The FDA has approved the first drug produced by livestock that have been given a human gene. The drug is meant to prevent fatal blood clots in people with a rare condition. It is a human protein which will be extracted from the milk of genetically engineered goats.
The FDA also approved the goats used to make the drug, the first such animals cleared under guidelines the agency adopted just last month to regulate the use of transgenic animals in the U.S. drug and food supply.
Proponents say such “pharm animals” could become a means of producing biotechnology drugs at lower cost or in greater quantities. But there are also 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, with unpredictable consequences.