Good morning.
I am here today to discuss the state of the Food and Drug Administration, less than two months after I joined the agency. That may sound like a tall order, but FDA and I are no strangers. I first joined the agency's Bureau of Veterinary Medicine in 1975, as a visiting scientist on a one-year sabbatical. I came back in 1978 as the Bureau's director, and stayed for two years. I then returned in 1982, again as the director of the Bureau.

In 1984 the Bureau became the Center for Veterinary Medicine, and I left it, as the Center's director, a year later. All told, this is my fourth tour with the agency. Obviously, there is some chemistry at work that keeps bringing me back.

Let me start my report by telling you how I find the FDA of 2002 different from the FDA I left in the 1985. In some aspects, not a great deal. It's bigger, but not much. It is still meticulous about its science, insistent on integrity, careful in decision-making. Still comparing its budget to NIH's. Even some of my colleagues from my time as the CVM director are still there.

But there is one aspect in which I find today's FDA different from the FDA I knew a generation ago, and that's a new sense of challenge and responsibility. I don't think there has ever been a period after the passage of the Food and Drug Act in 1906 when many people questioned the role of the federal government in the protection of the public health. But if there were any such doubts, they certainly vanished in the morning of last September 11.

On that day, all Americans realized that the safety and security of their daily lives suddenly could not be taken for granted, and they turned to the federal government for protection. And when they did that, many of their demands and expectations were addressed to the FDA.

To be propelled to the front lines of defenses against terrorism is a development that brings heavy obligations, but it is also evidence of significant trust and support by the public, Congress, the Department of Health and Human Services, and the White House. It is an implied strong endorsement not likely to be lost on any organization or person. And it hasn't been lost on the FDA.

The agency I re-joined at the end of February mainly differs from the one I knew in the 1980s in its acute awareness of the new dimension of its mission, of its centrality for our nation's well-being, and of the commitment of the agency's employees to see that mission succesfully carried out. Formally, our job has not substantially changed. We are still responsible for the safety, or safety and effectiveness, of the same categories of products worth one trillion dollars' of consumers' money.

Our priorities and perspectives, however, have been transformed. And this is the subject of my talk. What I want to do today is take a brief look at what we regard as FDA's most important obligations and opportunities in the wake of last September, and show how we are meeting them.

Quite obviously, FDA's Job One is to do its utmost to contribute to the nation's defense against terrorism. Counter-terrorism is not a new function for the agency. The FDA was assigned in the late 1990s responsibility for two defensive measures: preventing willful contamination of all regulated goods; and increasing the availability of medical products to prevent or treat injuries caused by biological, chemical, or nuclear agents.

As part of this mission, FDA has been advising industry and consumers on food safety and security since 1998, and in August 2000 it approved the antibiotic Cipro for use in patients exposed to inhalational anthrax. But the attacks on the World Trade Towers and the Pentagon escalated these responsibilities to a new order of magnitude.

FDA began discharging them on September 11. The agency's foremost concern on that somber morning was how to increase the availability of blood for transfusions: with the air transportation system shut down, the critical component of the blood assurance program was suddenly missing.

By the end of the day, the FDA issued a statement that authorized several measures to facilitate emergency collections, transportation and release of blood for transfusion -- blood that, tragically, was not needed because most of the victims of the assaults perished.

That was the start of intensive activity that we still pursue today, and will continue advancing into the future. By the end of 2001, our agency provided regulatory guidance for a government contract on new smallpox vaccine,and eased potential medication shortage for the victims of the mailed anthrax powder by clarifying that the antibiotics doxycycline and penicillin G procaine are effective for the treatment of all forms of anthrax infections. Our agency also inspected renovated facilities for the production of anthrax vaccine, which had been halted in 1998. The vaccine was authorized for distribution in January, 2002.

Since then, the FDA has continued to work closely with the pharmaceutical industry, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and other agencies to improve the availability of medications and medical devices in case of another terrorist attack.

But our greatest concern has been the safety of food, a universally consumed product that's potentially susceptible to contamination by terrorists. Eighty percent of the national food supply -- all but meat, poultry, and some egg products -- is within FDA's purview. After September 11, protection of this vital resource became the agency's foremost challenge.

As it happened, food safety had been a special FDA priority since the start of the 1990s, when the public health community became concerned about the rise in foodborne disease. That development had nothing to do with terrorism. One of the reasons for the alarming incidence of foodborne outbreaks was the fast-growing American appetite for year-around fresh produce, and a variety of foods from all over the world. This resulted in a phenomenal upsurge of imports:in 1985, we imported fewer than one million food shipments; by last year, the number was 4.5 million.

This prolification of food sources and long transport of many perishable products multiplied the chances of contamination. In addition, our consumers were increasingly eating out, which meant that their food was handled by many more people than it would be at home; there was an emergence of new foodborne pathogens; and we had an aging population and a lot of people with compromised immune systems, all whom were especially susceptible to foodborne disease.

All of these developments made foodborne disease a major public health menace causing, according to the CDC, about 76 million cases of disease, 325,000 hospitalizations, and 5,000 deaths a year. The economic cost was estimated at $6.9 billion a year.

The FDA, together with other federal, state and local health authorities, had to respond. They jointly created new surveillance systems, better prevention programs, faster outbreak response, a food safety campaign, and better coordinated and focused research and risk assessment programs.

These improved protections against accidental contamination were in place and keeping our food supply the world's safest on September 11; and since then, they have become the basis of the still more demanding system of protections that are being put in place to keep food secure from intentional contamination by terrorists.

At FDA, we are addressing the threat of food terrorism with a three-point strategy consisting of anticipation, deterrence, and response:

• In order to better anticipate a potential threat, we are gathering information about our food assets and their viability as carriers of possible contaminants. In addition, we're very interested in whatever the intelligence community can tell us about the capability and intent of potential aggressors who could target our food supply.
  
  
• To strengthen our capacity for deterrence, we have developed together with industry two security guidances: one for domestic food producers, processors, transporters, and retailers, and the other one for importers, brokers and others involved in importing products to this country. Both guidances outline measures that these firms can take to reduce the potential risk of a terrorist attack on food under their control.
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  Our most important deterrence measures, however, consist of strengthening the FDA's capacity for inspections, laboratory analysis, and compliance and enforcement. Congress has authorized us to spend for this purpose $151 million, $97 million of which we're using to improve the safety and security of food. We are now in the process of hiring 655 new employees for our field operations, 600 of whom will reinforce our food program. At least two-thirds of this total -- 400 -- will be primarily assigned to monitor imports.

They will enable our agency to conduct 24,000 import inspections a year, nearly double the present total, and that number will double again once the additional staff is trained and on the job.

Our plans also include the hiring of 30 specialists who will perform risk assessments and develop rapid methods for the detection of pathogens in various types of products.

• In addition, the Department of Health and Human Services has proposed a bill that would strengthen FDA's response potential by improving our ability to rapidly trace back and remove from distribution imported food that's contaminated. Congress is currently considering two bills that would boost the FDA's ability to vigorously counter a terrorist attempt.

Preventing existing hazards is not the only challenge that terrorism has added to our agenda. We're also preparing to deal with public health issues that are likely to emerge as we improve our defenses against terrorism. For example, we anticipate a great increase in the use of radiation-emitting devices that are currently used to make sure that people visiting prison facilities or boarding commercial aircraft do not carry concealed weapons.

At present, the risk from these screening devices is low, but that will not necessarily be the case as their numbers and detection capacity increase. For example, a new security system for the detection of contraband inside a person requires 100 times higher doses of radiation than is used routinely.

It is not appropriate to use this system in situations where the lower-dose devices are sufficient. Individuals should be exposed to ionizing radiation only when a clear and compelling benefit outweighs the associated risks. New standards, recommendations for use and policies are needed, and we're working to fill the need.

Since November 1999, the FDA has led an effort with the American National Standards Institute to develop a consensus standard assuring radiation safety for personal security systems that emit low-level radiation. A draft standard was completed in January, and we expect that the final standard will be published within the next few weeks. We've also assessed the capability of existing instrumentation and calibration systems for reliable measurement of radiation exposure. We need new instruments to accurately measure radiation leakage from security devices that use x-rays.

As could be expected, the heightened focus on security has increased also concerns about other public health hazards, some of which could be vulnerable to hostile intervention. We are therefore increasing our vigilance and actions on several fronts:

• We're examining our measures to protect our country's livestock from BSE -- bovine spongiform encephalopathy, or "mad cow disease" -- which is believed to cause an uncurable human disease called variant Creutzfeldt-Jakob Disease, or vCJD. There is no evidence of BSE in the United States, at least in part thanks to an FDA rule prohibiting the use of most mammalian tissues in feed for cattle and other ruminants.

But this regulation is now five years old, and we believe it's time to take another look at it to make sure it provides us with the best protection possible.

• Another important development we're confronting is the growing antimicrobial resistance in humans caused in part by the use of antimicrobials in animals, particularly in livestock and poultry. We've addressed this hazard with several vigorous measures, including a proposed change in the way the FDA approves these drugs for use in livestock and poultry.

Currently, we are also developing a general guidance on microbiological safety that will present a single plan incorporating various strategies for assuring that animal antimicrobials do not pose a hazard for humans.

• The safety of dietary supplements is another challenge on which we are intensively focused. These are products that are used by more than 158 million Americans whose main concern, as we hear at public meetings, is whether the supplements are safe. We're working to make sure that they are by implementing a ten-year program that will place the safety, composition and labeling of dietary supplements on a firm scientific and legal basis. One early step we plan to take toward this goal is the publication of a proposed rule for good manufacturing practices in the production of dietary supplements.
  
  
• Finally, the Department of Health and Human Services just a few weeks ago clarified another safety issue, which has to do with drugs used by children. The Department has reiterated its commitment to implement all provisions of the Best Pharmaceuticals for Children Act as quickly as possible, including its provisions for funding pediatric studies of important drugs that do not benefit from other incentives.

We will also be reviewing and soliciting public comment on our so-called "pediatric rule" to determine which parts of it should be retained to cover potential gaps in the existing legislation, and which requirements -- if any --are unnecessary and should be eliminated.

Speaking of clinical trials brings me to another set of issues involving the safety of FDA-regulated products -- issues that challenge our ability to pursue our public health mission abroad.

As most of you know, the multinationalization of the regulated industry and the globalization of trade that have taken place over the past 40 years have prompted our agency to negotiate cross-border agreements whose purpose is to ensure that imported products comply with U. S. public health standards.

By and large we've been successful in these efforts, and we now have more than 60 agreements with foreign countries whose governments are cooperating with us. But as globalization advances into new areas, we sometime have to undertake abroad new tasks that call for exceptional initiative and effort.

One example is the extraordinary increase in the number of foreign researchers conducting clinical trials of drugs developed for the American market. In 1990, the FDA had in its data base 271 foreign researchers performing this function in 28 countries. By the end of the decade the number of such researchers grew to 4,458 -- a 16-fold increase -- and the number of countries where they conduct the clinical trials increased to 79.

Now, some of these countries subscribe to the guidelines developed by the International Conference on Harmonization, which ensure the quality and address many fundamental aspects of clinical studies. In these countries, there are provisions for the protection of trial participants, and for the integrity of the data about the products' safety and effectiveness. But some foreign governments do not subscribe to these standards, and that can raise doubts about the quality and safety of clinical trials conducted in their jurisdiction.

This is a situation that the FDA cannot tolerate. We cannot be uncertain about patient protection, which is a basic human right, and we cannot have doubts about the integrity of the research data we use for product review and approval. Without ethical trials that produce verifiable, quality data, there is a real concern for patient safety, and no level field for competition.

And so we are presented with the question of how to ensure that all drugs, regardless where tested, meet the U.S. standards when they are submitted for FDA's review. We are working hard to find the answers. We are cooperating with other U.S. agencies, the World Health Organization, and our foreign counterparts to build in-country capacity for the oversight of these studies wherever they take place. We're also looking at our own criteria for accepting the results of these foreign trials, to make sure they serve our public health mission.

I could spend a great deal of time discussing our challenges, both at home and abroad. I could dwell on the intricacies of our implementation of the Mutual Recognition Agreement with the European Union, an agreement that could save both our and European Union's resources by sparing us the need to inspect European plants that produce drugs and medical devices for our market, and vice versa.

And I could talk about the impact on FDA's workload of new technologies that require the agency's expertise and oversight. These products, which are now coming out of research pipelines, range from genetically manipulated food and animals to products that combine medications and devices; nanotechnology; robotics; and cell and gene therapies, to mention just a few.

But I don't want to leave you with the impression that the tragic violence of last September has so multiplied our agency's challenges that we are about to be overwhelmed. Nothing could be more wrong. For one thing, we don't fear challenges -- we see them as opportunities to serve our public better. For another, the FDA has not earned the widespread support I mentioned earlier by failing its mission.

As an institution, we have a solid, 96 year-old record of protecting and promoting America's public health, whose success is reflected in the rising longevity and high quality of life in our country.

As a person who has watched FDA's performance for almost 30 years, I am confident that our agency will overcome the challenges that lie ahead of us. We have the scientific expertise, the experience, the resources and the commitment to meet the demands and expectations of our time in the best FDA tradition:by strengthening the shield of protections that help keep our nation healthy, vigorous and thriving.

FDAWebsite Management Staff
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