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.
Pelogar, in her opening statement, contended the anti-abortion plaintiffs have no standing and defended the FDA's approval of the drug.
She warned that the relief sought by the Alliance for Hippocratic Medicine would both "severely disrupt the federal system for developing and approving drugs" and "inflict grave harm on women across the nation."
Oral arguments have begun over the abortion pill mifepristone and whether the FDA lawfully relaxed restrictions on the drug to make it easier to access to end a pregnancy.
Solicitor General Elizabeth Prelogar will be the first to give an opening statement.
With arguments set to begin shortly, there are large competing demonstrations outside the building.
Small groups of pro-abortion rights demonstrators were staging sit-ins on sidewalks and roadways.
There is a heavy police presence and Capitol Police are conducting some arrests.
The lead plaintiff, the Alliance for Hippocratic Medicine, had initially challenged the FDA’s approval of mifepristone.
But the matter before the high court now is more narrow -- whether the FDA's subsequent regulatory decisions about the drug, in 2016 and 2021, were sound.
In court filings, the Alliance Defending Freedom, a Christian conservative legal advocacy representing the plaintiffs, has claimed mifepristone is not safe and that the FDA didn't study it closely enough before it was approved.
The group also argued that the FDA’s decisions in 2016, lowering the recommended dosage and extending the use from seven weeks through 10 weeks of pregnancy, and in 2021, which permanently lifted the restriction on requiring abortion pills to be dispensed in-person, were unsound.
In January 2022, the FDA went further by allowing retail pharmacies to provide the drug too, either by mail or in person, so long as they meet certain requirements, which the plaintiffs claim violate federal laws that prohibit the distribution of chemical abortion drugs by mail.
The FDA rejects the claims, arguing that mifepristone is safe when used as indicated and directed, and that the pill went through a thorough and comprehensive review before being approved.
