FDA Criticized, p2

FDA Criticized, p2

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The report notes that the agency’s computer systems are aging and prone to breakdowns, “most recently during an E. coli food contamination investigation.”

“Reports of product dangers are not rapidly compared and analyzed, inspectors’ reports are still handwritten and slow to work their way through the compliance system, and the system for managing imported products cannot communicate with customs and other government systems,” the report stated.

The agency often misses significant product arrivals because its computers are so poor that they cannot distinguish between shipments of road salt and those of table salt, the report said.

The Institute of Medicine, the nation’s most prestigious scientific advisory organization, concluded last year that the agency’s system for ensuring the safety of drugs needed an overhaul. Recent legislation enacted some of the institute’s recommendations.

More hearings regarding the F.D.A.’s oversight of food are in the offing, including one in the Senate on Tuesday. The report concluded that the “F.D.A.’s ability to provide its basic food system inspection, enforcement and rule-making functions is severely eroded, as is its ability to respond to outbreaks in a timely manner.”

Garret A. FitzGerald, a pharmacologist from the University of Pennsylvania and adviser to the authors, said the report was raising an alarm because “this is a crisis.” Dr. FitzGerald pointed to a series of food and drug scares that have demonstrated how little oversight the F.D.A. provides.

He blamed a “cabal of Congressional majorities and presidential administrations that has serially stripped the agency of assets.”

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Evmim

1 Year, 2 Weeks, 1 day, 18 hours, 28 minutes ago

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