Barrett questions possible increase in complications due to telemedicine
Justice Amy Coney Barrett questioned Prelogar on whether a lack of ultrasound before prescribing mifepristone could increase complications. Prelogar responded that even before telemedicine consultations were allowed for prescribing mifepristone, most women received the pill without one and that there was not an associated rise in complications.
Kagan asks if this is the only time a court has overridden FDA judgment
Justice Elena Kagan asked if the Texas decision was the first time a court has overridden a judgment by the FDA.
Prelogar says she thinks so and argues courts have no business making those judgments.
What is the Comstock Act?
Justice Samuel Alito just questioned Prelogar about the Comstock Act, a 151-year-old law that prevents using the mail to send "obscene" materials.
This law has been used as part of the challenge to newer FDA regulations that allow mifepristone to be mailed to patients. Parts of the bill have been repealed, but the prohibition on abortion materials being mailed still stands.
Alito asks about three changes involving mifepristone making it more dangerous when taken together
Alito asked Prelogar if three changes the government made to the access of mifepristone make the drug's risks higher when taken together. Under the new guidance, patients only need one doctor visit versus three to obtain the drug. The guidance also allows patients up to 10 weeks gestation to take the drug and they're able to access the drug by mail.
"You say that the 5th Circuit didn't give any reason to think that the three changes made in 2016 would be more dangerous in combination than they were individually. But isn't that obvious?" Alito asked. "That three things that may be innocuous or not excessively dangerous, if engaged in by themselves may become very dangerous, when they're all done together?"
Prelogar said the only way that would be true "would be if the three changes are interconnected and mutually reinforcing, guarding against the same kind of safety risk."
"So I agree that if there were a reason to think that the reason why mifepristone is safe up to 10 weeks gestation is because it's being prescribed by doctors instead of nurse practitioners, for example, then those changes would be interconnected," she said.
She added, "But there was nothing like that in this record. The studies that FDA examined instead demonstrated that these changes — and it was an exhaustive examination — were safe, not because there were other different safeguards in place to guard against risks, but rather because if you go up to 10 weeks of gestation, there is no observable increase in serious adverse events, no matter who's prescribing."
Medication abortions spiked last year
Medication abortions accounted for nearly two-thirds of all abortions in the formal U.S. health care system in 2023, according to a recent report from the Guttmacher Institute, which advocates for abortion access. That's a 30% increase since 2020, when abortion pills made up 53% of the overall total.
The provision of medications for self-managed abortions outside the formal health care system also increased in the six months after the Supreme Court overturned Roe v. Wade, according to a study published Monday. From July to December 2022, there were an additional 27,800 instances of medication being provided for self-managed abortions compared to what was expected before Roe was reversed, the researchers estimated.
Solicitor general argues conscience protections would continue to apply for individual doctors who don’t want to provide care
Prelogar said the petitioners don’t think the federal Emergency Medical Treatment and Active Labor Act (EMTALA) would override conscientious protections for an individual doctor. She also noted that hospitals have a series of contingency plans in place such as staffing plans.
Prelogar acknowledged that as a matter of best practices, doctors are often asked to articulate their conscientious objections in advance so that it can be taken into account.
A smaller group of anti-abortion protesters gather outside the court
The protesters outside the court are mainly supportive of abortion access, but there are smaller groups of anti-abortion protesters.
The issue of standing is first up in questioning
Questioning has begun and Justice Clarence Thomas has begun with questions about standing. Standing refers to whether or not the group challenging the law actually faces harm from it and thus can sue.
The government is arguing that the physician group suing the FDA does not have standing, saying that "their theories rely on a long chain of remote contingencies." The Alliance for Hippocratic Medicine has argued that physicians could potentially be harmed if they had to treat a patient who had adverse health effects from mifepristone.
Questions from the judges then focused on who would be able to sue if these groups could not. The government had a hard time coming up with a party that would have standing in this case.
Solicitor general warns of consequences of restricting mifepristone access
Prelogar argued in her opening remarks that if the Supreme Court rules in favor of plaintiffs and, as a result, restricts access to mifepristone, it would have profoundly negative effects on people.
She said it would "severely disrupt the federal system for developing and approving drugs," adding that it would harm the FDA and the pharmaceutical industry.
"It would also inflict grave harm on women across the nation," she said. "Rolling back FDA changes would unnecessarily restrict access to mifepristone with no safety justification. Some women could be forced to undergo more invasive surgical abortions. Others might not be able to access the drug at all."
She said the court "should reject that profoundly inequitable result."
Where is medication abortion legal right now?
Access to the two drugs involved in a medication abortion is legal in some form in 36 states and Washington, D.C., according to data from the Guttmacher Institute, a research organization that advocates for abortion access.
But 15 states limit who can prescribe medication abortions, and two states — Arizona and North Carolina — ban the mailing of abortion pills. Arizona, Nebraska, North Carolina, South Carolina and Wisconsin also require an in-person visit with a physician before the pills can be prescribed.