FDA Unveils Five-Part Strategic Action Plan to "Protect and Advance America's Health"

WASHINGTON, D.C. -- In a comprehensive five-part strategic action plan titled "Protecting and Advancing America's Health: A Strategic Action Plan for the 21st Century," the Food and Drug Administration (FDA) today outlined how it is taking new steps to protect and advance public health for America. The plan, which sets some new specific actions and performance measures directly related to achieving FDA's public health mission, establishes a framework for achieving five broad priority goals for FDA. The action plan is not an exhaustive list of the agency's many ongoing regulatory activities; rather, it highlights some of the specific steps that FDA is taking to address new challenges facing the agency.

"Today, we need a strong and effective FDA more than ever. This strategic action plan is our coordinated effort to respond to some of the most challenging threats and opportunities for public health that we have ever faced," said FDA Commissioner Mark B. McClellan, MD, PhD. "I'm proud to say that our action plan represents the best ideas and creative thinking of our professional staff at a critical time for our agency and the nation. The FDA's five priority goals outlined in the strategic plan also flow directly from the public health priorities established by President George W. Bush and Secretary of Health and Human Services Tommy G. Thompson. These broad strategic directions represent our conclusions about how to maximize the public health impact of every FDA dollar and of our greatest resource, the thousands of dedicated professionals at the FDA."

Efficient, Science-Based Risk Management. FDA has long led the world in applying the principles of risk management - assessing public health risks, analyzing methods for reducing them, and taking appropriate action. Today, with the expanding complexity of the agency's food and medical challenges and the need to reduce the health risks facing the public at the lowest cost to society, efficient risk management is more important than ever.

The agency's approach to efficient risk management requires the use of the most current biomedical, statistical, managerial, and economic science. By employing principles and technologies that can reduce avoidable delays and cost in product approvals, by overhauling and updating the way medical products are manufactured, by implementing more effective strategies for food imports and food safety, and by implementing an enforcement strategy that combines clear communications to industry backed up by effective civil and criminal enforcement, FDA will achieve quicker access to safe and effective new products, and reduced public health risks without unnecessary costs.

Patient and Consumer Safety. Too many American's suffer from preventable adverse events related to medical products, dietary supplements, and foods, resulting in many billions of dollars in avoidable medical costs each year.

Consequently, FDA is enhancing its "post-market" monitoring, communication, and regulatory activities. In addition, one of the most promising new ways the FDA can improve its system for reporting safety problems is to have direct and secure access to relevant modern electronic health information. By supplementing the current passive reporting systems and partnering with healthcare providers and other government agencies, FDA will develop more innovative and effective information on the risks associated with FDA-regulated products. Through steps such as bar coding medications and implementing new, 21st-century methods for communicating with health professionals to reduce adverse events, FDA will help speed the implementation of safer systems for medical care and foods.

Better Informed Consumers. Informed consumers represent the nation's greatest public health asset, because the choices that people make every day can have a great impact on their own health and the health of the nation. Providing consumers with all the tools they need to make better-informed choices about how to use their health care dollars, and protecting them from misleading information that wastes their money and effort, is of utmost importance to the agency.

FDA is undertaking major new efforts to ensure consumers have the most up-to-date, truthful information on the benefits and risks of FDA regulated products. In this arena, FDA fulfills two complementary roles: ensuring that the information sponsors provide about products is accurate and allows for their safe use, and communicating directly with the public concerning benefits and risks of products FDA regulates.

FDA's strategic plan calls for the agency to learn more about how to communicate with consumers more effectively about risks and benefits. The goal is a well-informed public, empowered to make better choices to improve their health.

Counterterrorism. As the nation's leading agency in protecting the security of the nation's food, FDA is improving its capability to assess and respond effectively to risks associated with threats to harm Americans through the food they eat. As FDA recently reported, the Agency is working with other government agencies and the private sector to develop and implement a comprehensive strategy to protect the food supply from attack. These include additional staff for food safety field activities, greater import presence at our nation's borders, threat assessments, and additional money for food security research. FDA's medical product centers are also working harder and more creatively than ever to speed the availability of the next generation of safer, more effective countermeasures to protect Americans against biological, chemical, nuclear, and radiological agents of terrorism.

A Strong FDA. FDA's continued ability to carry out its mission of protecting and advancing America's health, rests squarely on its most important resource: a talented and dedicated staff. "Only with a strong workforce, armed with the tools and resources needed to get the job done, will FDA be able do the job Americans deserve and expect," said McClellan. FDA is taking additional steps to improve retention and training, and is implementing new activities to augment the agency's capabilities through use of outside experts and collaborations. FDA is also implementing steps toward completing the consolidation of much of its work force in a new campus in White Oak, Md.

"The strategic action plan we are announcing today will set the tone and provide direction for our public health work in the months and years to come," added McClellan. "We are laying out key strategic goals, so that all FDA constituents will know what to expect from us, so they will be able to evaluate progress we are making toward those public health goals, and so they can all participate with us in the process."

Source: FDA