Medicinal abortion being challenged in the American Supreme Court
The United States Supreme Court on 13th December 2023 accepted to consider an appeal in order to re-establish restrictions on the use of Mifepristone, the product used for medicinal abortions.
The case initiated in Texas with an appeal by the Alliance for Hippocratic Medicine association. The latter claimed that the authorisation for marketing of Mifepristone had been improperly delivered by the FDA (Food & Drug administration) in 2000. The procedure for deliverance of the product, also known in France under the name RU 486, was subsequently modified several times in particular in 2016 and again in 2021.
A product subject to special requirements
Mifepristone is used in combination with another product, misoprostol, which is taken 48h later to induce expulsion of the foetus. Abortion by the combination of these two products represents more than 50% of abortions in the USA (76% of abortions in France). It may be conducted in hospital or at home.
Mifepristone belongs to the list of pharmaceutical products subject to special requirements, as is the case in France, due to sanitary and safety problems and due to the irreversibility of abortion. The product must be delivered directly to the person (“dispensation in person requirement”) by a certified medical prescriber and is only available through certified chemists.
The FDA requirements associated with deliverance are multiple:
- Check of the dating of the pregnancy,
- Check that it is not an extra uterine pregnancy
- Have the ability to perform a surgical operation in the event of an incomplete abortion or severe haemorrhage, and ensure access for patients to medical installations equipped for blood transfusions.
Women are informed of the possible serious consequences which could result from this type of abortion even if they are rare, notably severe haemorrhage. Indeed, medicinal abortion may in some cases lead to complications especially as they can be conducted at home, away from any medical facilities.
The modifications to the procedures for the deliverance of Mifepristone
Initially authorised for use up to 7 weeks pregnant, its use was extended in 2016 to abortions at up to 10 weeks pregnant. As a comparison, in France medicinal abortions may be conducted in hospital environments or at home only up to 7 weeks pregnant. Since 2021, the obligation for “dispensation in person” has been deleted with the possibility of obtaining the product by post.
The first judgement suspended deliverance of the product in Texas. Then the Court of Appeals following an appeal by the FDA and the Danco company which markets the product, authorised deliverance of the product but more restrictively according to the pre-2016 conditions, up to 7 weeks pregnant.
The FDA and Danco then appealed against that decision to the Supreme Court in April 2023. In the first instance, the Supreme Court decided to maintain the marketing of Mifepristone under its current conditions, including its deliverance by post, whilst accepting to consider the appeal.
The decision by the Supreme Court should not involve the marketing conditions for 2000 but rather the modification of the rules for deliverance with regard to the sanitary safety requirements. Their decision should be forthcoming within a few months before the end of their yearly session, in June 2024.
