December 30, 2022

FDA Changes Plan B Label to Remove Abortifacient Warning

The US Food and Drug Administration has changed the label for Plan B One-Step "emergency contraceptive" to remove a warning that the drug can function as an abortifacient.

Plan B is an over-the-counter drug that prevents pregnancy by preventing ovulation, blocking fertilization, or preventing a fertilized egg from implanting in the uterus. In the third of these scenarios, an abortion occurs. A fertilized egg is a unique and innocent human being with a right to life. When Plan B prevents fertilized eggs from implanting in the uterus, those humans die.

The new label reads "Plan B One-Step will not work if you are already pregnant and will not affect an existing pregnancy."

The FDA explained its reasoning for the change in a public decisional memorandum. The memorandum argues that the active drug in Plan B, levonorgestrel (LNG) “does not terminate an established pregnancy and does not affect a continuing pregnancy.” The FDA concluded, “In summary, LNG-EC is shown to act primarily by interfering with ovulation (delay or inhibition of follicle rupture and/or the midcycle LH and related hormonal changes) and not to act through direct effect on fertilization or on the endometrium to impede implantation.”

This claim is contradicted by other studies. In 2014, one year after Plan B became available over the counter, the Charlotte Lozier Institute analyzed a group of studies analyzing the abortifacient potential of emergency contraception. The institute wrote in its assessment, “All point to Plan B’s having a predominantly post-fertilization (abortifacient) MOA [mechanisms of action] when it is given during a woman’s fertile period.”