Autonomy, Isotretinoin and iPLEDGE: The Ethics of Burdensome Regulation and Use of Teratogenic Medication

Abstract

The United States Food and Drug and Administration (FDA) approved isotretinoin (Accutane™) in 1982 for the treatment of nodulocystic acne. While there is well-documented efficacy for the FDA-stated indication and keratinizing disorders, there is equally significant and well-documented associated teratogenicity. The US government has instituted three progressively more involved programs intended to eliminate fetal exposure to isotretinoin. The current risk management program (RMP), known as iPLEDGE, was initiated in 2005.

iPLEDGE raises several ethical concerns. First, the program necessarily (and intentionally) restricts patient autonomy by strictly regulating access to the medication. Furthermore, these restrictions are unevenly applied as the requirements for a woman of childbearing potential to access the medication are far more burdensome than those for other patients. A third ethical concern is that dermatologists opposed to elective pregnancy termination may not be comfortable prescribing isotretinoin to women of childbearing age, or possibly even referring them to other willing dermatologists. Finally, since nodulocystic acne often affects minors, ethical challenges regarding physician-minor and parent–child confidentiality may also arise.