The Supreme Court fight over an abortion pill: What's next?
A look at what’s next for mifepristone, the first abortion-related case the court has taken since a majority of the current justices struck down the constitutional right to abortion in 2022.
Introduction
U.S. Supreme Court justices on March 26 did not appear ready to limit access to the abortion pill mifepristone, in a case that could have far-reaching implications for millions of American women and for scores of drugs regulated by the Food and Drug Administration.
It's the first abortion-related case the court has taken since a majority of the current justices struck down the constitutional right to abortion in 2022.
A group of anti-abortion doctors had asked the court to restrict access to mifepristone and to limit when in a pregnancy it could be used.
Key moments from the arguments:
What is mifepristone?
Mifepristone was approved for use by the Food and Drug Administration more than two decades ago. It has been used by more than 5 million women to safely end their pregnancies, and today more than half of women who end a pregnancy rely on the drug, the Justice Department said.
Over the years, the FDA has loosened restrictions on the drug's use, extending from seven to 10 weeks of pregnancy when it can be used, reducing the dosage needed to safely end a pregnancy, eliminating the requirement to visit a doctor in person to get it and allowing pills to be obtained by mail. The FDA also approved a generic version of mifepristone that its manufacturer, Las Vegas-based GenBioPro, says makes up two-thirds of the domestic market.
Mifepristone is one of two pills used in medication abortions, along with misoprostol. Health care providers have said they could switch to misoprostol only if mifepristone is no longer available or is too hard to obtain. Misoprostol is somewhat less effective in ending pregnancies.
Is mifepristone safe?
Pictured: An abortion-rights activist holds a box of mifepristone pills as demonstrators from both anti-abortion and abortion-rights groups rally March 26, 2024, outside the Supreme Court.
Legal briefs filed with the Supreme Court describe the pill's safety in vastly different terms: Medical professionals call it “among the safest medications” ever approved by the FDA, while the Christian conservative group suing the agency attributes “tens of thousands” of “emergency complications” to the drug.
Earlier this year, a medical journal retracted two studies that claimed to show the harms of mifepristone. The studies were cited in the pivotal Texas court ruling that brought the matter before the Supreme Court. The publisher cited conflicts of interest by the authors and flaws in their research, although the studies' lead author called the retractions a baseless attack.
Mifepristone is typically used with misoprostol in a medication abortion.
There are rare occasions when mifepristone can cause dangerous, excessive bleeding that requires emergency care. Because of that, the FDA imposed strict safety limits on who could prescribe and distribute it — only specially certified physicians and only as part of three mandatory in-person appointments with the patient getting the drug.
The doctors also had to be capable of performing emergency surgery to stop excess bleeding and an abortion procedure if the drug didn't end the pregnancy.
Abortion opponents say the more lax restrictions resulted in many more “emergency complications.” But that argument lumps together women experiencing a range of issues with mifepristone — from the drug not working to people who may simply have questions or concerns but don’t require medical care.
OB-GYNs say a tiny fraction of patients suffer “major” or “serious” adverse events after taking mifepristone.
A legal brief by a group of medical organizations including the American College of Obstetricians and Gynecologists says: “When used in medication abortion, major adverse events — significant infection, excessive blood loss, or hospitalization — occur in less than 0.32% of patients, according to a highly regarded study with more than 50,000 patients.”
The definition that scientists generally use for serious adverse events includes blood transfusions, major surgery, hospital admissions and death, said Ushma Upadhyay, one of the authors of that 2015 study. She added: “The hospital admission is a catch-all for the very serious but more rare events such as major infection.”
The prescribing information included in the packaging for mifepristone tablets lists slightly different statistics for what it calls “serious adverse reactions.” It cites ranges for how frequently various complications occur: 0.03% to 0.5% for transfusion; 0.2% for sepsis and 0.04% to 0.6% for hospitalization related to medication abortions. The ranges reflect findings across various relevant studies, experts said.
How did the case get started?
A lawsuit over mifepristone was filed in Amarillo, Texas, in late 2022. Alliance Defending Freedom, a conservative Christian legal group, represents the pill's opponents, who say the FDA's approval of mifepristone was flawed.
Why Amarillo? U.S. District Judge Matthew Kacsmaryk (pictured), who was nominated by then-President Donald Trump, is the sole district court judge there, ensuring that all cases filed in the west Texas city land in front of him. Since taking the bench, he has ruled against President Joe Biden's administration on several other issues, including immigration and LGBTQ protections.
On April 7, 2023, Kacsmaryk issued a ruling that would revoke the FDA's approval of mifepristone, but he put the decision on hold to allow an appeal.
Complicating matters, however, on the same day Kacsmaryk issued his order, a court in Washington state issued a separate ruling in a lawsuit brought by liberal states seeking to preserve access to mifepristone. The Washington judge, Spokane-based Thomas O. Rice, whom then-President Barack Obama nominated, ordered the FDA not to do anything that might affect the availability of mifepristone in the suing states. The Biden administration has said it is impossible to follow both judges' directives at the same time.
How did the case get to the Supreme Court?
The Biden administration argued that the plaintiffs — a group called the Alliance for Hippocratic Medicine — didn't have the right to challenge the FDA's actions on mifepristone.
The doctors who brought the suit argued that they might have to treat emergency room patients who experience serious complications after taking the drug.
But Solicitor General Elizabeth Prelogar told the court that the doctors don't have to prescribe mifepristone and they can abstain from treating patients who have taken the pill if they oppose abortion.
“They don’t prescribe mifepristone,” Prelogar said. "They don’t take mifepristone, obviously. The FDA is not requiring them to do or refrain from doing anything. They aren’t required to treat women who take mifepristone.”
Justice Samuel Alito, however, repeatedly pressed the government on who did have the right to sue over FDA's decisions.
“Is there anybody who can sue and get a judicial ruling on whether what FDA did was lawful?” Alito, who wrote the 2022 ruling that overturned Roe v. Wade, asked.
About the photo: Laura Meyers, CEO of Planned Parenthood Metropolitan Washington DC, speaks during a Planned Parenthood rally in support of abortion access outside the Supreme Court on Saturday, April. 15, 2023, in Washington.
What could happen next?
The Supreme Court on March 26 seemed likely to preserve access to a medication that was used in nearly two-thirds of all abortions in the U.S. last year, in the court’s first abortion case since conservative justices overturned Roe v. Wade two years ago.
In nearly 90 minutes of arguments, a consensus appeared to emerge that the abortion opponents who challenged the FDA's approval of the medication, mifepristone, and subsequent actions to ease access to it, lack the legal right or standing to sue.
Such a decision would leave in place the current rules that allow patients to receive the drug through the mail, without any need for an in-person visit with a doctor, and to take the medication to induce an abortion through 10 weeks of pregnancy. Should the court take the no-standing route, it would avoid the more politically sensitive aspects of the case.
The high court’s return to the abortion thicket is taking place in a political and regulatory landscape that was reshaped by its abortion decision in 2022 that led many Republican-led states to ban or severely restrict abortion.
Solicitor General Elizabeth Prelogar, the Biden administration’s top Supreme Court lawyer, said the court should dismiss the case and make clear that anti-abortion doctors and organizations don’t “come within 100 miles” of having standing.
Even three justices who were in the majority to overturn Roe posed skeptical questions about standing to the lawyer for the abortion opponents. Justices Amy Coney Barrett, Neil Gorsuch and Brett Kavanaugh are former President Donald Trump’s three Supreme Court appointees.
Another abortion case already is on the docket. In April, the justices will hear arguments over whether a federal law on emergency treatment at hospitals must include abortions, even in states that have otherwise banned them.
A closer look
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