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FDA | FDA Centennial
Food and Drug Administration Alumni Association
4th Annual Meeting and Centennial Tribute Program
Andrew C. von Eschenbach, M.D.
Acting
Commissioner of Food and Drugs
This text contains Dr. von Eschenbach's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.
Good afternoon everyone. Thank you, John for your kind introduction. This is my first opportunity as Acting Commissioner to address you in person as FDA Alumni Association members. It’s a very humbling experience to stand before you being entrusted with this great privilege. You have been so dedicated to FDA and accomplished so much. It is one I welcome, especially in this Centennial year. I am honored to participate in your FDA Centennial tribute program and join President Bush in saluting the extraordinary contributions of you – FDA’s Alumni – to the Agency’s mission of protecting and promoting the public health
If one looks at your program it is clear that you have appropriately acknowledged FDA’s remarkable history as a science-based regulatory agency – one that you as alumni have had a hand in creating, and one in which you should all be justifiably proud. You have also heard from your industry panel about issues currently facing the Agency.
It is clear that the Alumni Association is also looking to the future, and I congratulate you on the establishment and endowment of the FDA Centennial Scholarship for the Temple University Master of Science Program in Quality Assurance and Regulatory Affairs. This is indeed a marvelous way to continue the recognition of FDA’s first one hundred years while at the same time helping to train future regulatory scientists.
In the interest of full disclosure I must say that I had nothing to do with the selection of Temple for the endowed scholarship. Although I grew up in Philadelphia, and my wife and brother went to Temple, I have to say they are ecstatic that a University in my hometown was selected for the FDA Alumni Association endowed scholarship. Most importantly we are all pleased with this kind of program that produces the knowledge and skills needed not only by the FDA - but other Federal and state agencies and industry - to make sure we continue to assure safe and effective products in the marketplace.
While I still consider myself to be a relative newcomer to the Agency, like most Americans, I have long been impressed by the vital and challenging work that FDA is called upon to perform. So much so that as NCI Director , the morning after Mark McClellan’s confirmation, we formed the NCI-FDA Interagency Oncology Task Force.
We are all impressed that a century of dedication and hard work on the part of FDA has helped our nation achieve major advances in medical science and public health.
This is a time to honor the accomplishments of the past. It’s also a time to be excited and filled with expectation about our future. Whether its freedom from suffering and death due to disease like cancer, or generations of healthier infants, the FDA must use its proud legacy to ensure an even more impressive future. And it must deliver on that promise to ALL Americans. At its core, the FDA is about people. In that regard, none of the accomplishments that we are celebrating today would be possible without the commitment and dedication of FDA’s staff.
In my short time with the Agency I already have had a few occasions to interact with the FDA Alumni Association, and I have seen the same level of support and dedication in its members as well. FDA needs the continued support of its alumni. I want to reaffirm to you, as President Bush’s nominee to be permanent Commissioner of FDA, my support of the Memorandum of Understanding (MOU) between FDA and FDAAA that was signed on behalf of FDA by my good friend Mark McClellan in 2003.
The work of FDA Alumni Association members in our international programs is crucial for the support of our efforts in harmonization and globalization of regulatory activities. The numerous members from FDAAA who volunteered to provide backup for important Agency activities when FDA staff deployed for Hurricane Katrina was another example of the continued dedication of FDA alumni to the work of the Agency, and I thank you for that.
I have no doubt that the extraordinary record of accomplishment that you are celebrating today will carry on into the decades to come, but it won’t be easy, and we will continue to need and to value the support of our alumni to meet not only the formidable challenges of the immediate future but of the 21st century.
And that is what I want to share with you today, my vision of the FDA of the future.
Life has given me very special and very privileged roles to play: as a physician; as a researcher; as an administrator; four years ago, as Director of the National Cancer Institute; and I hope, if confirmed, as Commissioner of the FDA.
What I have learned throughout all of those various roles and responsibilities is that my purpose has always been the same, and that purpose is to serve patients. I know that your roles and your responsibilities are different, different than mine and different from each other’s. And yet I believe that our roles together have one common purpose.
I, as the Commissioner of FDA, and you, as the FDA alumni, are together in a common purpose and a common commitment: to assure the health and welfare of patients, people, and the public.
My role to lead the FDA is, in fact, a special privilege. Over the hundred years of its existence, the FDA has become — and is — the world’s gold standard to assure the safety and security of the foods we eat; the drugs we take; the biologics and medical devices we depend on; the animal feed and drugs; and cosmetics; and other consumer products that we use.
Although I come at a time when we’re celebrating the past, for me personally, it is even more importantly an opportunity to look to the future, to use this moment to focus not on our past, but to focus on the FDA of the future and the FDA we will create for the 21st century.
And it is in that context of the future that I especially appreciate the opportunity to speak with you this afternoon, focusing on innovation, because we are at a very, very special moment in time — a moment in time that will shape not just the future of the FDA, but I believe will shape the future of biomedical research and of healthcare.
As we share the common purpose and the common vision to serve people, I believe that we are then all bound together in being a part of creating that future, a future in which we will be able, in ways unimaginable even a few years ago, to eliminate the suffering and burden of diseases.
The macroscopic and microscopic world, that long history, has informed and shaped and determined not only what we understand about diseases, but how we have dealt with diseases. Although that seems like ancient history, the fact of the matter is when I began my career at M.D. Anderson in urologic oncology just a few decades ago, the only way I had of detecting the most-common cancer that occurs in men — prostate cancer — was literally what I could feel with the tip of my finger.
We have lived in that macroscopic and microscopic world for almost the entire history of healthcare and food safety. But in the middle of 20th century, with the discovery of DNA, another process of transformation began. Biomedical science began on a journey of innovation, the journey to unravel the very fundamental mechanisms of life and the underpinning of disease processes, and unravel them — not at the macroscopic and microscopic level — but at the molecular level.
And 10 years ago, we really crossed the threshold, in my opinion, into the molecular era, into a time when we can begin to understand the fundamental genetic and molecular mechanisms that are operative not only in the disease process but in the person susceptible to diseases.
And that transformation, unlike the one from macroscopic to microscopic, is so profound and so radical that I call it a metamorphosis: a molecular metamorphosis in which the future of health and healthcare will be no more like the past than a butterfly is like a caterpillar. It is that radical. It is that profound. And it will alter and change not just one thing; it will change everything.
What’s more, the advances in basic science, in medical technology, and in diagnostic and therapeutic products will translate to greater and greater demands on the human capacities within our Agency. So it will be absolutely essential that FDA’s regulatory processes can support the scientific metamorphosis. Our regulatory processes must be predictive, transparent, consistent and efficient.
Based on the new perspective of health and of healthcare that will evolve from the molecular metamorphosis, we are already envisioning a future in which healthcare will be personalized, will be pre-emptive, and will be predictive. And I would add that, with the continuing integration of information technologies and strategies of communication, for the patient, it will become even more participatory.
In the personalized, pre-emptive, predictive, and participatory system of healthcare, we will be able to define the right treatment for the right patient, delivered at the right time, to the right location, and get the predictable right outcome that we will actually be able to visualize and measure in real time.
We will be able to use the tools that science and technology and innovation have been providing for us, and radically transform our entire system, across the spectrum of Discovery, Development, and Delivery — and it will become a much more integrated and continuous process that, in fact, is self-accelerating.
We will use the new tools of molecular medicine to not only define new interventions, but — in the very process of delivering those interventions to patients, we will be using the tools, for example, molecular imaging — that will enable us to begin to understand the biology of diseases in the individual person. And so, delivery becomes, in itself, a platform of discovery.
The discovery and delivery continuum has, within its center, the developmental process. All of the fruits and all the benefits of the tremendous explosion in innovation that’s been occurring in biomedical research — and which has made the molecular metamorphosis possible — fulfill their purpose only when they are translated into interventions and solutions that are applied to patients. So, from that discovery to the delivery continuum, we must look to the bridge of development, the bridge of development that the FDA must undergird and support.
And as we are aware, the bridge of the past will not necessarily and will not, in my opinion, serve us as well as we need to be served in the future.
Looking to the FDA of the future looks to an FDA that will not just be a science-based regulatory agency, but a science-led facilitating agency that helps new products, in a much more rapid rate, in much larger volumes, to come across that bridge of development, in order to be delivered to patients and improve their health and their welfare.
One very important initiative to help us begin to formulate that vision for the FDA of the 21st century is the initiative that was launched in 2004, and which we have now committed to fully implementing: the Critical Path to Personalized Medicine.
I am committed to Critical Path, because it makes it possible for FDA’s regulatory processes to become science-led, as well as science-based. We will still retain all the rigor, all the discipline, all the precision of regulation, but it will be so that things can move faster, rather than slower.
Modernizing medical product development is, and will be, one of my highest priorities at FDA. Implementing Critical Path will enable the FDA to focus on doing the right thing. At the same time, it is also important for FDA to do the right thing in the right way.
And so in addition to the commitment to opportunities such as Critical Path, I will also be committed to making certain that we bring to the FDA efficient, modern, performance-based management tools and techniques, and that we structure the agency in a way that it has a modern information technology infrastructure and business models and business plans that will enable us to effectively support and nurture bringing state-of-the-art opportunities and solutions to people.
We will continue to develop quality systems around our review functions, in order to enhance our capacity to be the cornerstone and the gold standard for modern drug development and review.
And not just human drugs, but also animal drugs to keep our food animals and pets healthy and safe. These systems will also benefit our efforts in food defense and food safety. In the FDA of the 21st century, we will be able to enhance our knowledge and use of foods and nutrition targeted to the individual to prevent many of the chronic disease we know today.
And we will accomplish this through enhanced collaborations with organizations such as yours and all of our stakeholders. FDA is committed to playing its part and integrating and collaborating in a way that, together we develop solutions, solutions that will assure health and wellbeing not only for the American public, but for people around the world.
Before I leave you, I have a presentation to make, if John Villforth will join me at the podium. On behalf of the FDA, and in honor of its centennial, I would like to present to the FDAAA this set of commemorative inspector and investigator badge pins, which represent key junctures in the development of the FDA during its first century.
Thank you.
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