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FDA Commissioner Confirmation Statement

Statement of

Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner of Food and Drugs

before

the Senate Committee on Health, Education, Labor and Pensions

March 17, 2005

Mr. Chairman and members of the Committee, I am Dr. Lester M. Crawford, D.V.M., Ph.D., Acting Commissioner of the Food and Drug Administration (FDA or the Agency). I would like to thank the Committee for inviting me here today. I am honored to be here, and I appreciate the opportunity to tell you about myself and share ideas for how we can strengthen and advance the nation’s public health.

FDA is the nation's principal consumer protection agency. The Agency impacts the lives of all Americans every day. We ensure the safety and efficacy of the medicines they consume. We regulate 80 percent of the food Americans eat. FDA-regulated products account for approximately 20 cents out of every dollar in the economy. American consumers rely on FDA to protect and advance the nation’s public health while people around the world share the view that the Agency upholds the gold standard in terms of public health protection.

I have had the extraordinary opportunity over the course of my career to serve four different tenures at FDA. This is the second time I have served as Acting Commissioner of the Agency. I previously served as FDA Deputy Commissioner from 2002 to 2004 and as Director of FDA’s Center for Veterinary Medicine from 1982 to 1985. Prior to that, I held several different positions – including Director – in the former FDA Bureau of Veterinary Medicine in the 1970s.

My career outside of FDA has likewise been dedicated to advancing the public health. I served as Administrator of the Food Safety and Inspection Service at the U.S. Department of Agriculture from 1987 to 1991. Prior to that, I was Chair of the Department of Physiology-Pharmacology at the University of Georgia, and held the position of Associate Dean for several different offices at the University of Georgia College of Veterinary Medicine.

More recently, from 1997-2002, I was Director of the Center for Food and Nutrition Policy at Georgetown University and at Virginia Tech, where it moved in 2001. I also served as Executive Director of the Association of American Veterinary Medical Colleges from 1993 to 1997.

I am a member of various professional societies. I am a Member of the National Academy of Sciences Institute of Medicine, a Fellow of the Royal Society of Medicine (UK), and a Fellow of the International Society of Food Science and Technology. In 1984, I was inducted into the French Academy of Veterinary Medicine. In 1991, I received the Wooldridge Award, the British Veterinary Associations highest award. Additionally, I have been an advisor to the World Health Organization of the United Nations for much of my career.

In terms of academic training, I received my Doctor of Veterinary Medicine (D.V.M.) from Auburn University, my PhD in pharmacology from the University of Georgia, and an Honorary Doctorate (M.D.V.) from Budapest University.

Throughout my diverse career, I have had the unique opportunity to contribute to a number of groundbreaking public health initiatives. For example, I played major roles in the development of mandatory nutrition labeling, the formation of the World Trade Organization, and the control of chemical and microbiological contaminants of food. In recent years at FDA, I have led efforts to combat the obesity epidemic, counter terrorist threats through new food security regulations, and revitalize the regulation of biomedical and food industries through the development of current good manufacturing practices. I also introduced FDA’s “Critical Path” initiative, a new cutting-edge approach to advancing medical innovation that seeks to bridge the so-called gap between bench and bedside.

Going forward, as Commissioner of the Food and Drug Administration, if confirmed, I look forward to the opportunity to build on these initiatives and help America reach new levels of public health protection and innovation.

This is a critical time for the nation’s health. We face exciting opportunities from new cross-cutting science and biomedical innovation, but at the same time we are confronted with profound challenges of every shape and size – emerging diseases, product safety concerns, the threat of bioterrorism, and much, much more.

Our success – and the nation’s health – are continually challenged by these emerging threats, changes in technology, and global market forces. At the same time, FDA’s responsibilities are growing in scope and complexity. To overcome these growing challenges, and to truly capitalize on the boundless opportunities presented by modern science, we need a vision for the future – a vision for a 21st century FDA.

I would like to tell you briefly about my vision for FDA and my priorities for the time ahead. The FDA of today understands, perhaps better than ever, the need for both protecting and advancing the public health, and we are focusing on new and better ways to perform our core mission.

My vision for the future of FDA is one of transformation. Internally at FDA, we’re transforming from domestic-focused, paper-based processes, employing yesterday’s technologies, to global, electronic-data driven decisions that apply the latest science. And we’re transforming our culture to one of transparency, collaboration, and cutting-edge thinking.

We’re going to tap into new technologies and new ways of thinking, and build upon collaborations with a broad network of partners—public and private, U.S. and international. By capitalizing on 21st century information technology and regulatory process innovation, we can leverage public investment in FDA to yield an even greater level of public health protection, and a more efficient and predictable critical path to innovation. By adopting a quality systems approach in all of our operations, we will increase productivity and promote better health outcomes.

In particular, I am committed to addressing existing concerns regarding post-market safety of FDA-regulated products, both in medical products and food, respectively. I remain focused on bioterrorism and on minimizing the threat of terrorist attack both through heightened food security and through the development of new medical countermeasures. As we confront 21st century challenges, 21st century solutions are key; that is why “innovation” will be at the center of everything FDA does in the time ahead. I look forward to helping lead the way as we enter a new era of individualized medicine and e-health. Finally, we need to continue to do more to empower our citizens with better health information about the foods they eat, the medicines they use, and the other health products they consume. Under my leadership, I will see to it that FDA continues to provide all Americans with the tools they need to make informed choices about their health, so that they can live longer, healthier, and happier lives.

These issues impact us all. I know that the members of this committee are genuinely focused on doing all you can to address these public health challenges and capitalize on our public health opportunities. I am truly honored to have worked with you in the past to advance FDA’s public health mission, and I look forward to continuing to work with each and every one of you to better protect and advance the public health in the time ahead.

Thank you.