.
They have done all this while maintaining the FDA’s focus on applying scientific rigor to any decisions being made, and basing decisions on the data, no matter how quickly these decisions are made.
Remarkably, they have also maintained the FDA’s regular mission-critical work, continuing to meet our other responsibilities, in the cancer space and elsewhere.
We are also using new approaches to increase the amount and type of data we are able to evaluate.
As you probably know, the data from clinical trials represents only a small portion of the clinical experience that is being generated from the care of COVID-19 patients every day around the nation. So, we are turning to new sources.
Clinical data collected outside of traditional clinical trials – also known as “real-world data” – can help accelerate FDA’s understanding of how COVID-19 is affecting patients and help FDA advise product developers on how to optimize the design of their clinical trials.
I am so pleased that the COVID-19 Evidence Accelerator, run by the Reagan-Udall Foundation and Friends of Cancer Research – with participation from FDA – has become a great example of how a large group of stakeholders can come together to advance the science of real-world data and answer discrete research questions that can help us respond to the pandemic.
We continue to work with many different drug manufacturers, and to provide guidance and technical assistance to help expedite the very necessary clinical trials for the development of a vaccine.
And we continue our commitment to speeding the development of a vaccine. I want to assure you that we will not cut corners in any decisions that we make regarding the quality, safety, or efficacy of a vaccine … or, indeed, any medical product.
Any decisions we make, whether about vaccines, therapeutics, or anything else — will be based on science and data, not politics. And these decisions will be made by career scientists at the FDA who are experts in the field.
Our recent guidance on the development and licensure of vaccines underscores our responsibility to the American people to maintain our regulatory independence and to provide a high level of transparency around those efforts.
What this means is that the public can continue to have complete confidence in the work we do.
I am very hopeful that we are moving toward a time when we can resume life as we once knew it.
Meanwhile, we need to continue the common-sense public health measures we’ve learned are effective at stopping the spread and mitigating outbreaks, such as wearing of masks, social distancing, hand-washing, protection of the vulnerable, and avoidance of large indoor gatherings, particularly in bars.
In closing, I want to thank of all of you for your partnership. That partnership substantially helps us in our public health mission.