FDA requests $4.3 billion to protect and promote health of Americans as part of FY 2012 budget

The U.S. Food and Drug Administration 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 — a 33 percent increase over the FDA enacted budget for FY 2010. The FY 2012 request covers the period of Oct. 1, 2011, through Sept. 30, 2012.  

"FDA protects and promotes the health of all Americans through every stage of life," said Margaret A. Hamburg, M.D., commissioner of food and drugs. "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:

• Transforming Food Safety and Nutrition ($324 million) Initiative: With this increase, FDA will begin to implement the landmark Food Safety Modernization Act and also empower Americans to make healthier food choices. FDA will establish a prevention-focused food safety system and leverage the valuable work of FDA's state and local food safety partners. The result will be a stronger, 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.
• Advancing Medical Countermeasures ($70 million) Initiative: This increase will ensure that 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. With this initiative, FDA will enhance its review of countermeasures and develop and apply new tools and standards to speed the development of MCMs. To improve public health response, FDA will also modernize the legal, regulatory and policy framework that governs development and availability of MCMs.
• Protecting Patients Initiative ($124 million): 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.
• Regulatory Science and Facilities Initiative ($49 Million): 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.