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FDA Seeks to Invest in Foodborne Illness Prevention


The U.S. Food and Drug Administration (FDA) is requesting a budget of $4.3 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2012 budget. This would represent a 33% increase over the FDA enacted budget for FY 2010.

Margaret A. Hamburg, M.D., commissioner of food and drugs justifies this request during this tough economic time by stating, “FDA protects and promotes the health of all Americans through every stage of life. The breadth of this mandate means that FDA responsibilities continue to grow. The new budget contains new resources so that FDA can fulfill its growing responsibilities to the American public.”

The FDA 2012 budget proposes four critical initiatives and increases.

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The FDA desires $324 million for transforming the Food Safety and Nutrition Initiative. Included in this initiative would be the implementation of the landmark Food Safety Modernization Act, allowing the FDA to establish a prevention-focused food safety system resulting in a more reliable food safety system to protect American consumers. FDA will also empower Americans to make more healthful food choices through menu and vending machine labeling.

The FDA is requesting $70 million for the Advancing Medical Countermeasures Initiative (pdf file) to ensure that the FDA can support the development of medical countermeasures (MCMs) to respond to serious national security threats – chemical, biological, radiological and nuclear threats, as well as naturally emerging diseases such as pandemic influenza. To improve public health response, FDA will also modernize the legal, regulatory and policy framework that governs development and availability of MCMs.

The FDA is requesting $124 million for the Protecting Patients Initiative (pdf file). With this increase, FDA will develop a pathway for approving biosimilars, which are biological drugs shown to be highly similar to, and without clinically meaningful differences with, an FDA-approved reference biological product. Such biosimilars may also be shown to be interchangeable with the FDA-approved reference biological product. These biosimilars offer the potential of significant savings for government and private sector healthcare systems that provide care to millions of Americans. The Protecting Patients Initiative also strengthens FDA efforts to modernize and improve safety throughout the supply chain of medical products, and it contains other resources to assure the safety of medical products.

The FDA is requesting $49 million for the Regulatory Science and Facilities Initiative (pdf file). This request will allow FDA to strengthen its core regulatory scientific capacity that support all elements of the FDA mission. This initiative will help harness advances in science and technology to modernize and streamline the regulatory pathway and improve the review and approval process for products relying on new and emerging technologies that offer promising new opportunities to diagnose, treat, cure and prevent disease.

Food and Drug Administration Press Release, Feb 14, 2011