Abstract

This case details the new product development and approval of Posilac®, an animal drug product pioneered by the Monsanto Company. The product is a genetically engineered hormone known as bovine somatotropin and was targeted for sale to dairy farmers to enhance the milk production of their herds. At the time of its development and subsequent introduction to the market, Posilac® represented one the first applications of genetic engineering in food production and as such, it became a lightning rod for controversy. As Monsanto sought approval for this product from the U.S. Food and Drug Administration, it encountered vigorous opposition from a variety of consumer and trade interests. The case recounts the arduous approval process and explains how industry and public policy debates largely focused on issues of product labeling