U.S. Regulation of Biopharming in Animals

Within the U.S. government, the FDA has the lead in regulating biopharming in transgenic farm animals. On September 19, 2008, FDA announced that it would regulate pharma animals as “new animal drugs,” meaning that a mandatory pre- market review for safety and efficacy is required before companies can market pharmaceutical products made in transgenic animals.

Although this policy is rather unusual, it is consistent with the U.S. approach to regulating genetic engineering based on the end-product rather than the process. According to the FDA’s definition, a drug is something that changes the structure or function of the person or animal taking it. Because a transgene inserted into an animal’s genome changes its structure and function, and because the inserted gene is inseparable from the host, the entire transgenic animal is viewed as a product that must be regulated as though it were a drug.

The production of ATryn in lactating transgenic goats, for example, had to go through two FDA approval processes. First, FDA had to make sure that the drug itself is safe and effective, and second, transgenic goats (the production system) also had to be approved as a new animal drug. This process requires demonstrating that the drug is safe for the animal, safe for human consumption, and safe for the environment. The FDA performs all three assessments. In contrast, the biopharming of proteins for diagnostic purposes, rather than human consumption, does not require FDA approval.¹⁵

The FDA does a rigorous job in assessing the safety of biopharming in animals in relation to the informal consultation process involved for biopharming in plants. The main drawback of the FDA regulations is that the application and approval process for producting pharmaceuticals in transgenic animals is nontransparent, with no public participation. FDA staff are prevented by law from revealing information about any drug pending before the agency from the investigational stage until final approval. Thus, the only information available about transgenic animal products currently in the development pipeline, such as AquaBounty salmon or the EnviroPig, is because the sponsors have decided voluntarily to inform the public.

The 2002 National Research Council report on animal biotechnology concluded that environmental impacts are the greatest “science-based concern” associated with transgenic animals. Although FDA is well equipped to address food safety, it lacks the expertise to address the ecological concerns associated with the escape or release of transgenic animals into the environment. Moreover, although FDA can deny an application for biopharming if it is harmful to the animal involved or if food produced from the animal is unsafe for human or animal consumption, the agency does not have the authority to deny a new drug application based on its environmental impact alone.¹⁵