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I am pleased to submit the Food and Drug Administration's FY 2004 Performance Plan. The Plan outlines actions we will undertake to ensure the safety and, where applicable, efficacy of FDA-regulated products throughout their entire life cycle - from initial research and development through their ultimate use/ consumption. This Plan will point out the crucial role that FDA plays in improving the health of the Nation. We steward innovative new medical technologies to the market. We monitor the safety of medical products and foods throughout the manufacturing and distribution chain, and we track the use of these products by consumers and use this feedback to reduce risks to the American Public.

FDA will continue to carry out these roles in an environment characterized by both challenges and opportunities. A major and continuing challenge is the prospect of terrorist attacks on the U.S., particularly via our food supply. But additional challenges face the Agency. To name a few: Import shipments of regulated products continue to grow at 10 to 12 percent annually. These products must be carefully monitored to prevent hazards from entering the country.

Another challenge is the occurrence of adverse events and medical errors associated with the use of medical products. According to an Institute of Medicine estimate, nearly 100,000 Americans die each year as a result of medical mishaps. These incidents, many of which could be reduced by FDA interventions, must be addressed. FDA must also be vigilant about the particular safety concerns of special populations, such as children and the elderly. Under provisions of the "Best Pharmaceuticals for Children Act of 2002, FDA is taking action to encourage the availability of accurate dosing, efficacy and safety information regarding the use of medications in children. FDA also recognizes that the cost of drugs can present a potential barrier to patient access to medicine. To help address this situation, FDA has committed to expand efforts to increase availability of generic drugs and support increases in the number of conversions from prescription to over-the-counter drugs. The Agency will continue to take the opportunity to help millions of Americans enjoy the benefits of innovative medical technologies and nutritious, safe foods by making timely science-based decisions to facilitate their entry into the market.

To address the above challenges and opportunities, the Agency has established five strategic goals:

Risk Management - FDA will continue to effectively manage product risks throughout their life cycle- from research and development through use/ consumption. Risk management decisions will be supported by rigorous scientific analysis that weighs, when appropriate, not on the risk-to-benefit profile of the product itself, but also the risk versus the benefit associated with Agency actions.

Strong FDA - FDA will maintain a strong science-based organization to support its risk management responsibilities by: attracting and retaining the most talented scientists; operating a streamlined and cost-effective agency that is optimally organized to support mission-critical activities; and implementing the President's Management Agenda to deliver value to our constituents. A more complete discussion of Agency efforts to link our programs to favorable public health outcomes is included in the 'Outcomes Appendix' to the Performance Plan.

Counterterrorism - FDA will assist in countering the terrorism threat by: 1) preparing for the possibility of attacks on the U.S. population through a strengthened product monitoring infrastructure and emergency preparedness plans; and 2) responding rapidly and appropriately in the event of an actual attack with effective medical countermeasures and product disposal actions.

Consumer Information - FDA will provide information to consumers, health professionals, and other constituencies that will enable them to make prudent decisions regarding the use of FDA-regulated products. A well-informed constituency will raise the likelihood that product risks will be reduced and improved health outcomes will be realized.

Adverse Events and Medical Errors - FDA will contribute to the reduction of adverse events and medical errors through enhanced reporting capability, strengthened problem analysis, and appropriate risk management strategies to address the problems.

In conclusion, I believe that implementation of this Plan, in collaboration with FDA's health and regulatory partners, will help to ensure that Americans will continue to enjoy the safest foods, medicines, and medical devices of any country in the world, and have more rapid access to new and promising therapies. The combination of safe and, when applicable, effective products that have been validated by rigorous risk analysis, and a well-informed constituency that can use these products wisely should lead to substantially improved health outcomes for the Nation.

I thank you for your support of FDA's FY 2004 Performance Plan,

Mark B. McClellan, M.D., Ph.D.

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