FDA Approves First Drug Made From Genetically Engineered Animals

February 06, 2009 04:14 PM
by Christopher Coats
Reflecting a new acceptance of genetically engineered animals, the Food and Drug Administration approved a drug manufactured using milk from altered goats.

FDA Makes History With ATryn

The drug, a blood thinner called ATryn, was created by injecting DNA from human antithrombin protein—a protein that acts as a natural blood thinner—into single cell goat embryos. These embryos were then implanted into the wombs of surrogate goats that gave birth to baby goats that produce extra antithrombin in their milk.

ATryn has only been approved in the United States for use in pregnant women and patients undergoing surgery; the blood thinner was approved in Europe in 2006.

The approval comes after the FDA released a broad set of new guidelines regarding genetically altered animals, both for consumption and research.

Released on Jan. 15, the guidelines suggest a more open acceptance of genetically altered animals, and don’t require labels on food products made from these animals.

Supporters of enhanced animals argue that they can be used to provide healthier, faster-growing food supplies and aid in the development of medical treatments by playing host to the production of needed proteins, as in the creation of ATryn.

Opponents warn of the unintended consequences of altering the genetics of animal cells, however, though their main point of contention with the new FDA guidelines is the issue of labeling.

Genetically engineered insects
have been approved by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service in an attempt to save Florida’s orange groves from predatory insects. But this marks the first time the use of genetically engineered animals has been approved in the United States.

Most Recent Beyond The Headlines