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FDA | FDA Centennial
Inaugural International Summit
“The Challenges of Regulation
In the World of Molecular Medicine”
HHS Auditorium
Washington, DC
Andrew C. von Eschenbach
Opening Remarks
This text contains Dr. von Eschenbach prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.
It is a great pleasure and an honor for me to welcome you all here today. I am especially honored that the leaders of medical product regulatory agencies from 19 countries have taken the time to travel very long distances to participate, and to recognize FDA's 100th birthday. FDA is pleased to convene this inaugural international summit as a part of its centennial anniversary to focus on HEALTH DIPLOMACY and Global Regulatory Challenges. As national leaders in our respective countries, one of the most important issues that we face for the 21st century is the health of our people. Providing health care is a major economic burden for all our countries
We are together here as leaders of our respective regulatory agencies from many different countries, speaking many different languages, and facing many different challenges. Here in Washington D.C. and around the world there are meetings such as this where world leaders come together to discuss their differences and conflicts, and struggle to understand what divides us. They struggle to find answers as to how to deal with the suffering and death that result from the violence and hate that comes from those divisions and conflicts.
They, and we, struggle as leaders to find that one quest that could unite us and make us one world. Some time ago at such a discussion, one person offered that the single most important event -- the single most profound and important thing that would unite all people and create one world -- would be to discover life on another planet. Life on another planet would unite us in a common quest as earthlings to face that common challenge.
Perhaps this is a cynical commentary on human nature -- but there is a core of truth that an enemy of all humankind would compel us to put all our differences aside and join as one world in one quest.
My friends and colleagues, we don't need to look to another planet to encounter an enemy of humankind -- That enemy is right here among us and within us. That enemy is disease.
Acute and chronic diseases like cancer, HIV/AIDS, Alzheimer's, malaria, avian influenza, tuberculosis, and diabetes. Disease that is indiscriminate -- spares no human life, young or old, man or woman, and cares nothing about geographic borders. No part of the world is safe from disease.
Disease has made us one world. We now have one quest -- the quest to eradicate and prevent disease
As heads of health and medical product regulatory agencies we have the responsibility to come together in meetings such as this one, not to define our differences, but to recognize and share strengths, to work together to identify and realize what we MUST do and HOW we can do it, to defeat our common enemy -- disease.
We come together now, at this very special moment in time when we have an extraordinary opportunity: We come together at a time of the most radical transformation to ever occur in the history of medicine -- the beginni9ng of the era of molecular medicine.
We now have the opportunity to completely shift the paradigm of health, the opportunity to move beyond inadequate treatment of disease to prevention and eradication. This establishes the opportunity, for the first time, to move from trying to fix what is broken to preserving what is good.
We have new opportunities and new hope. Thanks to the work of researches, scientists, clinicians and people like Lee Hartwell, we are able to begin to understand disease. To understand the genetic and molecular mechanisms that are responsible for disease. This understanding is rapidly leading to the development of new interventions.
100 years ago when the FDA was established in the U.S. -- science and technology's quest was to understand the nature of matter and energy and that progress transformed civilization. Today, as we gather here, science and technology's quest has been to understand the fundamental nature of life and disease. We now have the potential to once again transform civilization. We have already approved products and medicines that have established the proof of principle that hope is real for a new future of health and health care. A future of personalized, predictive, preemptive and participatory medicine
Today we come together as heads of medical product regulatory agencies with the opportunity to collaboratively build a bridge, not a barrier -- A bridge that will span the gap between all that promise of science and technology and the delivery of the interventions that can eradicate disease for all of our people. But the bridge must be morphed to accommodate the new science and technology.
Along with the great opportunities that are presented by this new era of molecular medicine come great challenges. We must be prepared to move the potential avalanche of new products into the hands of the healthcare providers and the people themselves.
My hope is that we can do this together. One enemy -- one quest -- one world.
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