The Food and Drug Administration (FDA) has approved the first commercialization both of a drug from a genetically engineered (GE) animal and of the animal itself. Although the agency previously assured the public that it would offer opportunities for public input into decisions to approve GE animals, the FDA made the approval without requesting input either from the public or an FDA advisory committee. The animal is a goat engineered to produce milk containing a human protein that is intended to prevent blood clots. A Massachusetts company is raising a herd of the GE goats to produce the protein. Under the FDA's process, there were no discussions of the safety or ethical implications of the approval, nor were regulations developed to keep the goats and their milk from contaminating the food supply. The FDA is using drug laws as the basis to regulate all GE animals, even though most GE animals do not produce drugs, and even though the drug laws affirmatively discourage public participation, transparency, and appeal of approvals. Read more from The New York Times.
|"The behind-closed-doors process used to approve the first GE animal shows why the use of the drug laws for GE animals is wholly unacceptable. We need new legislation to require a transparent, participatory regulatory system for GE animals." ~ Margaret Mellon, Food & Environment Program Director|