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Our Mission and Scope of Responsibilities

As part of the Department of Health and Human Services, FDA has broad responsibilities for promoting and protecting the health of American consumers.

FDA's Mission

The public trusts FDA to ensure that:

1. Foods are safe, wholesome, and properly labeled
2. Drugs for both humans and animals, and vaccines for humans, are safe and effective
3. Blood used for transfusions is safe and in adequate supply
4. Medical devices, from scalpels to MRI scans, are safe and effective
5. Transplanted tissues are safe and free of contamination
6. Equipment that uses radiant energy, such as X-ray machines and microwave ovens, is safe
7. Cosmetics are safe and properly labeled

Although FDA's mission statement clearly outlines these general responsibilities, it does not convey the tremendous scope of activity that we oversee. Decisions made by FDA affect every American every day. To illustrate:

• Last year consumers spent almost $1.5 trillion - more than 20 percent of their money on products that we regulate.
• We judge the safety and often the efficacy of an expanding scientific revolution. Public and private entities invest an estimated $50 billion annually in biomedical research and technology.
• We assure the compliance of the Nation's manufacturing and processing with FDA regulations: FDA is a 10,000-person agency, and is responsible for monitoring over 100,000 U.S. firms that manufacture or process FDA regulated products.
• We also monitor the safety of 8 million import shipments that enter this country each year.

To successfully accomplish its mission, FDA leadership has identified five strategic goals. Each goal reinforces the importance of risk management as the Agency's primary tool to address the Nation's health and safety concerns. Progress towards these goals will be made using both FDA's base resources and those additional resources requested in the FY 2004 Budget request.

Risk management, to FDA, means that we use all means available to minimize health or safety risks facing the American people by:

1. Correctly assessing the risks based on scientific understanding and rigorous risk analysis;
2. Establishing risk priorities based on this analysis; and,
3. Effectively managing risks with the appropriate intervention - beginning with the most critical risks.

Our Strategic Goals:

• Risk Management - FDA will minimize risk to U.S. consumers throughout the product life cycle - from research and development through production, distribution and use. Rigorous science-based assessment of hazards and thorough risk analysis will provide the foundation for effective risk management decisions. Because of the Agency's timely science-based decisions, millions of Americans will have access to the medicines and medical devices they need, and can be assured that these products are safe and effective.
• A Strong FDA - FDA will maximize return on its human capital by recruiting and adequately compensating the highest caliber scientists and health professionals to carry out its mission. It will also support the President's Management Agenda to create a streamlined, citizen-centered government agency. Key strategies to achieve this goal include:
  • De-layering the bureaucracy; restructuring Agency functions so that they are more supportive of mission-critical activities;
  • Reconfiguring information technology systems to more effectively support decision making at all levels in the Agency;
  • Outsourcing traditional government functions where cost efficiencies can be realized;
  • Capitalizing on e-government efficiencies;
  • Strengthening financial management systems; and,
  • Establishing accountability to the U.S. taxpayer by linking Agency resources to performance and public health outcomes.

FDA leadership is currently in the process of exploring possible outcome indicators that could be linked to Agency program efforts, as well as data sources that would provide valid and reliable measures of these indicators. This progress is described in Appendix B of the Performance Plan entitled "Progress Toward Developing Outcome Measures."

• Counterterrorism -FDA will prepare for the possibility of terrorist attacks on the U.S. population, and respond rapidly and appropriately in the event of an actual attack. This will require:
  • Detection, deterrence and interdiction of potentially dangerous foods and medical products overseas, at our borders and throughout domestic commerce;
  • Having adequate supplies of safe and effective medical products to protect or treat victims of an attack;
  • Sharpen FDA's emergency preparedness and response plan that will protect the American Public and maintain the internal security of FDA; and,
  • Minimizing threats from radiological sources.
• Consumer Information - FDA will engage in a variety of activities designed to provide the best available information to consumers, patients and health professionals to make them full participants in managing risks associated with FDA-regulated products.
• Adverse Events and Medical Errors - FDA will accomplish this health care goal by collaborating to establish a comprehensive reporting capability with the cooperation of the health care community; analyzing and quantifying the risks revealed in adverse event reports and other data sources; and taking appropriate actions to prevent future harm.

To effectively carry out these priorities the Agency will adhere to fundamental principles that frame all of its actions and which will lead to more effective public health results. These principles support:

• Using rigorous science and risk analysis to make accurate and timely decisions regarding the safety of products and processes;
• Thinking and acting in a global context - Since the products FDA regulates are produced and marketed worldwide, the Agency's risk management strategies must also be approached from a global perspective;
• Making decisions that consider the total product life cycle - FDA must use both premarket and postmarket product experience/ data in making regulatory decisions. Agency practices and regulations must be focused on keeping products safe and effective throughout their entire life cycle; and,
• Working with partners in all sectors to strengthen the Agency's prevention efforts. FDA cannot accomplish its vital public health mission without stakeholder collaboration.

The following page summarizes FDA's strategic goals, the desired outcomes of these goals, and key performance targets for FY 2004. Table 2 summarizes the specific results that will be achieved as a direct result of each FY 2004 Increase request.

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