In abortion pill hearing, Supreme Court sounds skeptical of challenge to mifepristone access
It's the first major abortion rights case since Roe was overruled.
A high-stakes hearing played out before the U.S. Supreme Court on Tuesday in a case that could reshape abortion access nationwide.
The justices considered a challenge to the Food and Drug Administration’s regulation of mifepristone, the first pill taken in a two-drug regimen for a medication abortion, which is the most common method of abortion in the country.
It is the first major reproductive rights case before the high court since Roe v. Wade was overturned in 2022. A decision is expected by the end of June.
Key moments:
What's at stake
Experts say the Supreme Court's decision could result in limits on the drug even in states where abortion is legal. It could restrict the ability to mail abortion medication to patients living in states with bans in effect and require that the drug be provided in-person, as well as change how many weeks into pregnancy the pill could be used.
The case could also have broader consequences for the FDA's regulatory authority over other drugs.
More than half of all abortions in the U.S. are done via medication, according to from the Guttmacher Institute, which supports abortion access, and the utilization of medication abortions has steadily increased over the last two decades.
How we got here
Medication abortion quickly became the target of multiple lawsuits after the Supreme Court struck down Roe's guarantees to national abortion access.
Last year, U.S. District Judge Matthew Kacsmaryk in Texas issued an unprecedented ruling suspending the FDA's initial approval of the drug (which has been on the market for nearly 25 years) because, he said, the drug was unsafe and its approval process rushed.
Kacsmaryk's order was partially blocked by the 5th U.S. Circuit Court of Appeals, though that court held the FDA acted unlawfully when it eased rules in 2016 and 2021 to allow the pill to be mailed to patients, prescribed by a medical professional and taken later in pregnancy.
The Biden administration then appealed to the U.S. Supreme Court, warning the loss of access would be "damaging for women and healthcare providers" nationwide and defending the FDA's process as supported by science and decades of safe use.
Attorney notes some studies in initial ruling were retracted
Jessica Ellsworth, the attorney for Danco Labs, was asked by Justice Ketanji Brown Jackson if she was concerned about the prospect of judges parsing medical and scientific studies without specialized knowledge.
"I think we have significant concerns about that," Ellsworth said, noting the pharmaceutical industry submitted briefs to the court expressing that worry.
She went on to state that U.S. District Judge Matthew Kacsmaryk, who initially ruled to suspend mifepristone's approval, relied on studies that "were not in the administrative record" and never would have been.
"They have since been retracted for lack of scientific rigor and misleading presentations of data," she said.
Sage Publishing said it issued the retractions from the journal Health Services Research and Managerial Epidemiology because of methodology issues and conflicts of interest, ABC News previously reported.