Mifepristone, the primary medication in a medical abortion, is ready for a patient at Alamo Women’s Clinic in Carbondale, Illinois, April 20, 2023.
Evelyn Hockstein | Reuters
The Supreme Court on Wednesday took up a high-stakes legal battle that could lead on to a definitive decision on whether the drug mostly used for medication abortions will proceed to be easily available, including by mail.
The court agreed to weigh appeals from the Biden administration and drug-maker Danco defending several Food and Drug Administration decisions that made it easier to access and use the mifepristone pill. Danco makes the brand version of the pill, Mifeprex.
The justices will hear oral arguments early next 12 months, with a ruling due by the top of June.
The court, which has a 6-3 conservative majority, has previously shown hostility to abortion rights, overturning the landmark abortion rights ruling Roe v. Wade last 12 months. But in April, in an earlier stage of the litigation, the court blocked a judge’s ruling that may have completely invalidated the FDA’s approval of the drug.
The abortion pill dispute does in a roundabout way address any right to abortion, focusing as an alternative on different legal issues in regards to the FDA’s process for approving drugs, however the case raised questions over the court’s pledge last 12 months to depart abortion policy to the states and the federal government.
The FDA’s original decision in 2000 to approve the drug shouldn’t be at issue within the Supreme Court, with the court turning away a separate appeal raising that issue.
The court will as an alternative deal with later FDA actions from 2016 onward that made it easier to access the pill, including the initial 2021 decision that made it available by mail, which was finalized earlier this 12 months.
Also under review are the 2016 decisions to increase the window wherein mifepristone might be used to terminate pregnancies from seven weeks’ gestation to 10 weeks and reduce the variety of in-person visits patients from three to at least one. In one other 2016 move, the FDA altered the dosing regimen, finding that a lower dose of mifepristone was sufficient.
One other way the court could eliminate the case can be to conclude that the challengers don’t have legal standing to bring their lawsuit.
In 2019, the FDA approved a generic type of the drug, which is made by GenBioPro, although that issue shouldn’t be at issue on the Supreme Court.
The Recent Orleans-based fifth U.S. Circuit Court of Appeals in August ruled that the post-2016 FDA decisions must be placed on hold since the moves “were taken without sufficient consideration of the results those changes would have on patients.” The court ruled against the challengers on their efforts to overturn the unique approval of the drug and the later decision to authorize the generic version.
Each side then filed appeals on the Supreme Court.
Demonstrators rally in support of abortion rights on the US Supreme Court in Washington, DC, April 15, 2023.
Andrew Caballero-Reynolds | AFP | Getty Images
The present fight over the drug dates to a November 2022 lawsuit filed by a gaggle of doctors and other medical professionals represented by the conservative Christian legal group Alliance Defending Freedom. They claim that the FDA’s 2000 approval was flawed, as were later decisions that made the drug easier to access, partly because they didn’t keep in mind safety risks to women.
In a sweeping decision, Texas-based U.S. District Judge Matthew Kacsmaryk in April invalidated the FDA’s original approval of the drug from greater than 20 years ago. After the Supreme Court put that call on hold while litigation continued, the appeals court narrowed the scope of Kacsmaryk’s ruling, specializing in the post-2016 changes.
The FDA-approved regimen for a medicine abortion involves two drugs: mifepristone, which blocks the hormone progesterone, and misoprostol, which induces contractions. A majority of abortions within the U.S. are carried out using the pills, in keeping with a survey conducted by the Guttmacher Institute, a research group that supports abortion right.
Access to medication abortion, especially by mail, has develop into of major importance in light of the Supreme Court ruling that overturned Roe v. Wade, which has led to conservative states enacting tough restrictions that either limit or ban abortion outright. Fourteen states currently have total abortion bans, in keeping with Guttmacher.