FDA budget requests $4.7 billion

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration 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 percent 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. "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 United States, 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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Most Popular Now

Merck Granted U.S. Patent for novel combination of…

Merck, a leading science and technology company, today announced that it has been granted Patent No. US 10,193,695 by the United States Patent and Trademark Office (USPTO...

Forxiga receives positive EU CHMP opinion for the …

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a new indication for the marketing authorisation of Forxi...

Pfizer receives positive CHMP opinion for Vizimpro…

Pfizer today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending V...

Amgen and UCB receive positive vote from FDA Advis…

Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) announced strong support from the U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advis...

Pfizer and Lilly announce top-line results from se…

Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced positive top-line results from a Phase 3 study evaluating tanezumab 2.5 mg or 5 mg in patients...

US FDA grants Breakthrough Therapy Designation for…

AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Ther...

Merck welcomes ten new startups to its Innovation …

Merck, a leading science and technology company, today announced the ten startups that will be joining the seventh intake of its Accelerator program at the Merck Innovati...

Merck and Tencent announce collaboration on intell…

Merck, a leading science and technology company, signed a strategic collaboration agreement with Tencent, a leading provider of Internet value added services. The collabo...

Merck to expand US biopharmaceutical R&D facil…

Merck, a leading science and technology company, today announced a $70 million investment to expand its state of the art research and development (R&D) facility in Biller...

New pill can deliver insulin

An MIT-led research team has developed a drug capsule that could be used to deliver oral doses of insulin, potentially replacing the injections that people with type 2 di...

Researchers call for big data infrastructure to su…

Researchers from the George Washington University (GW), the U.S. Food and Drug Administration (FDA), and industry leaders published in PLOS Biology, describing a standard...

New computational method reduces risk of drug form…

One major factor that determines the efficacy of a drug is the structure that its molecules form in a solid state. Changed molecular structures can entail that pills stop...