Scientific Protein Laboratories LLC Statement Regarding FDA Briefing On Heparin Products Made By Baxter

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals;  Autism
Article Date: 06 Mar 2008 - 3:00 PDT

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The following statement was issued by Scientific Protein Laboratories LLC (SPL) following the press briefing held by the Food and Drug Administration (FDA) on its investigation into adverse events associated with the use of heparin products made by Baxter:

Patient safety remains SPL's paramount concern. SPL has been working aggressively with the FDA and Baxter, as well as with outside experts, to identify the root cause of the adverse events seen in Baxter products. Thus far, no conclusions have been reached about the root cause. It is premature to conclude that the heparin active pharmaceutical ingredient (API) sourced from China and provided by SPL to Baxter is responsible for these adverse events.

During the call with the media, FDA speculated that the source of the adverse events may be a contaminant. It is important to note that this theory is speculation at this point, and SPL is participating actively in working with the FDA to pursue this theory as well as others so that we can understand the cause of the adverse events.

However, SPL has committed to the FDA to voluntarily remove from the market any lots of China-sourced heparin API where tests have indicated the presence of an extra signal/peak in testing. Today, SPL is notifying its customers who have received certain lots of that API material.

SPL emphasizes that this voluntary action, which has been closely coordinated with the FDA, is being taken strictly as a precaution.

As an update, Changzhou SPL is preparing its response to the observations made by the FDA during a recent inspection of its facility. It is important to emphasize that the root cause of the heparin adverse events has not been tied to any of the agency's observations.

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