FDA Change of Plan B One-Step Label: Points to Consider

Abstract

On December 23, 2022, the US Food and Drug Administration (FDA) changed its Drug Facts Label for Plan B One-Step (PBOS), removing language that, since 2006, had stated that PBOS “may inhibit implantation (by altering the endometrium).” The FDA’s action has created the impression that PBOS and similar, generic levonorgestrel-based drugs used for “emergency contraception” (LNG-EC) have no effect on the survival of a conceived human being. The FDA did not address all factors relevant to how LNG-EC can impact human life after fertilization. These factors, and other ethical questions surrounding the change, are discussed in this article by the NCBC ethicists