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Watchdog Group Wants Probe in Syringe Case


June 8, 2009
By Christina Jewett
ProPublica & Chris Walker, Chicago Tribune

The Food and Drug Administration’s failure to stop contaminated syringes from reaching the market should be investigated by the agency’s inspector general, a watchdog group said Monday.

The call by the Project on Government Oversight, or POGO, followed publication last weekend of a ProPublica [1] and Chicago Tribune [2]  report that said the FDA missed chances to act before a contaminated lot of 74,000 syringes was shipped. Authorities connected four deaths and 162 illnesses to the syringes.

"It’s clear that the FDA fell down on the job despite many strong warnings that the company, AM2PAT, could not be trusted," said Dr. Ned Feder, staff scientist and co-author of the letter [3] sent to the FDA and Health and Human Services Inspector General office.

Review of the 2007 case would shine "light on the institutional weaknesses at the FDA that led to regulatory failures in other episodes that are more complicated and more difficult to investigate," he said....

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