SCOTUSblog By Amy Howe
Since the Supreme Court overturned the constitutional right to an abortion in 2022, 14 states have enforced total bans on abortion and seven have imposed previously unconstitutional restrictions. On Tuesday, the justices will hear arguments in a case seeking to roll back access to mifepristone, the drug used in medication abortions, which account for more than half of all abortions in the United States. The court’s ruling could affect the availability of the drug nationwide, including in the states where abortion remains legal.
The drug at the center of the case is known by the generic name mifepristone. It was first approved by the Food and Drug Administration in 2000 as part of a two-drug protocol (along with the drug misoprostol) to end pregnancies in their early stages.
When it initially approved the drug, the FDA imposed a variety of conditions on how the drug could be prescribed and used. The agency required, for example, the drug to be dispensed in person by a doctor, and only through the seventh week of pregnancy. Women taking mifepristone had to make three visits to a health-care provider: A first visit to take mifepristone; a second visit two days later to take misoprostol; and a third visit two weeks after the initial visit to confirm that the pregnancy had been terminated.
In 2016, the FDA made several changes to the conditions on the use of the drug that expanded access to mifepristone. It allowed the drug to be used through the 10th week of pregnancy, required only one in-person visit to a health-care provider, and permitted health-care providers who are not physicians to prescribe the drug.
The FDA in 2016 also eliminated the requirement for prescribers of mifepristone to report non-fatal complications (known as “adverse events”) resulting from the drug, leading to – for example – hospitalizations and blood transfusions. Mifepristone has been proven to be less dangerous than other common medications, with five deaths per million users compared to, for example, 20 and 49 deaths per million users for penicillin and Viagra.
In 2021, the FDA rolled back the in-person dispensing requirement, allowing the drug to be prescribed through telehealth appointments and sent through the mail.
Background of the case
In 2022, several individual doctors and four groups of doctors who oppose abortion on religious and moral grounds went to federal court to challenge both the initial approval of mifepristone and the 2016 and 2021 changes that expanded access to the drug. They alleged that the drug regimen was “unsafe.”
The challengers filed their lawsuit in Amarillo, Tex., where it was all but certain to be heard by Matthew Kacsmaryk, a conservative federal jurist there who, before becoming a judge, had written articles criticizing the court’s landmark decision in Roe v. Wade, establishing the constitutional right to an abortion. (The Judicial Conference of the United States, which makes policy for federal courts, recently announced a new policy intended to crack down on this type of “judge-shopping.”)
In April 2023, Kacsmaryk found that the FDA had approved the drug despite “legitimate safety concerns.” Under his ruling, the drug would not have been available at all: He suspended both the FDA’s initial approval of the drug in 2000 and its later changes to the conditions on the use of the drug…
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