The FDA is requesting a budget of $4.7 billion to protect and promote the public health as part of the President's fiscal year (FY) 2014 budget. Industry user fees would fund 94% of the proposed budget increase, including new fees to support the landmark Food Safety Modernization Act (FSMA) and strengthen the FDA's ability to oversee imported food.

The remainder of the budget increases would support programs which are necessary to preserve the safety of medical products and meet the agency's growing duties. Recognizing the need for fiscal constraint, the budget includes spending cuts in several areas, including a $15 million decrease in budget authority for human drug, biologics and medical device programs.

"These are tight budget times, and the FDA budget request reflects this reality," said Margaret A. Hamburg, M.D., commissioner of food and drugs, FDA. "Our budget increases are targeted to strategic areas that will benefit patients and consumers and overall strengthen our economy. Through the good work of the FDA, Americans will receive life-saving medicines approved as fast as or faster than anywhere in the world, confidence in the medical products they rely on daily, and a food supply that is among the safest in the world."

The FY 2014 request covers the period from Oct. 1, 2013 through Sept. 30, 2014. Highlights of the FDA FY 2014 budget include:

Transforming Food Safety: +$295.8 million ($252.4 million in User Fees / $43.4 million in budget authority) above the FY 2012 level will bolster the FDA's efforts to build a strong, reliable food safety system. Most of these funds are needed to support implementation of the FSMA, which provides authorities and mandates for the FDA to build a modern, prevention-focused domestic and imported food safety system to protect the health of American consumers. The budget proposes a food facility registration and inspection fee and a food importer fee. The FDA is also proposing new user fees to support its cosmetic and food contact substance notification programs. The President's budget proposes a fee to be paid by food importers that would both improve the safety of the food supply as well as ensure the smooth and predictable entry of safe foods into the U.S., thus enhancing trade by domestic and overseas trading partners.

White Oak Consolidation: +$17.9 million above the FY 2012 level will support the outfitting and required certification and operation of the Life Sciences-Biodefense Complex (the FDA's White Oak headquarters in Silver Spring, Md.) to carry out cutting-edge research to ensure that the FDA is providing the best possible oversight over its regulated products to protect the American public. This is a cornerstone of the FDA's effort to modernize regulatory science and promote medical product innovation.

Food and Drug Safety Inspections in China: +$10 million above the FY 2012 level will support the FDA's capacity to detect and address the risks of products and ingredients manufactured in China and to help assure that these products do not result in harm to Americans.

Medical Countermeasures (MCM) Initiative: +$3.5 million above the FY 2012 level will help meet America's national security and public health requirements for MCM readiness. The additional resources in FY 2014 will support science and partnerships to improve MCM development timelines and the success rates for MCMs.