Devices

Charles River Wants Endotoxin Assay Regulation

Charles River Laboratories is petitioning FDA to change its regulation of endotoxic contamination assays, including licensure of all such assays, to include those that are currently unlicensed. The Charles River 8/1 petition says that for the past 50 years, the leading assays used to detect possible endotoxic contamination in biological products, pharmaceuticals, and medical devices depended on the activity of Limulus Amebocyte Lysate (LAL), which is prepared from the blood of horseshoe crabs.

In recent years, it says, synthetic alternatives to LAL have been marketed for use in endotoxin contamination testing without FDA premarket authorization. It says an agency ombudsman determined in 2003 that a Cambrex Bio Science assay was not subject to any regulatory oversight.

“Whatever merit the Cambrex letter may have had in 2003,” the petition says, “it is legally indefensible today.” Charles River notes that Congress in 2010 amended the definition of a biological product, eliminating the distinction between natural and synthetic products.

The petition asks the agency to:

formally rescind the “now-obsolete” ombudsman’s letter;
declare that any person engaged in the interstate commercial marketing of an end-product endotoxin test for human drugs, biological products, or medical devices that includes recombinant Factor C and does not have an effective BLA for the recombinant Factor C product violates the law;
order such persons to either stop marketing their unlicensed and unlawful product or submit a BLA; and
initiate prompt enforcement proceedings against any persons who either fail to comply with the requested order or fail to obtain approval for the submitted BLA.

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