SPL Responds To FDA Commissioner's Speculation That Motive For The Contamination Of Heparin May Have Been Economic Fraud

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 16 Apr 2008 - 3:00 PDT

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FDA Commissioner von Eschenbach speculated that the motive for the contamination of heparin may have been economic fraud. He could not have been referring to Scientific Protein Laboratories (SPL) or Changzhou SPL when he made this statement. Based upon testing and reports from around the world, 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. Moreover, the products of many heparin ingredient and finished product manufacturers around the world also contained the contaminant. 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.

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