FDA Approves First Biological Product Derived From Genetically Engineered Animals

By Ricardo Carvajal –      

FDA has approved the biological product ATryn, an anticoagulant derived from the milk of genetically engineered ("GE") goats.  The approval follows on the heels of the agency’s issuance of long-awaited guidance on its regulatory approach to GE animals, which we discussed in a prior posting.  Responses to the agency’s approval of ATryn are already raising concerns about animal welfare, environmental effects, and food safety.  FDA’s press release attempts to address all of these concerns. 

With respect to food and feed safety, the approval of ATryn is conditioned on exclusion of the goats from  the food and feed supply.  A Freedom of Information summary of the NADA lists the following as control measures supporting a conclusion that there exists a “reasonable certainty” that the GE goats won’t enter the food supply:

• Secure locked fencing around the entire facility, with double fencing around animal paddocks;
• Well maintained secure barns leading to fenced paddock and exercise yards;
• Round-the-clock staffing of the facility;
• Active on-site security with personnel supplemented with video surveillance;
• SOPs for animal identification and disposal that include procedures to ensure that all GE animals are identified by ear tag, tattoo, and implanted identification chip;
• all animals are incinerated at termination use.