The proposed measures would apply to drugs (including prescription, over-the-counter and homeopathic), biologics (such as vaccines) and medical devices for human use, as well as drugs for use in ruminant animals.
To ensure companies comply with the new regulations, the FDA has proposed records be kept demonstrating that any cattle material used as an ingredient in medical products or as part of the manufacturing process meets FDA standards.
A variety of bovine-derived materials have traditionally been used in the manufacture of biological and pharmaceutical products, including milk and milk derivatives (such as lactose), meat extracts, bovine serum, bovine bone gelatine and beef tallow derivatives.
These latest regulations are intended to remove the risk associated with materials that are seen to pose the highest risk of containing infectious material, but could cause difficulties for those companies relying on bovine products for processing or product manufacture.
- The brain, skull, eyes and spinal cords from cattle 30 months and older;
- The tonsils and a portion of the small intestines from all cattle regardless of their age or health;
- Any material from 'downer' cattle - those that cannot walk;
- Any material from cattle not inspected and passed for human consumption;
- Foetal calf serum if appropriate procedures have not been followed to prevent its contamination with materials prohibited by the proposed rule;
- Tallow that contains more than 0.15 per cent insoluble impurities if the tallow is derived from materials prohibited by the proposed rule;
- Mechanically separated beef.
Strong evidence has accumulated suggesting a causal relationship between bovine spongiform encephalopathy (BSE) found in cattle, and variant Creutzfeldt-Jakob disease in humans (vCJD). The diseases belong to a group of progressive, degenerative neurological diseases known as transmissible spongiform encephalopathies (TSEs), but the specific products associated with the transmission of the BSE agent to humans (causing vCJD) are currently unknown.
In 2003 the World Health Organisation (WHO) produced guidelines on TSEs in relation to biological and pharmaceutical products, stating:
"The ideal situation would be to avoid the use of bovine materials in the manufacture of any biological or pharmaceutical product, as well as the use of materials from other animal species in which TSEs naturally occur. In practice, this is not always feasible…"
The FDA and US Department of Agriculture have implemented a series of safety measures since the outbreak of mad cow disease to try and protect the public from vCJD. Regulations were further tightened after cases of BSE were reported in the US, which lead to the US and Canada being upgraded to Geographical BSE Risk (GBR) III status by the European Food Safety Authority in 2004.
Omrix move pays off
In the light of the FDA's continuing precautions to protect against the spread of vCJD, Omrix Biopharmaceuticals may have hit the jackpot by deciding to develop human derived thrombin that does not contain any material of animal origin.
While currently commercially available bovine thrombin is not currently on the FDA's prohibited materials list, there is every possibility that it could be added at a later date. A potential ban on the material would be bad news for Omrix's competitors, but would leave Omrix in a very strong market position.
Shares in the company hit an all-time high after news of the FDA proposals was announced last week.