HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Tuesday, February 10, 2009

Meet the New Farma . . .

The New York Times reports on the FDA's approval of  a new drug made from a goat that had been given a human gene.

Images Opening the barn door to a new era in farming and pharmaceuticals, the Food and Drug Administration on Friday approved the first drug produced by livestock that have been given a human gene. The drug, meant to prevent fatal blood clots in people with a rare condition, is a human protein extracted from the milk of genetically engineered goats.

At the same time, the F.D.A. also approved the goats used to make the drug, the first such animals cleared under guidelines the agency adopted only last month to regulate the use of transgenic animals in the nation’s drug and food supply.

Made by a company called GTC Biotherapeutics, the human anticlotting protein is produced by a herd of 200 bioengineered goats living under carefully controlled conditions on a farm in central Massachusetts.

Proponents say such “pharm animals” could become a means of producing biotechnology drugs at lower cost or in greater quantities than the existing methods — which include extracting proteins from donated human blood or growing them in large steel vats of genetically engineered cells.

The protein in the goat milk, antithrombin, is sometimes in short supply or unavailable for pharmaceutical use because of a shortage of human plasma donations. GTC Biotherapeutics said one of its goats can produce as much antithrombin in a year as can be derived from 90,000 blood donations. And if more drug is needed, the herd can be expanded. . . .

Turning animals into walking drug producers does not sit well with some environmental advocates and animal rights activists. “It is a mechanistic use of animals that seems to perpetuate the notion of their being merely tools for human use rather than sentient creatures,” the Humane Society of the United States says in its position paper on the practice.

There are other concerns: that the animals could be harmed, that animal germs might contaminate the drug, that the milk or meat from genetically engineered drug-producing animals might enter the food supply or that the animals might escape and breed with others, spreading the gene, with unpredictable consequences.

But the F.D.A. approval could now encourage drug makers to consider this type of production.  The F.D.A.’s move “really takes away one of the biggest issues that have always been on the table, which is how do regulatory agencies view this kind of technology,” said Samir Singh, president of the American operations of Pharming, another company using such technology.. . . .

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