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Through specially targeted initiatives, FDA intensifies efforts to ensure the safety of America’s food supply, and to make safe, effective, and affordable medical products available to the public, whether imported or made in the USA.
On May 22, 2008, FDA launched the Sentinel Initiative with the ultimate goal of creating and implementing the Sentinel System--a national, integrated, electronic system for monitoring medical product safety.
The Sentinel System will enable FDA to query multiple, existing data sources, such as electronic health record systems and medical claims databases, for information about medical products. The system will enable FDA to query data sources at remote locations, consistent with strong privacy and security safeguards. Data sources will continue to be maintained by their owners.
This historic new system will strengthen FDA's ability to monitor the performance of a product throughout its entire life cycle, thus enhancing the protection and promotion of public health. Such a system could also ultimately facilitate data mining and other research-related activities.
As envisioned, the Sentinel System can be achieved with minimal transfer of data, using tools and processes that will ensure the protection of patient information. Sentinel Initiative Web site.
On November 6, 2007 the Interagency Working Group on Import Safety presented to President Bush its Action Plan , which contains short- and long-term recommendations for continuing to improve the safety of imports entering the United States. The Action Plan contains 14 broad recommendations and 50 action steps that provide a road map for better protecting American consumers and enhancing the safety of the increasing volume of imports entering the United States. The Action Plan is the product of extensive coordination among Federal agencies, months of hands-on information-gathering, and feedback and suggestions from the private sector and the public. The Working Group issued a Strategic Framework on September 10, 2007 Protecting Americans Every Step of the Way: A strategic framework for continual improvement in import safety.
Visit FDA’s Action Plan for Import Safety Web site.
American consumers enjoy one of the safest food supplies in the world; however, we know it can be made even safer. FDA regulates $417 billion worth of domestic food and $49 billion worth of imported food each year—everything we eat except for meat, poultry, and some egg products, which are regulated by the U.S. Department of Agriculture.
FDA has developed a comprehensive Food Protection Plan to address the changes in food sources, production, and consumption that we face in today's world. Building upon and improving an already sound food safety protection capability, the new plan presents a robust strategy to protect the nation's food supply from both unintentional contamination and deliberate attack. FDA's Food Protection Plan builds in prevention first, then intervention, and finally, response. This new strategy will help ensure that Americans continue to benefit from one of the safest food supplies in the world. Food Protection Plan Web site.
This year more than $2 trillion worth of products are expected to be imported into the United States from around the world. FDA works closely with counterpart agencies in many other countries to help assure that FDA-regulated products coming into the United States meet the standards of safety and quality that Americans expect. These products include food and animal feed, human and animal drugs, cosmetics, medical devices, vaccines and other biological products, and radiation-emitting goods.
FDA and its Chinese counterparts are developing agreements to increase cooperation and information sharing between the U.S. and Chinese governments. These agreements are aimed at protecting the public health and providing safe products to U.S. consumers. Visit the China Partnerships Web site.
On October 4, 2007, FDA launched the Generic Initiative for Value and Efficiency, or GIVE. The initiative will use existing resources to help FDA modernize and streamline the generic drug approval process.
GIVE aims to increase the number and variety of generic drug products available. Having more generic-drug options means more cost-savings to consumers, as generic drugs cost about 30 percent to 80 percent less than brand name drugs.
Generic drugs are identical to their brand-name counterparts in dosage form, safety, strength, route of administration, quality, performance, and intended use. Generics also go through a rigorous scientific review to ensure both safety and effectiveness. Visit the Generic Initiative for Value and Efficiency Web site.
On September 27, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007, with (from left to right) HHS Secretary Michael Leavitt, FDA Commissioner Andrew von Eschenbach, and Rep. Joe Barton of Texas in the Oval Office. This new law represents a very significant addition to FDA authority. Among the many components of the law, the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA) have been reauthorized and expanded. These programs will ensure that FDA staff have the additional resources needed to conduct the complex and comprehensive reviews necessary to new drugs and devices.
Two other important laws were reauthorized: the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). Both of these are designed to encourage more research into, and more development of, treatments for children.
Overall, this new law will provide significant benefits for those who develop medical products, and for those who use them. Visit the Law Strengthens FDA Web site.