David Kessler, MD, vice chancellor for medical affairs and dean of the UCSF School of Medicine testified on Tuesday, May 1, before the House Oversight and Investigations Committee hearing on the future of the Food and Drug Administration. Kessler was FDA Commissioner from 1990 to 1997.
Text of Remarks
Mr. Chairman and members of the committee, thank you for the opportunity to participate in today's hearing. I am Dr. David Kessler, Dean of the School of Medicine at the University of California, San Francisco.
The opportunity and challenge this Congress has before it now, to equip the Food and Drug
Administration (FDA) to meet the public health challenges of the 21st century, are as pivotal as those that Congress faced in 1938 and 1962 when it gave the Agency the fundamental responsibility of ensuring drug safety and efficacy.
We are seeing a confluence of factors - chronic under-funding, a lack of enforcement authority, severely outdated scientific and regulatory frameworks - that are creating a lack of confidence in the FDA and its many dedicated people. At the same time, there are considerable challenges the Agency must be able to address if it is to remain the world's standard for public health protection.
These include globalization of markets, particularly in food and drugs, and the imminent and profound shift toward a new era in medicine in which treatments are geared to individuals rather than mass markets.
I want to focus this morning on food safety.
Simply put, our food safety system is broken.
We have no structure for preventing food-borne illness in this country. The reality is that there is currently no mandate, no leadership, no resources, nor scientific research base for prevention of food safety problems.
There is no one in the executive branch with the clout and Authority to prevent food-borne illness.
FDA can react to outbreaks but the emphasis needs to be on preventing outbreaks before they happen.
Over the past 20 years, there has been robust debate about the FDA's role in drug approval and safety. This focus on drugs also has been reflected in Agency funding and management attention.
Now, it is time, indeed overdue, to address the same attention and concern to the Agency's food safety mission.
In 1938 when the statute was written, people were not thinking about food safety in terms of global markets and worldwide supply and distribution networks.
Spending weeks or months tracing back cases of food-borne illness to their origin, although important, is too much like chasing the horse after it has left the barn and too often with devastating results in illness and death.
Congress and the Administration should act urgently to strengthen FDA by meeting its resources needs and by unifying and elevating food safety leadership within FDA and the Department of Health and Human Services (HHS).
Food safety cannot compete with drug or device safety for resources and leadership.
Food safety cannot be delegated to second-tier management within the agency, and the fact is that food is a second-tier priority within the FDA. In addition, the current structure is fragmented in FDA. Responsibilities for food are spread across the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and the Office of Regulatory Affairs.
There must be a clear recognition within HHS that food safety is an essential part of protecting the public health. And it cannot be housed in the Department of Agriculture, because the Secretary of Agriculture does not speak for public health.
We need a commissioner of foods at FDA who is responsible and accountable for all that FDA does on food safety, in headquarters and the field, and who reports directly to the Secretary.
Our focus today needs to be on prevention, not just reaction, if we are to have any hope of averting a future failure in the food safety system:
FDA must have the scientific capability to do the research and to develop the right processes and controls;
Producers and suppliers must be required to take steps to protect their link in the food chain;
And, the Agency must have the authority to hold producers and suppliers accountable for the failure to establish the necessary protections.
Mr. Chairman, I appreciate your long-standing interest in these issues and your willingness to devote your time and energy to finding a solution to the challenges confronting the Agency. I offer to you whatever help I can provide as you work toward strengthening the ability of the FDA and the federal government to continue to protect the health of the American people.
Hearing Examines FDA's Vital Mission and Challenges for the Future
Committee on Oversight and Government Reform, US House of Representatives, May 1, 2007
Food Safety Put on New Czar's Plate at FDA
Los Angeles Times
, May 2, 2007