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Andrew C. von Eschenbach, M.D. - Food and Drug Law Institute

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.

Speech before
Food and Drug Law Institute Annual Conference

Remarks by
Andrew C. von Eschenbach, M.D.

Acting Commissioner of Food and Drugs

April 6, 2006

Good morning, ladies and gentlemen. Thank you, Martin for your kind introduction. I appreciate the opportunity to come before you this morning, during a meeting where you have the chance to consider and contemplate a century of accomplishment by the FDA. It is an opportunity to reflect on a rich past, to acknowledge the past and celebrate the past — to consider how 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; animal feed and drugs; and cosmetics; and other consumer products that we use. It is a time to value, respect, and appreciate the FDA’s vigilance over regulatory processes and its core principles of science and protection: principles that will be maintained, principles that will never be compromised, principles that must never be undermined.

For me to come to the FDA and to lead the agency as its Acting Commissioner at this time of history and celebration is, indeed, a special privilege. And, if confirmed, it will be my honor to serve as Commissioner of the FDA.

And although I come at a time when we are celebrating the last 100 years, for me, it is — even more importantly — an opportunity to look to the future, to use this moment to focus on the FDA of the future: the FDA we will create for the 21st century. Certainly, if one looks at your agenda — which spans a wide range of FDA issues — it is clear that you are looking ahead, as well. I also know that, although our roles may be very different, we ultimately share the goal of a healthier, safer nation.

And it is in that context of the future that I especially appreciate the opportunity to speak with you this morning, and I would like to focus particularly on innovation in biomedicine, because we are truly at a 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 — and, in fact, of health. It is a future that was, in ways, unimaginable even a few years ago, a future to eliminate the suffering and burden of diseases. It is an opportunity that is within our grasp, an opportunity that we must seize.

But creating that future will require change, which will affect all of us, regardless of our role or job title. Unfortunately, the only human organism that actually likes change is a 6 month old with a dirty diaper. For most of us, change is what we expect in others.

For healthcare and for health, change has been a very slow and incremental process that has been evolutionary more than revolutionary. For thousands of years, medicine was practiced and based on a very macroscopic perspective of disease and understanding of health. Our understandings of disease processes — and even our definitions of them — were based on what we could tell with our five senses.

About a hundred years or so ago, we moved from that macroscopic perspective to a microscopic perspective. For the first time, we could see the cells that made up the tumor or the bugs that were responsible for an infection under a microscope. And that transition was a very radical transformation.

That 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. We have lived in that macroscopic and microscopic world for almost the entire history of healthcare.

But in the middle of 20th century, with the discovery of DNA, another process of transformation began. Biomedical science began a journey of innovation: the journey to unravel the very fundamental mechanisms of life and the underpinning of disease processes, and to unravel them — not at the macroscopic and microscopic level — but at the molecular level.

And 10 years ago, in my opinion, we really crossed the threshold 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.

Based on the new perspectives — of health and of healthcare — that will evolve from the molecular metamorphosis, we are already envisioning a future in which healthcare will be personalized, healthcare will be pre-emptive, and healthcare will be predictive. And I would even add that, with the continuing integration of information technologies and strategies of communication, for the patient, healthcare 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 define new interventions and, in the very process of delivering those interventions to patients, we will begin to understand the biology of human diseases in the human person. And so, delivery becomes, in itself, a platform of discovery.

The path from discovery to delivery has, within its center, the developmental process. All of the fruits of the tremendous explosion in innovation that’s been occurring in biomedical research — which make 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-delivery continuum, we must look to the bridge of development, which must be supported and undergirded by the FDA.

And as we are aware, the bridge must be stronger, if it is to serve our needs in the molecular era. Looking to the future, then, I believe we must envision an FDA that will not only be a science-based regulatory agency, but that will be a science-led facilitating agency, which helps new products come across that bridge of development more rapidly, in much larger volumes, ready to be delivered to patients.

One very important initiative that will significantly advance our vision for the FDA of the 21st century is the Critical Path to Personalized Medicine, which was launched in 2004. I am committed to Critical Path, because it makes it possible for FDA’s regulatory processes to fulfill the goal of becoming science-led, as well as science-based. We will retain all the rigor, all the discipline, and all the precision of regulation, but our efforts will be geared so that things can move faster, rather than slower.

Since its inception, the Critical Path initiative has developed and evolved. It is my commitment to accelerate the pace of that development and to accelerate the implementation of Critical Path. The original report contained a series of recommendations, and we have been in a process of implementing many of those programs and processes. For example, in January, the FDA announced the implementation of the “Exploratory IND”: a mechanism that will allow for a revamping of the earliest of phases of clinical research, so that we can provide opportunities to begin to define and test small doses of medications that will be safe in delivery, but will give us opportunities to understand fundamental mechanisms and biologic process before going on to the larger, traditional Phase-1 to Phase-3 processes.

Last month, Critical Path took another step forward. Together with Secretary Leavitt of the Department of Health and Human Services, we announced concrete, specific steps developed in two years of extensive consultation with stakeholders in the academic and private sectors. The “Critical Path Opportunities List” that contains 76 specific priority projects we are committed to implementing. There are two areas that all stakeholders agreed should be top priorities:

The first is “Biomarker Development,” where we anticipate that a new generation of predictive biomarkers can dramatically improve the efficiency of product development and help identify safety or toxicity issues long before a product is on the market, and even prior to testing in humans.

The second area of focus is “Streamlining Clinical Trials.” In our review, stakeholders from all sectors stressed that both reforming clinical trial design and trial conduct would dramatically improve the efficiency of product development.

Other areas of emphasis in Critical Path will include bioinformatics; moving manufacturing processes into the 21st century; interventions for emerging public health concerns like pandemic flu and bioterorrism; and therapies for high-risk groups, such as adolescent patients.

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.

Out of all of the progress that is coming in this era, one appreciates the fact that viewing diseases from the molecular perspective begins to provide for us an enormous amount of data and information that must be translated into knowledge. In an effort to do that, we must reach out and incorporate other tools of modern technology, in addition to medical technologies the likes of genomics and proteomics and imaging. Most importantly, we must reach out to implement modern tools of information technology across the FDA.

And so, in addition to Critical Path and an FDA task force on pandemic flu, one of my other initiatives is to immediately and aggressively move to the rapid implementation of effective information technology infrastructures that will facilitate and enable the work of the FDA. Science and medicine are moving aggressively in an era of interconnectivity, and the importance of sharing of data and information — whether it happens to occur among agencies that are involved and invested in research or agencies that are essentially a part of the delivery of healthcare systems like CMS—needs to be coordinated and integrated into a much more seamless network and effort.

In working with and collaborating with CMS, I am honored to have a great friend and partner in Mark McClellan. Mark was confirmed by the Senate as commissioner of the FDA at about 10:00 on a Thursday night. The next morning at 9:00, he and I had our first one-hour meeting, in which we discussed the common purpose and the common bond that we both had — he, as commissioner of the FDA and I, as director of the National Cancer Institute, the largest of the agencies at NIH — and we got the chance to appreciate that we were — and are — in the midst of great opportunity. Mark and I also appreciated that neither of us could succeed in our own missions individually or independently; what was essential and critical in this new opportunity was collaboration and cooperation. We must find a way to come together.

Mark and I formed out of that meeting a commitment to create the Interagency Oncology Task Force, which brought NCI and FDA together in a way that we could begin to explore opportunities for closer collaboration and cooperation between the two institutes. We also appreciated that our focus would span the entire continuum of discovery, development, and delivery of these new, great opportunities that were emerging in biomedical research.

We are finding many ways to collaborate and cooperate at FDA. We will continue to work with the National Institutes of Health and the Centers for Medicare and Medicaid Services, the Centers for Disease Control and the Agency for Healthcare Research and Quality, to achieve a more-streamlined continuum across Discovery, Development, and Delivery. We are looking forward to extending and enhancing our collaborations, our cooperation, and our interactions with the private sector. The change process that is focused on our common purpose — to serve patients and people — recognizes that they look to us not simply for the discovery of new genes, not simply for the development of a particular new drug. They look to us for solutions to their problems. Solutions in the molecular era will — and must — be integrated.

All of us who are part of this change process — the changes that are occurring across the continuum of Discovery, Development, and Delivery— in academia, in our healthcare delivery system, within the industry or within government, like the caterpillar, have no choice. Change is inevitable. It is already occurring. The metamorphosis is underway.

But the caterpillar, in its metamorphosis, has no choice in what it will become. It is destined to be a butterfly. We have a choice. The change process will happen, but we have a choice about what the change process will lead to. Together, through the molecular prism, we can look at our notions of healthcare and the healthcare delivery system that we inherited from the macroscopic and microscopic world, and we can decide what we want them to be in the 21st century. By integration and collaboration, we can influence the outcome of our change process.

We must do the right thing, and we must do it in the right way. The FDA is committed to playing its part and integrating and collaborating in a way that, together, we develop solutions, solutions that will assure the health and wellbeing of our patients and of the public we are committed to serve. And it is a great privilege for me to participate in that effort with all of you.

Thank you very much.