Positive step for drug from engineered goat

— -- In a surprise move, it seems likely the first genetically engineered animal approved for commercial use won't be a fast-growing salmon, as was expected, but a goat that produces an anti-clotting drug in its milk.

A Food and Drug Administration evaluation released Wednesday found that the drug Atryn is effective and safe.

The report will be presented Friday to FDA's Blood Products Advisory Board. Made up of outside experts, the panel will vote on whether to approve the application. If approved, the drug will have crossed the first hurdle toward acceptance, says FDA spokeswoman Siobhan DeLancey. There are still more steps in the FDA's drug-approval process.

The drug is being produced by GTC Biotherapeutics for use in people with a hereditary disorder that makes them vulnerable to life-threatening blood clots. It is used during surgery and childbirth.

If the drug is approved, it would be the first application under new FDA regulations that allow animals to be genetically altered to produce drugs, model human disease, produce industrial or consumer products or improve their use as food.

Many consumer groups are concerned about using animals to make such products.

"The regulatory process seems to have put the cart before the horse, analyzing the safety of the product before it has opined on the safety of the manufacturing process," says Greg Jaffe of the Center for Science in the Public Interest. "FDA clearly needs to impose cradle-to-grave conditions to prevent the goats from leaving the farm or their products from entering the food supply."