Thank you, Dr. McClellan, for that kind introduction. And thank you for all the wonderful work you're doing at FDA.

I want to start by thanking all the FDA scientists here. Whether you work in one of our six FDA centers or the FDA Office of Regulatory Affairs, I thank you. I'm always proud to say that the best employees in the federal government work at the Department of Health and Human Services. And I know all of you at FDA are doing your best every day to maintain and secure the health and safety of every American.

I'm also happy that we have colleagues here from NIH, CDC, and our sister Departments, the Departments of Agriculture and Defense.

Finally, I want to thank all the state and local science officers who traveled to be here, as well as members of industry who are with us today. We also have scientists from many of our nation's finest academic institutions.

My goal at HHS is to do everything I can to ensure that Americans are strong, healthy, and independent. Every time we take a dollar from the taxpayers, we want to be confident that we can use that dollar to promote their health, security, and independence better than they can. That's our solemn responsibility, and one that I take very seriously. And I think if you asked taxpayers what their priorities were in terms of government spending their money, they would agree that making sure their food and medicines and products are safe is critically important. And that's why your work is so critical.

The greatest health care system the world has ever known operates in the United States, and the researchers and other professionals in this room are part of it. But as great as our system is, we know it can be even better. Our vision for American health care builds on our strengths: competition in a free economy. We continue to make extraordinary progress in providing health care to more Americans. Through waiver and state plan amendments granted to states, we have expanded access to health coverage for more than 2.2 million people, and have expanded the range of benefits offered to 6.7 million other Americans.

As Dr. McClellan is always telling me, this is an exciting and rewarding time to be at FDA. The challenges that FDA faces in promoting and protecting the public health are greater than ever, and thanks to the professional dedication, creativity, and expertise of FDA's professional staff, you are meeting those challenges.

Your contributions as FDA review scientists, researchers, policymakers, compliance officers, inspectors, and so many other key functions are integral to the health and safety of the American people.

From what I can see, we need your dedication now more than ever.

The volume and complexity of activities you regulate has been increasing, and is likely to continue increasing: There are more drugs and medical devices available to save and improve lives, and even more to come. There are more diverse food products than ever before - giving consumers more healthy food options. And we are adding to these food choices by importing a larger volume and greater diversity of foods than ever before. There are also broader choices in cosmetics.

As a result, Americans have more opportunities to improve and enjoy their lives.

But at the same time, this complexity makes your job challenging. That's why we must constantly renew our commitment to making sure safe and effective new food and drug products reach consumers in a timely fashion.

You are also responding to heightened threats of terrorism at home, and critical new support roles for our troops abroad. I am sure that your thoughts and prayers, like mine, are with our military personnel, especially those in Iraq.

Their service is protecting us here at home, and I'm proud that HHS is doing all we can to support them.

I just returned from Afghanistan, where I opened a badly-needed hospital, and traveled with a patriotic FDA doctor, Major David Gan, who is serving in Afghanistan with the Army Reserves.

I know we have food inspectors in the room, so I won't tell you what I learned about food safety in Afghanistan. But let me just say, our Department's help is appreciated and there is more to do.

And because a major part of FDA's mandate is patient safety, this agency has worked with partners throughout HHS to recently propose two new rules to prevent medication errors. The first of these proposals will require bar coding on almost all pharmaceuticals and blood products.

This rule would help reduce the number of medication errors by allowing health care professionals to use bar code scanning equipment to verify that the right drug in the right dose is given to the right patient at the right time.

It would also require the use of machine-readable information on blood and blood component container labels to help prevent errors in the use of blood products.

Medication errors are a serious public health problem, but they are also preventable.

Using this bar code technology, we can prevent such errors as: administering the wrong dose of a drug, administering a drug that causes a known allergic reaction in the patient, administering the wrong drug to a patient, or administering the right drug at the wrong time.

The second proposed rule would make significant improvements to the safety reporting requirements for medicines.

FDA has long collected and used information on adverse events to identify ways that drugs can be used more safely, and occasionally remove products from the market. But we can do better - we can get more useful and accurate information faster and more efficiently with the new regulation.

Under the proposed rule, companies would be required to submit all reports they receive of actual and potential medication errors occurring in the United States to the FDA within 15 days.

By expediting FDA's review and response to medication errors, the quick and complete reporting of these facts will improve patient safety and the ability of doctors to prescribe drugs in the best interest of their patients.

Companies would be required to submit all reports they receive of actual and potential medication errors occurring in the United States to the FDA within 15 days.

By expediting FDA's review and response to medication errors, the quick and complete reporting of these facts will improve patient safety and the ability of doctors to prescribe drugs in the best interest of their patients.

For all that improving medical technology can do, it is much less than people can do through their own choices to improve their health.

One of the ways that people can make better choices is by having better information.

That's why Dr. McClellan and his colleagues are working so hard to improve consumer and patient information.

FDA is undertaking many new efforts to help consumers make better-informed decisions. These include better labeling, clearer guidance for direct-to-consumer advertising, and new enforcement initiatives against dietary supplement manufacturers who make health claims without scientific foundation.

Of course, one of your biggest challenges is meeting the FDA's urgent responsibilities to make our nation more secure.

We all know that we have new challenges in protecting our food supply. FDA has long been concerned about "food safety" - focusing on protecting the food supply from what can go wrong.

Now all of us at HHS worry about food security - protecting our nation's food supply from deliberate attack.

Our colleagues at CDC and DHS are working to prepare responses to bioterror attacks through Project Bioshield.

And you all know that there is also the potential for agents of bioterrorism such as anthrax and botulinum toxin to be used to contaminate our food supply.

Especially at a time of heightened national alert, the security of our food from terrorist attack is a real concern. In meeting these new food security challenges, HHS is improving the safety of our food supply as well.

In the past year, the FDA completed a threat assessment of different categories of food, determining the most serious risks of intentional contamination during various stages of food production and distribution.

HHS has also participated with the Department of Agriculture, the White House Homeland Security Council, and now the new Department of Homeland Security, in numerous counterterrorism exercises to evaluate our emergency response capabilities in simulated food borne outbreak scenarios.

In addition, HHS has reviewed food security and rapid response and recovery procedures with industry groups and trade associations.

The results of those studies are informing our planning and implementation related to food security.

There's significant financial support for this work. FDA drew on last year's special appropriation of $151 million to hire more than 800 new employees, 655 who are focused on food safety activities in the field.

As a result of FDA's aggressive hiring and training program, these new employees are on the job now helping to make the food supply more secure.

And just last month HHS announced a set of new food security measures as part of Operation Liberty Shield.

Operation Liberty Shield is a comprehensive, multi-agency national plan designed to increase protections for America's citizens and infrastructure while maintaining the free flow of goods and people across our border with minimal disruption to our economy and way of life.

The Department of Health and Human Services has many critical roles in Operation Liberty Shield.

For example, FDA published common-sense food guidance documents on food security that are relevant to every food production company - from the smallest mom-and-pop operations and county fairs to the largest food producers.

Also as part of Operation Liberty Shield, FDA is increasing food inspections and sampling at food production facilities and at our borders.

FDA will undertake further efforts to work with the food industry to carry out investigations and audits of domestic and imported food to make sure the measures lead to the greatest benefits for food security without imposing unnecessary costs or regulatory burdens on food production, processing, and distribution.

FDA has also been engaged in an accelerated focus on helping to develop and make available better countermeasures for biological, chemical, and radiological attacks.

In the last two months alone, the FDA has taken major steps to make available effective treatments for certain nerve gases and radiologic agents. FDA has also worked to enhance our nation's stockpiles of vaccines and treatments for smallpox and other possible agents of biowarfare.

Unfortunately, there is limited research into the application of medical approaches to counterterrorism.

For example, the currently available antitoxin to botulism is based on a technology available when the FDA came into existence in 1906. This is a useful and needed treatment, but there's strong reason to believe that new mission-critical technology can produce antidotes and vaccines that are even safer and more effective than what's available to us now.

Research and development into new countermeasures has been slow, largely because there is no financial incentive. Many companies know that the development of medical products is an uncertain process, and they are used to taking risks knowing they might fail.

But they want to know that if they succeed, there's the certainty of a reasonable financial reward. When it comes to countermeasures, there are plenty of risks, and few clear rewards.

Without significant financial rewards for effective, high-value new treatments, with no surety of payments because reimbursement from the only major purchaser (the government) is based on the pressures of the appropriations process and not the value of the innovation, we end up in a situation where the incentives for developing better treatments are inadequate, and where the potential value of modern medical technology is not fully realized.

This is why President Bush has proposed Project Bioshield, a set of initiatives that has attracted bipartisan support. It includes new procurement authorities to provide a certainty of payment in advance for the delivery of effective new products.

By creating conditions for a market that is reasonably predictable and consistent over time, the government will set the stage for the private sector to make the investments and problem-solving efforts required to develop more effective, next-generation countermeasures.

We expect more antidotes and vaccines to flow out of Bioshield, and I know from talking with Dr. McClellan that FDA scientists are ready to help facilitate their development and to make sure the best available treatments can be used effectively in an emergency.

We must all work to make sure the latest innovations in medical technology and in food production provide the greatest public health good to the greatest number of people. As Secretary of this great department, I am committed to working with all of you to make sure that you can get the job done.

Protecting and improving public health provides daily opportunities for excellence and creativity.

I want to thank everyone at FDA for your dedication to the mission. We all need to work together to fulfill this mission under some challenging new circumstances.

Those of you who work at FDA, as well as all the other scientists here today, are in the right profession at the right time to make a real difference in the health of all people, today and in the future.

I'm looking forward to continuing to work with all of you on these great challenges.

Thanks for being here, and have a great forum.

Last Revised: May 8, 2003

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