The U.S. Supreme Court is expected to decide Friday whether to allow lower courts’ restrictions on a medication abortion pill to take effect while legal challenges to its approval more than two decades ago play out.
So what would that mean for California, a state where two out of three voters in November approved a state constitutional amendment declaring abortion a right and where Gov. Gavin Newsom has championed abortion access?
Q: What is the dispute about?
A: A coalition of anti-abortion medical practitioners are challenging the Food and Drug Administration’s approval of mifepristone, a key drug in medication abortions — at 54%, the most common method of abortion in the U.S.
A U.S. District Court judge in Amarillo, Texas, halted the FDA’s approval of the drug on April 7. The U.S. Department of Justice asked the 5th Circuit U.S. Court of Appeals in New Orleans to put that decision on hold while the case proceeds. The appellate court April 12 allowed the FDA’s original approval of mifepristone to stand while the case plays out but blocked more recent FDA changes that made the drug easier to get. The U.S. Supreme Court is being asked to review that order and put off its decision until Friday night.
Q: If the Supreme Court allows the partial stay to stand while the lawsuit proceeds, how will that change access in California?
A: Access to mifepristone in the U.S. would revert to FDA rules governing its use before 2016 while the litigation continues. That means it could only be used to end pregnancies up to seven weeks, would require three in-person medical office visits and supervision by a qualified physician who would have to report any complications.
Q: What changes since 2016 would be suspended?
A: In 2016, the FDA extended approval for mifepristone to 10 weeks of gestation, allowed non-doctors to prescribe and administer the drug and eliminated the requirement to report complications that aren’t fatal. The FDA in 2019 approved a generic version of the drug and earlier this year removed the in-person dispensing requirement, allowing the drug to be distributed by mail.
Q: Why did the appellate court grant a partial stay?
A: Opponents in 2002 challenged the FDA’s initial approval of mifepristone. The FDA denied that challenge in 2016. Opponents then filed a lawsuit over subsequent FDA decisions that expanded the use and access of mifepristone. The appellate court said that “it appears that the statute of limitations” bars challenges to the FDA’s 2000 approval of mifepristone but that challenges to FDA decisions in 2016 and later “are timely.”
Q: I heard California and other states are stockpiling abortion pills. Would that be affected by Friday’s court ruling?
A: Earlier this month, Newsom announced that California has stockpiled 250,560 abortion pills and negotiated a contract for up to 2 million more. But those aren’t the same pills involved in the court decision. Medication abortion typically involves use of mifepristone followed by a second drug, misoprostol, which is used to prevent ulcers but also can cause contractions of the womb. Misoprostol’s approval isn’t at issue in the case, and because it is cheaper and more widely available than mifepristone, abortion-rights advocates have seen its use alone as a suitable alternative.
Q: If misoprostol works and isn’t in legal jeopardy, why not just use that?
A: Studies have found that first-trimester medication abortions using only misoprostol are safe though not as effective as when used in combination with mifepristone. Studies show the two-drug regimen to be 95-98% effective, while a recent study on using misoprostol alone found it 88% effective, and others have put the figure closer to 80%. That can mean more pills or surgery to complete the abortion and more severe side effects.
NARAL Pro-Choice California Director Shannon Olivieri Hovis said that the two-drug combination is the most effective, with fewer complications, and that “providers want to ensure this is as easy and painless as possible for someone going through medication abortion.”
Q: Should the stockpiled pills be needed, will there be enough?
A: The state’s current stockpile of 250,000 pills would provide for an estimated 12,000 abortions using only misoprostol. But it is there to provide backup for providers who already have their own supplies in stock to ensure they don’t run into shortages, which aren’t expected.
Q: What else is California doing to ensure access?
A: Newsom on Tuesday said he and fellow Democrats in the legislature aim to protect California pharmacists’ dispensing mifepristone even if the Supreme Court suspends the drug’s FDA approval and prevent any legal or licensing actions against those who manufacture, transport, store or dispense the drug. They also plan to ensure patients’ and providers’ privacy over reproductive procedures performed in California, including for patients who travel or live out of state.
But the governor and lawmakers provided no details or new bills. Newsom told reporters who asked whether that meant the state would defy a court ruling on abortion pills that the state will abide by federal law but declined to elaborate.
Q: Would this affect surgical abortion?
A: The court case only involves a drug used in medication abortion. Surgical abortion would remain available in California, but demand could increase if women find medication abortion harder to obtain.
Q: How long will the current rules remain in effect?
A: The Supreme Court has put the lower court ruling on hold until at least 11:59 p.m. eastern time Friday, or 9 p.m. on the West Coast, while it considers a request to maintain current rules until the case is resolved.
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