FDA: Heparin tainted by "fraud"

WASHINGTON, D.C.; April 15, 2008

FDA chief Dr. Andrew von Eschenbach told a Senate hearing today that fraud motivated by greed was the likely motive.

Von Eschenbach says the contaminant, which imitates heparin, was probably cheaper to make than the real thing.

He says there's no specific evidence yet.

The raw heparin was made in China.

Scientific Protein Laboratories, the Chinese company that produced the heparin, released a statement today saying "it is clear that the contamination occurred on a widespread basis earlier in the Chinese heparin raw material supply chain, before those materials reached Changzhou SPL and SPL."

"It is clear that there was no possibility of economic benefit to SPL, Changzhou SPL, or its customers. In fact, SPL and Changzhou SPL's price for raw materials increased during the relevant time period."

"SPL has a thirty-year record of quality, and both SPL and CZSPL have been inspected and there is no link between any inspectional findings and the contaminant. Heparin sourced and processed by SPL in North America has not been implicated. SPL continues to cooperate with FDA and Chinese officials in investigating this matter."

At least 62 deaths have been tied to the drug.

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