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Mark B. McClellan, M.D., Ph.D. - Farm Journal Forum

This text contains Dr. McClellan's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Remarks
by
Mark B. McClellan, M.D., Ph.D.
Commissioner of Food and Drugs
for
Farm Journal Forum
December 3, 2002

Good evening, and thank you, Ms. Taylor, for the generous introduction. I am honored to address this gathering and share this platform with Dr. Murano, who bears with us at the FDA the responsibility for the nation's food. Her expertise in food safety is a great asset to our government's efforts to improve the public health.

And I am highly pleased to meet some of the people who have made our country the world's most prolific, innovative and safest food producer. I'm looking forward to working with you to promote and protect the public health.

This is the second time since I was sworn in -- less than three weeks ago -- that I am addressing a group involved in food production. The reason is obvious: the way we regulate food can directly affect the lives and health of all 288 million Americans. And the challenges facing our food programs have never been greater. But with help from our constituents, with innovative regulatory thinking, and with support from Congress, I am optimistic that FDA will meet these challenges.

The day after I was sworn in as the Commissioner, I attended a groundbreaking for a new facility in the future FDA White Oak campus that, to me, symbolizes what I hope lies ahead for FDA: a modern, scientifically up-to-date, responsive, and efficient agency that is able to provide better protection for our consumers and more effectively promotes their health in the face of new challenges.

I see four major steps as critical for achieving this goal. I want to talk about them first, and then will discuss some of the new issues we're dealing with in the food area.

First, to strengthen our agency's ability to meet the challenges of food and drug regulation in the 21st century, we must rely on the best science. We must use creative thinking and science-based risk management to increase public health benefits while minimizing the public health risks. And we must do all we can to ease the regulatory burden. This is a must for the industries in our purview as well as for the FDA if it is to keep pace with an economy that generates new products at a staggering rate.

And the food industry is incredibly creative. The average supermarket now stocks more than 30,500 different items. To reach for another example in FDA's regulatory purview, in 1982, our pharmacists filled prescriptions for 7,300 FDA-approved drugs. Today, they dispense more than 11,700 prescription drugs, and the approval of many of them required a much more complex and sophisticated evaluation by the FDA than used to be the case earlier.

This wealth and variety of new products is a boon for our consumers, because it helps them improve their health and better enjoy their lives. But the speed of innovation also presents our agency with new questions to be resolved and novel guidelines and regulations to be developed. To meet this formidable task, we've been given new resources and new authorities; but there is no substitute for new ideas. Creativity and innovation must be the FDA's hallmarks in the 21st century.

A second critical task of our agency is to reduce adverse health events, a large number of which is preventable. These health problems that need not have occurred are far too common; they extract an enormous toll in human suffering; and they carry a staggering economic tab to boot. Medical errors are estimated to account for 40,000 - 100,000 deaths per year in hospitals alone. Misuse of pharmaceuticals and other FDA-regulated products is annually associated with thousands of deaths and millions of hospital admissions. In 2000, the economic cost of drug-associated errors alone was estimated to be more than $75 billion a year.

Another type of often-preventable adverse event, foodborne infection, is also a serious public health problem. According to a 1999 survey by the Centers for Disease Control and Prevention (CDC), foodborne diseases cause annually 76 million cases of illness, 325,000 hospitalizations, 5,000 deaths, and an economic damage of up to $23 billion. In addition, inadvertently consumed food allergens result in thousands of avoidable emergency room visits. If we can find creative ways to prevent even a fraction of these preventable events, think about the benefits to our health, our health care system, and our economy.

To address this urgent problem, I intend to expand the use of new information technology (IT) to improve our understanding of what causes preventable adverse events. In medical care, it is conceivable to develop of an electronic network that would provide automatic updates on adverse events and the circumstances that may have contributed to their occurrence. Such information network could also enable the FDA to disseminate automatically updated, relevant information on medical labels and warnings, and thereby help prevent the adverse events from happening again. Our agency is already conducting pilot IT programs in our centers for medical devices, drugs, and biologics.

A third top FDA priority is to help consumers get reliable, accurate, and relevant information about the FDA-regulated products. For all that the new medical technologies in the pipeline can accomplish, they cannot match the public health benefits of sound lifestyle and dietary choices that individuals can make themselves. Americans know this, and they increasingly want to learn more what they can do to keep or improve their health. At the FDA, we are responding to this demand is several ways. To mention a couple of familiar examples, our agency has introduced nutrition labeling that encourages shoppers to select foods low in saturated and "trans" fats, and high in fiber, and we require the distribution of a leaflet with relevant drug information with each new filled prescription - and we are working to improve it.

But consumers today expect us to do still more, and we must not disappoint them. We must disseminate up-to-date and reliable scientific information on the health effects of foods and nutritional supplements; and we must make sure that the ads and claims for medical products, foods, and dietary supplements are truthful and not misleading. Moreover, we must make use of all means to get this information to consumers in a way that would most benefit their health.

There is no example more persuasive of the need for innovative approaches than the national epidemic of obesity. This is a very serious, and growing, public health problem. According to a CDC survey, in 1985 fewer than 14 percent of Americans were overweight. Today, more than a third of our adult population is obese, 64 percent of U.S. adults are obese or overweight, and 15 percent of 12-19 year-olds are overweight. The health consequences include greater incidence of diabetes, stroke, coronary artery disease, cardiovascular disease, and high blood pressure -- and that's not the complete list. The economic costs of diseases linked with excess weight run into hundreds of billions of dollars each year.

Although the FDA has approved drugs for curbing appetite and breaking down dietary fat, their use usually does not result in a weight loss greater than 10 percent. There is no better remedy for excessive weight than healthy lifestyle choices -- and to make them, consumers need better information on how their diet affects their health.

Our agency has been helping to provide such information through educational articles, guidelines and press releases, and we have proposed to improve the food label by including in it the amount of "trans" fatty acids and a footnote cautioning that their intake should be "as low as possible." In addition, we plan to conduct studies that could help improve the label's usefulness for consumers. One of these projects probes the label's impact on the shopper's choice of food; the second is focused on the value consumers attach to the label's information; the third explores their perception of the health claims on dietary supplements; and the fourth study measures consumers' reaction to claims and disclaimers on conventional food and dietary supplements.

But FDA cannot achieve the goal of a well-informed public through labeling requirements and agency educational campaigns alone. We also need to find better ways to encorage food producers to compete on the basis of scientifically sound nutritional claims. As a recent study by the Federal Trade Commission noted, ads with scientifically-based health claims can have substantial positive effects on the choices of consumers. Here is one area where we may be able to get more useful nutritional information to consumers.

In addition to these concerns, since September 2001, the FDA has assumed a critical new responsibility on the nation's front lines against terrorism. Helping protect our homeland is a privilege and our paramount public health job, and we are doing all we can to deserve the trust placed in our agency. Our centers for pharmaceutical products are working to adapt their approval processes to the unique challenges of developing safer and more effective treatments for anthrax, smallpox, plague and other potential agents of bioterrorism. Our center for medical devices is supporting the development of methods for detecting biological agents with bioterrorism potential, and for radiological decontamination. These new tools are needed now, and we are doing our best to help bring them to the nation's defense as quickly as possible.

And we have no responsibility more important and challenging than to protect the safety and security of the United States food supply. As you know, 80 percent of foods are within the FDA's purview, and as you also know, the problem of food safety did not originate in September of last year. During the last decade, rising incidence of food contamination with Listeria, Salmonella and other pathogens -- combined with our more diverse and aging population, greater preference for prepared foods, and rapidly growing food imports -- sharply increased foodborne outbreaks that produced the dismal CDC statistics I mentioned.

As many of you also know, the FDA countered these developments by joining the CDC, the U.S. Department of Agriculture (USDA) and state health agencies in creating several systems for the detection and identification of food hazards; by developing new rules for safer food production and processing; by intensifying its research on food contaminants; and by helping educate the public about proper food handling and good hygiene in the kitchen.

These programs have brought results: earlier this year, the CDC reported a 21-percent decline in illnesses from the four most common foodborne pathogens, and a food safety survey conducted in 2001 reported substantial improvement in the way our consumers handle food. But the terrorist attacks last year highlighted new potential risks of deliberate food contamination. To counter this unprecedented menace requires new thinking on how to better safeguard our food.

Much work toward this goal has already been done. In the fall of last year, for example, our agency initiated a scientific assessment of the vulnerability of various categories of food to intentional contamination. The appraisal explored the severity of the public health and economic impact of a potential bioterrorist attack on our food supply, and the likelihood of such an event to take place. The FDA has developed also two guidances -- one each for domestic food producers and for food importers -- on how to protect their products against tampering.

But much work remains ahead of us. In particular, the FDA is taking part in two multi-agency efforts to give our bioterrorism counter-measures greater scientific depth and geographic distribution. Thanks to the leadership of Undersecretary Murano, we've joined the Food Safety and Inspection Service and several other federal agencies in laying the groundwork for PrepNet, a network focused on the prevention of -- and response to -- the introduction of microbial, chemical, radiological or physical contaminants into the food supply. And we are developing plans for a cooperative Field Laboratory Response Network that will upgrade our ability to quickly recognize and identify a terrorist attack on food.

Our efforts to improve food security have received strong support from the President, the Secretary of Health and Human Services, and Congress. Thanks to a supplemental appropriation of $153 million, we have been able to hire more than 800 new employees whose job will be to keep watch on imports and whatever other avenues our enemies might try to use to contaminate our food or tamper with other regulated products. But it is important to keep in mind that reducing risks to food security requires more than hiring inspectors. Even with the great expansion of FDA's presence in the nation's ports of entry, we will be able to inspect only a fraction of the 5.1 million food shipments that will be imported this year.

And that's why we need to find innovative ways to make our foods more secure without adding unnecessary costs. With this goal in mind, the President last June signed bipartisan legislation designed to give the FDA greater control over food in general, and imported food in particular. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 does not generally affect farms or restaurants, but it does address practically every firm, domestic and foreign, that's involved in getting food processed, packaged, and put on the market.

The law's cutting edge are four provisions whose requirements we are now in the process of fleshing out in soon-to-be-issued proposed regulations. This project is on the fast track, and I am committed to issuing the final rules by their statutory deadline. At the same time, I will allow as much time as possible for comments on the proposals, for their refinement, and for the necessary planning.

One of these regulations will require all facilities that manufacture, process, pack or hold food for consumption in the U.S. to register with the FDA by mid-December, 2003.

A second regulation will require importers to provide the FDA with a prior notice of food shipments that includes information about the shipment's contents and origin, as well as the anticipated port of entry.

A third regulation will obligate food businesses to maintain records to enable us to determine where the food came from and who was its subsequent recipient, so that we can quickly trace any food contamination back to the source.

The fourth regulation authorizes the FDA to order the detention of food on the basis of credible evidence or information that it poses a serious health threat to humans or animals.

In finalizing and implementing these regulations, we intend to work with all affected parties to find the most effective, and least costly, ways of addressing significant risks to the security of our food supply. I look forward to your comments and suggestions as we tackle this critical new challenge next year.

There are several other issues in the food arena that are very much at the center of our attention. One of them is ensuring the safety of genetically modified feed and foods, and strengthening the public's confidence in these new products. Genetically engineered crops are increasingly common: field tests of new plants in the U.S. have increased more than eight-fold in the last eight years, and bioengineered crops are now grown on 130 million acres world-wide. The public's concern about these food products is also strong, as was recently illustrated by the media coverage of the commingling of small amounts of bioengineered corn with soybeans that had been intended for consumption.

This incident, which involved corn modified to express pharmaceutical proteins, was handled quickly and effectively. When it was discovered that some leaves and stalks of the experimental corn had been mixed with 500,000 bushels of soybeans, the FDA, USDA, and the State of Nebraska made sure that the entire lot was secured in a warehouse, and ProdiGene, the firm that had modified the corn, agreed to buy back and destroy the entire affected lot. None of it entered the human or animal food supply.

The pharmaceutical material in the ProdiGene corn was being studied under an Investigational New Drug application, a process by which the FDA makes sure that the safety and effectiveness of each new drug is tested in properly designed and conducted trials. But this is only one of several ways in which we are ensuring the safety of genetically engineered plants.

In the last ten years, the FDA has evaluated more than 50 new varieties of bioengineered plants that had been submitted to our agency by their developers. The basis of this cooperation was an FDA policy, supported by the industry, of voluntary consultation before the biorengineered products are marketed. To help expand similar protections beyond the U.S. borders, FDA's scientists have worked with the Codex Alimentarius Commission of the World Health Organization/Food and Agriculture Organization (WHO/FAO) to draft guidelines for the assessment of safety of foods derived from rDNA plants. And to get the best outside advice on food biotechnology issues, the FDA has established a new Food Biotechnology Subcommittee of its Food Advisory Committee.

Currently, as part of a project organized by the White House Office of Science and Technology Policy, we are preparing draft guidance for industry to provide early food safety evaluations for new proteins in bioengineered crops for food or feed. If developers establish that these new proteins are safe for consumption -- meaning, that they do not raise questions about their allergenicity and toxicity -- then the foods containing low levels of these innovative plants could be marketed.

We're also conscious of the importance of the public's perception about the safety of bioengineered food. Ever since the first of these products were developed 10 years ago, the FDA has been carefully evaluating them by applying rigorous scientific standards, and we are confident that all of these bioengineered foods and feed are as safe as their conventional counterparts. Our position has been that special product labeling therefore would only be required to disclose when the bioengineered product has undergone a significant change, such as modification of the nutritional value. We will remain vigilant in addressing concerns about genetically modified food and feed.

Next, I want to bring you up-to-date on the FDA's progress in addressing an issue that has stirred great interest among food scientists. I am referring to the studies released earlier this year that show that baked, fried or roasted foods rich in carbohydrates -- including such dietary staples as bread -- contain acrylamide, which, at high doses, is a known animal carcinogen. In soft bread, the reported levels of acrilamide range from 30 micrograms to 162 micrograms per kilogram, and in potato chips, to mention another example, the range is from 1.4 micrograms to 100 micrograms per ounce.

Acrylamide is well known to manufacturers who use it for water treatment and production of dies and plastics, but it is largely a terra incognita for food scientists. There were epidemiological studies conducted in the past that did not show increased cancer risk in people, but the studies were limited in scope, and did not include ingestion of the acrylamide in food.

Given the key role of carbohydrates in our diet, it's been incumbent on our scientific community to subject acrylamide to a close scrutiny. Some of the questions that need to be answered are, for example, is it genotoxic? How is it formed? What is its level of exposure in the general population? What is its bioavailability in food? And what are the biomarkers of acrylamide exposure?

I am glad to report that these questions are being vigorously tackled by many scientists in government, industry and academia. The WHO/FAO has created a special network for sharing the emerging data - and new information is coming in fast.

The FDA is making a significant contribution to this research. Our agency has developed a method for measuring levels of acrylamide in foods, and used it so far on about 300 types of products, including cereals, breads, and chips. We're developing an understanding how acrylamide is formed, which is very important for finding ways how to keep it out of food; and we are probing the chemical's toxicity. This week, we will report these and other findings to a subcommittee of our Food Advisory Committee.

Finally, I want to give you an update on chronic wasting disease (CWD), which has been found in several states in farmed and wild deer and elk. CWD is a very serious public health issue: it is one of the transmissible spongiform encephalopathies, caused by abnormal proteins called prions, that include the Mad Cow's disease in cattle; scrapie in sheep and goats; and classical and variant Creutzfeldt-Jacob disease in humans. There is no vaccine or treatment for these diseases, and there are no validated diagnostic tests for them that can be used in live people or animals. Moreover there is no scientific evidence that CWD does or does not pose the same kind of threat to humans or farm animals as the other transmissible prion-related diseases.

The FDA is collaborating with other federal agencies in studies of the risk of CWD in the food supply, and the transmissibility of CWD to humans. In addition, in the last three weeks, we have informed state officials that the FDA will not permit material from CWD-positive animals, or animals at high risk for CWD, to be used as an ingredient in feed for any animal species. This measure is similar to the precautions the FDA has taken to protect our livestock from the Mad Cow's disease. We have clarified that the ban applies only to new material from deer and elk in certain parts of Colorado, Wyoming, and Wisconsin where there is an increased risk of CWD. We've also indicated that the feed previously made from the now-banned materials does not need to be recalled. The best news is that so far, despite a careful multi-agency monitoring program, we have no report that CWD has infected humans or other animals except for deer and elk.

I have described several FDA food safety programs that are high on our agenda, but I need to add that although important, these projects are only a small part of entire spectrum of our food concerns. In addition to the programs I've talked about, we're preparing good manufacturing practices for dietary supplements; trying to improve the food labeling with respect to allergens; doubling our food inspections at the ports of entry; and we are stepping up our enforcement against potentially harmful nutritional supplements. We even test typical home-cooked meals for residues of pesticides and other contaminants.

I am confident of our agency's ability to rise to the many new challenges we face. However, I cannot emphasize enough that our continued vigilance and innovation in promoting the public health would not be possible without the cooperation, dedication and skill of our farmers, food processors, food distributors, and millions of others who are involved in getting safe and wholesome food products from the field to the consumers' tables.

I thank you for your commitment to our shared cause of bringing to American homes safe, varied and plentiful food, and I am looking forward to our continued cooperation to promote and protect the health of our people.