Federal Budget Proposal Bolsters FDA

by Barbara Kram, Editor | February 06, 2007
FDA Commissioner Andrew
von Eschenbach, MD asked the
President for almost $2.1 billion
to protect public health and safety.

click to enlarge
The U.S. Food and Drug Administration (FDA), part of the U.S. Department of Health and Human Services, is requesting nearly $2.1 billion to protect and promote public health as part of the President's fiscal year (FY) 2008 budget-more than a 5 percent increase over the budget submitted to Congress last year.

The FY 2008 request, which covers the period of Oct. 1, 2007 through Sept. 30, 2008, includes $1.64 billion in budget authority and nearly $444 million in industry user fees. The budget proposal includes significant increases to strengthen food safety, modernize drug safety, speed approval of generic drugs, and improve the safety and review of medical devices. The request also includes significant increases to cover higher infrastructure expenses and cost of living adjustments for FDA employees to support the agency's highly trained and specialized public health workforce. These investments will accelerate the availability of new and innovative medical products and help ensure the safety of the food supply.

"As the FDA enters its second century of service, our focus will continue on critical public health initiatives, including ensuring the safety of the food we eat and the safety and effectiveness of the medicines we take," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "The President's budget provides FDA with a sound approach for meeting its public health mandate and priorities for the American people."

The following are FDA's key proposed budget increases:

* Strengthening food safety ($10.6 million)
More than 250 different foodborne illnesses are food safety threats. Recent illnesses linked to fresh produce highlight the need for increased resources to strengthen food safety and enhance FDA's ability to reduce and respond to foodborne outbreaks. Additional funding will allow the agency to develop better methods to rapidly detect foodborne illness, track contamination to its source and help states, local jurisdictions and industry mitigate the risks of new outbreaks.

* Modernizing drug safety ($11.2 million)
FDA needs additional resources to build on the strong record of safe and reliable drugs that has made the agency a long-time international gold standard of drug regulation. FDA is proposing to further strengthen the science that supports its medical product safety system at every stage of the product life cycle, from pre-market testing and development through post-market surveillance and risk management. With added funds, FDA will increase staff devoted to review of annual safety reports, conduct a pilot program to review the safety profiles of new molecular entities and develop an electronic drug safety tracking system.