Sunday, December 25, 2022

FDA Approves Label Change for Plan B Emergency Contraceptive: Not an Abortifacient

The U.S. Food and Drug Administration announced on Friday that it has approved a labeling change for the emergency contraceptive Plan B One-Step, sometimes known as the morning-after pill.  The labeling change states clearly that the medication is not an abortifacient.  The FDA says in part:

Plan B One-Step will not work if a person is already pregnant, meaning it will not affect an existing pregnancy. Plan B One-Step prevents pregnancy by acting on ovulation, which occurs well before implantation. Evidence does not support that the drug affects implantation or maintenance of a pregnancy after implantation, therefore it does not terminate a pregnancy.

The original label had been required to say in part: "this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation)."

The FDA supports its conclusion that it does not affect implantation with a detailed Decisional Memorandum discussing more recent studies of the drug.

In the extensive litigation challenging rules under the Affordable Care Act that mandated health insurance policies cover contraceptive methods for women, religious objectors had pointed to Plan B as one of the medications that they considered an abortifacient because it could prevent implantation of a fertilized egg.  Also, since the Supreme Court's Dobbs case, abortion bans in some states might possibly be broad enough to cover medication that prevents implantation.

In a 2015 Memorandum, relying on research available at that time, the Catholic Medical Association rejected the use of Plan B even after a rape. AP reports on the FDA's approval of the labeling change.