When Cows Go Oink, Pigs Go Baaa, and Sheep Go Moo: Development and Regulatory Challenges of Intentional Genomic Alterations in Animals

Alessandro Stasi & Roman Meinhold


This Article attempts to clarify the regulatory rationale behind FDA’s guidance for industry #187 on genome-edited animals. It also addresses a critical gap in the literature: few scholars have evaluated the risks associated with genome editing in animals from a legal perspective, and none have assessed the question of whether the regulation of intentional genomic alterations in animals is in line with current scientific and technological standards. The Article comes to the conclusion that FDA should continue to use the reasonable set of criteria it has laid down in the guidance for industry #187 and evaluate intentional genomic alterations in animals as a new animal drug. Some policy recommendations are also suggested in this study for further development.