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Remarks as Delivered at FDA CentennialI am delighted to be at the Food and Drug Administration. I was just thinking, as I sat next to Dr. McClellan, that my first official responsibility with respect to the Food and Drug Administration actually came while I was at the EPA, where Dr. McClellan and I had to hammer out an important agreement on the difference between albacore and light chunk tuna. But it succeeded. And I was pleased about it. I have a friend, a woman who recently turned 50, and she told me she was going to deal with that by celebrating every single day of the month. I thought that was a good strategy. I can see that when you turn 100 it�s okay to celebrate virtually every day of the year. Today, of course, we're celebrating the centennial of the gathering of when Teddy Roosevelt signed the Pure Food and Drugs Act, and we created this agency. Theodore Roosevelt once declared that it's true of a nation, as well as individuals that the greatest doer must also be the greatest dreamer. He was both. Roosevelt's vision was vital in creating the water link between the Atlantic Ocean and the Pacific Ocean, the Panama Canal. About three weeks ago I visited the Panama canal for the first time and saw that remarkable feat. They literally carved a canal through a jungle. And in doing so that vision not only created a monumental engineering feat, it also changed the world in a fundamental way. The world became smaller. The economy became global, and it has done nothing but increase in its effect since that time. So, being a dreamer and a doer is an important combination. I recently had a chance to review the history of this agency, and life of Dr. Harvey Wiley, the father of the Pure Food and Drugs Act. It turns out that he and Teddy Roosevelt were a kind of pair in doing this. I'm told they really didn't get along all that well. Both men could see that the nation would be made stronger, and its citizens would obviously be protected, if its foods were safe and its medicines weren't tainted. They shared the confidence in the power of science to transform people's lives for the better. And they shared a vision of a healthier and a more hopeful America. Their vision, and the dedicated efforts of FDA's countless civil servants who followed in their footsteps, have shaped this nation in profound and powerful ways. We depend on the FDA. We depend on it every day. It clearly has to be considered one of the great brands, if you will, in America, in the world. It's the gold standard. A brand really is nothing more than a promise. It's an expression of trust. And Americans place it, place their trust in the Food and Drug Administration. When we gather our families at night for dinner we rely on the Food and Drug Administration and that promise, that trust, we know that our food is safe. When you're alone at night with a sick child administering some medicine, you do so with the confidence, with the trust, with the promise of that brand, knowing that someone, some good team of scientists, have thought through as carefully as possible that this is a safe thing to do with someone that you love. Safer foods and better medicine have made a striking difference in the longer, healthier lives of Americans. In Roosevelt's day, men didn't expect to pass their 47th birthday. Women did not expect to see 49. But today, they're living almost three decades longer. Americans rarely die of epidemic diseases, like tuberculosis, that routinely killed thousands of people in Roosevelt's era. Thanks to what the FDA has done in being able to provide an approval process and certification of drugs like penicillin and other antibiotics, life in America and across the world has changed. FDA personnel have been active in protecting Americans from lead and arsenic and other things that are used in pesticides around the world. After the FDA set standards for enriched foods, nutritional deficiency diseases like scurvy, rickets, and others virtually vanished from the United States. FDA standards for folic acid have dramatically reduced the number of babies that have been born with spina bifida and other kinds of birth defects. FDA personnel have brought us significant gains in science and given us great gifts of art. The progress of the past century has been simply phenomenal. But I believe that the great leaps of our public health can only be surpassed by the next ones. Today I believe we're taking small steps toward a new era of medicine, one in which treatments are going to be more focused on prevention, and be more predictable and personalized. I was shown an advertisement today in a large national paper. It was a great, big full-page ad showing two pills. One said "Pill." The other one said "Special Pill," and had an asterisk by it. And then at the bottom of the page, under �Special Pill" the ad said, "Made according to your DNA." Well, that's where we're headed: A transformation that's going to touch literally every person. It will be a day in which medicines will, in fact, be made according to our own DNA. In the upcoming era of patient-centered medicine, new treatments will be developed at a faster pace, and of a larger scale and in more economical ways. New medical devices will provide individualized solutions for medical conditions. Integrated information networks will connect health care systems and drug developers on different continents and will allow a doctor to be able to send a prescription directly from the office to the pharmacy before the person leaves the parking lot of the clinic. People will be engaged as active participants in their own health care. They'll be acting with better information about their health, and they�ll be having more interaction with their health care providers. There will be more partnerships between government researchers that will enable the faster identification of drug targets. And there will need to be a 21st century regulatory process that will be built to handle it. Today, there�s a huge gap between the discovery of new compounds and the delivery of new medicines. Many medicines and medical devices treat symptoms, but they fail to touch the roots of the disorder. In the future, we will see new medical products coming to the market on a far more frequent basis. Many of them will target specific disease processes or will be aimed at pre-empting disease that have been detected by new diagnostic tests. Drug delivery systems and medical devices will change rapidly as well, taking a lot of novel forms and increasing the effectiveness of health care. Our regulatory system is not yet prepared to deal with those changes. We have to reinvent the regulatory process, enabling and not inhibiting medical progress, and we will. The FDA in the next century will be at the forefront of changes, just like you have been in the last century. FDA personnel will be playing a leading role in the transformation of the critical path to medical product development, finding better ways to rapidly develop and improve safety in the treatments that we all look forward to, treatments that are highly personalized, that will come at lower cost and with a greater degree of success. That transformation of the critical path will be a larger part of the transformation toward personalized medicine, one that will improve the health of this nation in ways that Roosevelt and Wiley could have never imagined. I want you to know that I believe that we have the power to do just that. Every person who serves at the FDA is taking part in a great effort of making people's lives safer and better. Few experiences could be more satisfying. Few opportunities could be more profound. So, as we now begin this celebration of the anniversary, the centennial, let's all stop for just a moment and pledge to follow the footsteps of those who have made this agency great and this nation great. Let's all promise anew to go forward in the spirit of Roosevelt and Wiley and what they did 100 years ago, dreaming and doing, protecting health and promoting the welfare, furthering the fondest dreams and the highest aspirations, of the American people. Today, I close by bringing a greeting from the President of the United States, who, in a special letter for this occasion, indicated his appreciation to the men and women of FDA for promoting excellence and the integrity of our food and drug industry. He closes his letter by saying, "You have earned the trust and respect of the American people, and your efforts have helped build a healthier future for all." Let that second century of our future begin. Thank you. Last revised: July 7, 2006 |
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