FDA PROPOSES BANNING HIGH-RISK CATTLE MATERIAL FROM MEDICAL PRODUCTS

The FDA wants to prohibit certain cattle material from drugs, biologics and medical devices to lower the risk of bovine spongiform encephalopathy (BSE or mad cow disease.)

Companies would have to keep records proving that any cattle material used in their medical products meets the FDA's requirements, the agency said last week.

Under the proposed regulation, the banned products could not be used as ingredients in medical products or as a part of their manufacturing processes, the FDA said.

The rule would ban cattle materials that have been found to have the highest concentrations of the BSE agent. They include:

• The brains, skulls, eyes and spinal cords from cattle 30 months and older;
• Tonsils and a portion of the small intestines from all cattle;
• Any material from cattle that cannot walk;
• Any material from cattle not inspected and approved for human consumption;
• Fetal calf serum if procedures have not been followed to prevent its contamination with other banned materials;
• Tallow containing more than 0.15 percent insoluble impurities if derived from banned materials; and
• Mechanically separated beef.

The rule would cover prescription, OTC and homeopathic drugs, as well as biologics, medical devices and drugs for use in ruminant animals like cattle and sheep, the agency said.

The FDA noted the possible link between outbreaks of mad cow disease and the human disease variant Creutzfeldt-Jakob disease (vCJD). When humans ingest contaminated cattle products containing the BSE agent, it could lead to vCJD, the agency said.