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.
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.
Mifepristone is a drug typically used in combination with another drug, misoprostol, to induce an abortion or to help manage an early miscarriage.
The medication works by blocking progesterone, a hormone that the body needs to continue a pregnancy.
This causes the uterine lining to stop thickening and to break down, detaching the embryo. The second drug, misoprostol, taken 24 to 48 hours later, causes the uterus to contract and dilates the cervix, which will expel the embryo.
However, the World Health Organization says the two drug-regiment can be taken up until the 12-week mark of pregnancy.
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.
