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:
Justices ask if FDA should have continued requirement of reporting mifepristone 'harms'
Justice Samuel Alito asked Jessica Ellsworth, the attorney representing Danco Laboratories, if she thinks the FDA should have continued requiring prescribers to report non-fatal complications, known as “adverse events" of mifepristone.
Ellsworth argued the FDA made that decision after 15 years of data that established mifepristone was safe. She also rejected Alito's question asking if the FDA was "infallible".
Justice Kentanji Brown Jackson asked if the defendants had concerns about judges "parsing medical and scientific studies" and Ellsworth said there were concerns.
Attorney for Danco Labs warns of broader consequences for drug approvals
Jessica Ellsworth, who is representing the manufacturer of Mifeprex (the brand name of mifepristone), similarly criticized the plaintiff's claim of injury and their interpretation of the law.
She said the respondent's view is "so inflexible it would upend not only Mifeprex but virtually every drug approval and [risk and mitigation] modification the FDA has made for decades."
Thomas raises Comstock Act again
With Jessica Ellsworth, representing mifepristone manufacturer Danco Labs, now speaking, Justice Clarence Thomas pressed her on the the 19th-century Comstock Act and why that legislation doesn't bar the use-by-mail of the abortion pill.
Ellsworth responded that Comstock has long not been enforced and that she believes this legal challenge is not an opportunity for the justices to "opine" on Comstock's reach.
The federal government previously said in Tuesday's hearing that they do not believe Comstock's requirements are within the FDA's purview as it regulates drugs.
Ellsworth seemed to echo that during her own presentation and questioning, warning that the justices "should think hard about the mischief" that could be created by requiring FDA regulatory approval to be restricted by provisions beyond safety.
-ABC News' Adam Carlson
Participating counsel are all women
Three women are participating in Tuesday's arguments.
Elizabeth Prelogar, the solicitor general at the Department of Justice, is arguing on behalf of the federal government.
Jessica Ellsworth is representing Danco Labs, the manufacturer of mifepristone.
Erin M. Hawley is counsel speaking for the Alliance for Hippocratic Medicine, a group of anti-abortion medical organizations that brought the challenge against the FDA and mifepristone.
Government gives brief rebuttal as oral arguments come to a close
Solicitor General Elizabeth Prelogar gave a brief rebuttal on behalf of the federal government, summarizing their view that respondents do not have standing and that their sought remedy of nationwide relief is not warranted.
"They have said they fear there will be emergency room doctors somewhere, someday who might be presented with some woman suffering an incredibly rare complication and the doctor may have to provide treatment, notwithstanding the conscience protections," she said.
"We don't think that harm has materialized -- but what the [lower] court did to guard against that very remote risk was issue sweeping nationwide relief that restricts access to mifepristone for every single woman in this country and that causes profound harm," she added. "It harms the agency, which had the courts come in and displace the agency's scientific judgments. It harms the pharmaceutical agency that is sounding alarm bells that this would destabilize the system for approving and regulating drugs. And it harms women who need access to medical abortions under conditions the FDA determined were safe and effective."