Normalizing the exceptional: incorporating the "abortion pill" into mainstream medicine

Mifepristone, also known as RU-486, and in the US known as "the French abortion pill", finally received FDA approval in the United States in September 2000. This paper discusses the steps now in process to integrate this drug into mainstream healthcare and the sociological implications of those efforts. Each of the steps that is normally taken to introduce a newly approved medication in the US context is rendered highly complex in the case of mifepristone-because of the unique circumstances of abortion in both American culture generally, and medical culture specifically. The story of RU-486/mifepristone, as it is currently unfolding, can be understood as one of attempting to "normalize the exceptional". After offering a brief historical overview of the protracted struggle for FDA approval of mifepristone in the US, this paper discusses the typical processes for integration of a newly approved medication into mainstream medicine and contrasts this process with the special challenges posed by a drug that is associated with abortion. We outline the challenges to implementation, including both external and internal obstacles. We compare the traditional role of a pharmaceutical company in drug diffusion and the circumstances of the company that produces mifepristone in the US. We discuss such external obstacles as the conflict between the FDA-approved regime and an evidence-based alternative; the necessity for physicians to order and dispense this drug; the ambiguity over the need for ultrasonography; and insurance reimbursement, malpractice, and other legal issues. Internal issues addressed include "turf issues" between medical specialties and between physicians and advanced practice clinicians as well as concerns over "cowboy medicine", and patient compliance. This paper concludes with an exploration of the sociological implications of this effort to "normalize the exceptional". (C) 2002 Elsevier Science Ltd. All rights reserved.