- Speech by
Janet Woodcock, M.D.
Thank you, Denise [RADM Hinton], for that introduction and for everything you do to lead our Office of the Chief Scientist and support the practice of rigorous science at the FDA.
The FDA’s scientific team is a remarkable group of individuals with wide-ranging expertise in disciplines that include chemistry, biology and microbiology, toxicology, nutrition, veterinary science, dentistry, engineering, physics, pharmacy, and nursing -- and that’s just a small sampling.
But even this abbreviated list demonstrates how well equipped the FDA is to respond to the many varied areas of science and public health for which we have regulatory responsibilities.
Today’s FDA Science Forum offers us an opportunity to highlight and pay homage to the work of these scientists.
It also allows us to do a little well-deserved boasting, and to showcase some of the groundbreaking scientists and their scientific work we call on to inform our regulatory decisions.
To give you just one very recent example, I’m delighted to note that Dr. Dionne Price, director of Division of Biometrics IV in the Office of Biostatistics, in CDER’s Office of Translational Sciences, was just elected the 118th president of the American Statistical Association (ASA), to a one-year term to begin in 2022.
Dr. Price has been involved in the FDA response to many public health challenges, including serving on the Antibacterial Drug Development Task Force and as a member of the teams reviewing products to treat Ebola and coronavirus infections. She currently leads cross-cutting, collaborative efforts across FDA to better use complex, innovative trial designs in pharmaceutical drug development.
She also understands, having faced the challenges of being presented with data and interpretations of those data pertaining to the coronavirus pandemic, just how critical it is that statistics is properly used, particularly during public health emergencies.
I first got to know Dionne when she shadowed me for a brief time here at FDA. As both a fine statistician and scientist, and as the first African-American president of the ASA, I know that she will be an excellent scientific leader.
The FDA Science Forum affords the public a chance to get to know and better understand scientists like Dr. Price and some of the work being done in support of our mission to protect and promote public health.
Nearly every aspect of the work we do at the FDA to advance consumer and patient safety relies on the need for rigorous data and good science.
And yet, as prepared and informed as we are, one of the most challenging … and also exciting … aspects of science is that it is rarely static. Indeed, the essence of scientific inquiry is that it is always changing and advancing.
The questions we’re tasked with answering are increasingly complex. And the process of acquiring, reviewing, and evaluating data is a dynamic exercise; we must regularly refresh and expand the evidence on which we base our decisions.
So, our scientists are always looking forward, working to stay ahead of the curve by embracing the newest technologies and tools and incorporating the best possible data.
We’ve certainly seen that ethos on display over the past 15 months, in the agency’s extraordinary response to the COVID-19 pandemic.
During that time, we’ve supported:
• the development and authorization of three vaccines that have met FDA’s robust standards for safety and effectiveness;
• the development of more than 610 COVID-19 drug development programs in the planning stages;
• more than 450 trials reviewed by the FDA;
• nine COVID-19 treatments currently authorized for emergency use, one COVID-19 approved treatment;
• and more than 400 Emergency Use Authorizations covering nearly 800 medical products, including molecular diagnostic, antigen and serology tests, sample collection devices, personal protective equipment (PPE), and ventilators.
We’ve used our scientific expertise to protect people from products that could be dangerous or that are sold with fraudulent claims to prevent or treat the COVID-19 virus, for example, veterinary products that were being improperly redirected for human treatment.
And we developed a data analysis tool to track the incidence of COVID-19 and its impact on the food system and to help ensure the safety and reliability of supply chains.
Even as we have responded to this public health emergency, we have continued to apply our diligent science-based approach to the agency’s regular and critical responsibilities to protect the public health.
To give you just one important example, we recently committed, with the full support of the Administration, to advancing two regulations that will dramatically change the landscape of combusted tobacco products -- one proposed product standard banning menthol in cigarettes and another banning all flavors (including menthol) in cigars to publish as proposed rules within the next year.
What all this work underscores and reaffirms is just how essential and integral science is to the FDA. Quite simply, good science is in our DNA.
But, as I mentioned earlier, like science itself, the FDA cannot and does not remain static.
To continue to be an effective health and consumer protection agency for the 21st Century, we must continually expand our scientific and data capabilities. We are only as good as the data we have to analyze, and the science we have to apply it.
We recently began an important effort to become even better informed, more efficient, and better prepared, having launched the Technology Modernization Action Plan (TMAP) and Data Modernization Action Plan (DMAP).
These initiatives are designed to help us develop enterprise-wide technology platforms in support of our regulatory mission and to make maximum use of data from current and new sources.
In addition, we will continue to focus on hiring and retaining the best scientists to ensure we can continue to operate at world-class levels.
The good news is that this effort will find increasing public support, as more Americans today have a better understanding and appreciation of the importance of science to their lives.
For example, one recent survey found that global confidence in science has hit a new high. The poll, conducted by 3M during February and March of this year, interviewed thousands of people across 17 countries, including the U.S., Brazil, Germany, India, China and Japan. It found that 91 percent of people trust science, up from 86 percent when the poll was first conducted three years ago.
Certainly, part of this increase is due to the public’s reliance on scientists and health experts to help explain and get us through the current pandemic.
I am hopeful that this awareness also includes an understanding of how critical it is that agencies like the FDA have the resources, capacity, and scientific independence needed to continue conducting the state-of the art scientific research, evaluations, and inspections that are necessary to keep the public healthy and safe.
The primary credit for this increase in the appreciation of science goes to the public health scientists here at the FDA and our sister agencies within HHS who have done such incredible work.
I would suggest, however, that there has been another important catalyst over the past year – one individual who has been particularly influential in helping spur this greater understanding and appreciation for science.
And I am delighted and honored that he is here with us today as our guest speaker.
As you all know, Dr. Anthony Fauci has a long and distinguished scientific career. I encourage you to take a look at his full bio or read one of the many hundreds of profiles that have been written about him over the last year or so. But let me give you just a few of the basics.
Dr. Fauci was appointed director of NIAID in 1984. In that role, he continues to oversee an extensive portfolio of basic and applied research to prevent, diagnose, and treat established infectious diseases such as HIV/AIDS, respiratory infections, diarrheal diseases, tuberculosis and malaria as well as emerging diseases such as Ebola and Zika.
Dr. Fauci has advised seven presidents on HIV/AIDS and many other domestic and global health issues. He was one of the principal architects of the President’s Emergency Plan for AIDS Relief (PEPFAR), a program that has saved millions of lives throughout the developing world.
As a rheumatologist, I am particularly aware of Dr. Fauci’s contributions to immunology. As part of his work on immunomodulations, he developed effective therapies for formerly fatal inflammatory and immune-mediated diseases such as polyarteritis nodosa, granulomatosis with polyangiitis (formerly Wegener's granulomatosis), and lymphomatoid granulomatosis. His book on the Vasculidites was often in my hands in the clinic.
Dr. Fauci is the recipient of numerous prestigious awards, including the Presidential Medal of Freedom (the highest honor given to a civilian by the President of the United States) and the National Medal of Science.
I could go on and on.
But perhaps even more significant than these scientific achievements is the role that Dr. Fauci fills today in our national discourse on issues of public health.
That’s because, more than anyone, Anthony Fauci exemplifies the essential importance of letting science be the key determinant in answering and responding to the public health challenges we face. His extraordinary ability to translate complex issues into common sense answers, has helped the public understand that the scientific answer is also the most rational one.
He’s also the guy who the American public trusted to tell the truth about COVID and the most effective ways to deal with it.
It’s no small achievement that nearly every description you read or hear about him includes phrases like “straight-talking,” “down-to-earth,” “common-sense,” “accessible,” and of course “Brooklyn-accented.”
I’ve had the opportunity to work with Dr. Fauci over the years, including most recently in my work on Operation Warp Speed, and I can say that it has been a privilege and an honor.
Dr. Fauci has not just led our response to this pandemic, but at the same time he has helped to make science appreciated and, dare I say it, even cool.
Not since the days when posters of Albert Einstein graced college dorms, have we seen quite this kind of enthusiasm for, and humanizing of scientists and science, particularly those committed to protecting the public health.
I’m sure you’ve all seen the pictures that dot lawns with the message “Thank You Dr. Fauci.” But that’s just the start. I recently saw that one company is making band aids with his picture – they’re called “Fauci ouchis.” That’s appropriate, given that Dr. Fauci helps protect America like a band-aid.
For all of these reasons, I can’t think of a more appropriate speaker for the FDA’s Science Forum.
And so, it is my great pleasure to be able to welcome Dr. Anthony Fauci to the FDA and the FDA’s Science Forum.