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Leading an organization is like navigating a white-water raft, according to FDA Commissioner Andrew C. von Eschenbach, M.D. "Both tasks involve dealing with day-to-day crises or getting through the toughest rapids on the river," he says. "At the same time, we must chart a strategic course that allows us to fulfill our mission over the long haul to reach our chosen destination."
In support of the agency's mission to promote and protect the public health, FDA's Strategic Plan focuses on four strategic goals:
FDA is committed to strengthening the scientific foundation of its regulatory mission. This involves bringing in new scientific fellows through the FDA Fellowship Program, an initiative that will build and maintain the agency's workforce for the 21st century. Specific actions, such as enhancing FDA's Advisory Committees and applying consistent methods of scientific analysis, will help cultivate a culture that promotes transparency, effective teamwork, and mutual respect. These steps will also ensure integrity and accountability in regulatory decision-making.
FDA is also taking significant steps to enhance partnerships with other organizations and bolster its base of operations. It takes modernized facilities and information systems to support efficient operations. One example is the consolidation of FDA headquarters at the White Oak site in Silver Spring, Md. The new FDA campus includes new laboratories and up-to-date facilities to support scientific computing and electronic document management.
The safety of drugs and other medical products regulated by FDA continues to be a priority. The agency is working to strengthen the science that supports product safety—from upgrading methods of benefit and risk analysis, to improving information systems used to detect and communicate safety problems. FDA has established a Risk Communication Advisory Committee to better understand the needs and priorities of the public, and has launched an electronic newsletter on post-market drug safety findings.
In addition to giving consumers better access to clear and timely risk-benefit information for medical products, FDA also has formulated strategic objectives for informing consumers about better nutrition and foodborne illness prevention. Through three core elements—prevention, intervention, and response—the agency's comprehensive Food Protection Plan offers food protection along the entire production chain.
One avenue for increasing access to safe and effective medical products is FDA's Critical Path Initiative. This effort spurs modernization of the scientific process—the Critical Path—through which FDA-regulated products are developed, evaluated, and manufactured. Improving the Critical Path will help move medical discoveries from the laboratory to consumers more efficiently while maintaining FDA's standards for safety and effectiveness.
Another example is an agency initiative to better understand drug-induced liver injury, one of the most common and severe problems associated with prescription drugs. Through scientific collaborations, researchers will be able to better identify early signs of liver toxicity so that unsafe drugs can be detected early.
As for increasing access to safe and nutritious new food products, FDA is exploring new scientific approaches to better understand how the unique attributes of individuals affect the safety of food ingredients, nutrients, and dietary supplements.
FDA is dedicated to preventing safety problems by modernizing science-based standards and tools that ensure the manufacturing, processing, and distribution of high-quality products. Developing standards and guidance for industry to promote best practices will help prevent problems in the supply chain.
Detecting safety problems earlier and better targeting interventions are critical for preventing harm to consumers. With emphasis on more advanced risk-based targeting of inspections and faster analysis methods, FDA is working to respond more quickly and effectively to emerging safety problems. The agency is also improving the way it coordinates responses with other government agencies and communicates with the public during incidents.
FDA has celebrated more than 100 years of service as a science-based and science-led regulatory agency that provides global leadership in promoting and protecting public health.
"The agency's strategic plan is about trust," says Dr. von Eschenbach. "It is about establishing trust by doing the right thing, and by doing it in the right way.
All of FDA's strategic goals and objectives aim to build a future that holds promise for healthier and safer lives for all Americans."
FDA Strategic Action Plan
www.fda.gov/ope/stratplan07/stratplan07.htm
Date Posted: February 29, 2008
