The U.S. FDA has issued draft guidance for the use of genetically engineered animals to produce drugs.
At present, very few drugs produced in GE animals have reached the commercial market, but this is expected to change in coming years.
Drugs produced within GE animals are, like those produced by more traditional means, subject to safety and effectiveness tests by the Center for Drug Evaluation and Research (CDER).
Measures intended to minimize the likelihood of the animal or its products being inadvertently released from the production site are also included in the FDA document, which covers issues related to the shipping, labeling and storage of GE animals.
The FDA recommends incineration, burial, or composting of deceased animals to ensure that edible parts of them do not enter the food supply.