The United States Food and Drug Administration (FDA), in collaboration with pharmaceutical manufacturers, have recently implemented a heavily revised risk-management program for patients on isotretinoin (Accutane), a drug with known and pronounced teratogenic effects. This revised risk management plan places significant burdens on both providers and patients in the hopes of achieving its goal of reducing fetal exposure to isotretinoin. The main focus of this paper is to discuss the burdens of various aspects of the program in relationship to potential corresponding benefits. In particular, we evaluate the pregnancy rates of women on isotretinoin therapy compared with that of the general population and the rate changes based on the risk management programs. Additionally, we investigate whether the benefits of the program for women have increased as the benefits have risen. We devote special attention to the ethical implications of the intent of the program and to an analysis of the ethical justification of the restrictions placed on women of childbearing potential (WCP) as it compares to the risk-benefit relationship of using isotretinoin.

Original languageEnglish (US)
Pages (from-to)104-117
Number of pages14
JournalJournal of Law, Medicine and Ethics
Issue number1
StatePublished - Mar 2009

ASJC Scopus subject areas

  • Issues, ethics and legal aspects
  • Health Policy


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