Abstract:
The pharmaceutical called RU 486--a pill which could induce miscarriage early in pregnancy--has taken its place in the pitched politics surrounding abortion. This case tracks the development and marketing of the pill with particular emphasis on the role which government agencies in France and the United States have been, or may be, called upon to play in regulating it. Among the key junctures in the case is when the French government orders continued production of the pill after the manufacturer had bowed to the pressure of anti-abortion groups and agreed to halt its sale. The French decision is complicated by the fact that the French government had supported research and development of RU 486 and maintained an ownership interest in the pharmaceutical firm manufacturing it. There is a further complication for both French and, later, US regulators: In addition to its role in inducing abortion, the drug has also been shown to have beneficial effects in treating breast cancer, brain tumors and a rare and fatal disease called Cushing's syndrome.
Learning Objective:
Although primarily a compendium of the history of the RU 486 controversy from 1988 through 1990, the case allows for a general discussion of the regulatory process and the extent to which it must be cognizant of social and political pressures.
