UPDATE – 12/1/09 – From Reuters: “Company data showed the drug was safe and effective, a majority of the Food and Drug Administration’s 19-member panel voted. The FDA will consider the advice in making its decision, expected by February 7.”

A drug produced by genetically modified goats could soon be approved for the US market.

An expert advisory committee of the Food and Drug Administration will today consider anti-clotting treatment ATryn, which is already approved for use in Europe.

“On the basis of the development activities and data generated over the last 16 years, the Applicant maintains that ATryn has been shown to be safe and efficacious,” says an FDA advisory committee in a report released on Wednesday (pdf). “As such, ATryn should be recommended for licensure for the treatment of a rare plasma protein disorder to prevent serious and potentially life-threatening venous thromboembolic events.”

The GM goats produce human antithrombin in their milk, which can then be used to treat patients with hereditary antithrombin deficiency, a genetic condition that can lead to life-threatening blood clots.

If approved, ATryn will be the first GM-animal produced drug licensed in the US. It’s not likely to be the last though, as Wired notes:

Some protein-based drugs can be produced by microbes like yeast, but others require the special touch of mammalian cells. Giant pharmaceutical companies make batches of medication in sophisticated tanks called bioreactors, which are often filled with Chinese hamster ovary cells. But that method is very costly.

By comparison, using goats as living, grass-chewing factories is elegant and inexpensive. Because the drug is only produced in their mammary glands, it doesn’t cause health problems for the goats.

Geoffrey Cox, chairman of the drug’s manufacturer GTC, told AP, “The real dramatic thing that is happening here is that we’ve been able to reduce some very clever science to the practical level of producing a drug that’s safe and efficacious. Those things aren’t trivial.”

Some are unhappy though.

“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,” Greg Jaffe of the Center for Science in the Public Interest pressure groups told USA Today. “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.”