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From: TSS ()
Subject: FDA SCIENCE AND MISSION AT RISK they been bushwhacked too
Date: December 5, 2007 at 2:08 pm PST

Report says stingy funding has put FDA in crisis

Dec 5, 2007 (CIDRAP News) – Safety inspectors still write their reports by hand, food processing plants are inspected once every 10 years at best, only two people work full-time on pet-food safety, and critical information is locked up in piles of warehoused paper documents.

Those are a few symptoms of the poor condition in which the US Food and Drug Administration (FDA) finds itself after decades of inadequate funding and growing responsibilities, according to a new report by a special FDA committee that was assigned to assess the agency's scientific and technological capabilities.

The bottom line is that "American lives are at risk," says the 60-page report, titled "FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology."

The report says the agency is losing its ability to keep up with scientific advances, its regular staff has stayed about the same size for 20 years, and its information technology (IT) systems are obsolete and unreliable.

"We found that FDA's resource shortfalls have resulted in a plethora of inadequacies that threaten our society—including, but not limited to, inadequate inspections of manufacturers, a dearth of scientists who understand emerging new technologies, inability to speed the development of new therapies, an import system that is badly broken, a food supply that grows riskier each year, and an information infrastructure that was identified as a source of risk in every Center and program reviewed by the Subcommittee," the report states.

The report suggests the agency may need as much as twice its current level of funding to equip it properly to fulfill its mission.

The document's release comes less than a month after the Bush administration released an import safety and food protection plan triggered by a series of tainted imports, including contaminated pet food and toys with lead paint, plus recent domestic food contamination episodes, such as instances of Salmonella in peanut butter and E coli in fresh produce.

The FDA' s mission includes regulating about 80% of food sold in the United States, plus all drugs, human vaccines, and medical devices, the report notes. The products the agency regulates account for about 25 cents of every consumer dollar spent—about $1 trillion per year.

A year ago, FDA Commissioner Andrew von Eschenbach asked his advisory board, called the FDA Science Board, to name a subcommittee to weigh whether the agency has the scientific and technologic capacity to support its regulatory mandate, the report say



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