Supreme Court hears oral arguments on major abortion pill case

Justices overall appeared skeptical of the challengers of the FDA’s approval of and regulations governing mifepristone, a drug used for medication abortions.

With the caveat that anything can happen, here are the key takeaways from oral arguments:

Read more on the takeaways here.

Jessica Ellsworth, representing Danco, which makes mifepristone, argues before the US Supreme Court in Washington, DC, on March 26.

CNN News Associate Jalen Beckford attended oral arguments at the Supreme Court for the first time. Here are his observations:

Upon arrival at the Supreme Court, members of the press and onlookers were greeted by abortion rights groups marching outside the high court.

“My body, my choice!” they shouted as oral arguments in the case over access to the abortion pill mifepristone were soon underway. 

The courtroom was a stark contrast to the commotion of the protests outside. 

Elizabeth Prelogar, US solicitor general, argues before the US Supreme Court.

I watched as seasoned reporters took notes while holding on to every word uttered by the justices, hoping to get an early prediction of what the court would ultimately decide. Nearly two years after the landmark Dobbs decision that overturned Roe v. Wade, I could feel the weight that this case would have in the national debate over abortion rights. 

A person listens to arguments before the US Supreme Court regarding access to the abortion pill mifepristone.

Sitting next to me, I saw as a courtroom artist caught every detail of the justices and the historical room, making sure to include the red curtains draped behind them and the large columns surrounding the room.

Although reporters are allowed to leave during the hearing, most stayed put as Elizabeth Prelogar argued on behalf of the FDA, Jessica Ellsworth for Danco Laboratories, and Erin Hawley for the Alliance for Hippocratic Medicine. We all watched intently as they fielded questions from the justices regarding their arguments, often interrupted if they didn’t truly answer the question. 

Erin Hawley, senior counsel at Alliance Defending Freedom, argues before the US Supreme Court.

Once we were dismissed, I noticed the crowd seemed to have grown outside the court. I saw signs that read “Bans Off Our Bodies,” and New York Attorney General Letitia James among the onlookers and in support of the protests. 

As organizers stood on the steps of the court, reiterating how consequential a decision would be, their words rang as far as the Capitol.

Both abortion rights and anti-abortion groups march outside the Supreme Court.

Several justices asked questions beyond the law during oral arguments, seeking detailed answers about medical procedures and practices related to reproductive care and mifepristone, one of two drugs used in medication abortion.

Justice Ketanji Brown Jackson sought more information on how often doctors might need to perform emergency procedures for a patient who had taken drugs for a medication abortion, even if the physicians object to abortion.

“It’s my understanding that sometimes, the completion, it doesn’t involve surgical intervention. Do you have a sense of how often?” the liberal justice asked.

Jackson also asked Erin Hawley, an attorney representing the abortion pill’s challengers, how close a doctor might need to be to a procedure they object to in order to be “complicit.”

“Like I — I work in the emergency room and this is going on? I’m handing them a water bottle? I’m — like, what do you mean complicit in the process?” Jackson asked.

At another point, conservative Justice Amy Coney Barrett asked about a dilation and curettage, or D&C, the procedure to remove tissue from the uterus, and noted it did not necessarily mean that a doctor was removing a living embryo, since a D&C can happen after a miscarriage. She also asked specific medical questions about the need for tissue to be removed if an abortion wasn’t complete after a medication.

Barrett also pressed whether the elimination of in-person visits to provide mifepristone — a step the FDA ended in 2023 — would “lead to mistakes in gestational aging, which could increase the need for a D&C or the amount of bleeding.”

Medication abortion is available only through the first 10 weeks of pregnancy. Under current regulations, while a person does not need to see a provider in person to receive drugs for a medication abortion, providers still must be available to assess gestational age and whether someone may have an ectopic pregnancy. Most medication abortions occur without an ultrasound.

Steve Vladeck, CNN Supreme Court analyst and professor at the University of Texas School of Law, has this to say about the injunction discussion:

“One of the issues lurking in this case, and several other before the Court this term, is the uptick in what Justice Neil Gorsuch calls ‘universal’ injunctions—court orders that block state or federal policies as applied to anyone based solely on a claimed injury to a small handful of individuals.

At the very least, the question of when policies should be blocked on a statewide or nationwide basis because a handful of citizens object to them is an issue that should get more discussion—not just from the courts, but from Congress, which has, to this point, been unwilling to provide more guidance for when these kinds of orders should and should not be allowed.”​​

Abortion rights groups march outside the Supreme Court on Tuesday, March 26, in Washington, DC.

Oral arguments have concluded in a major Supreme Court case over access to the commonly used abortion drug mifepristone.

The nine justices heard arguments from three separate attorneys for more than an hour Tuesday morning. A decision in the case is expected by the end of June or early July.

Chief Justice John Roberts and Justice Neil Gorsuch.

Chief Justice John Roberts and Justice Neil Gorsuch have peppered the attorney for the abortion pill challengers why her clients were seeking a nationwide relief in the case as opposed to a narrower remedy that would apply only to the plaintiff doctors.

“Why can’t the court specify that this relief runs to precisely the parties before the court as opposed to looking to the agency in general and saying agency you can’t do this anywhere?” Roberts asked the attorney, Erin Hawley.

For his part, Gorsuch told Hawley that he went back “and looked and there are exactly zero universal injunctions that were issued during Franklin Delano Roosevelt’s 12 years in office.”

“And over the last four years or so, the number is something like 60 and maybe more than that,” he continued.

Justice Ketanji Brown Jackson flipped a question from Justice Samuel Alito on its head to give the US Food and Drug Administration’s defenders an opportunity to argue that the agency is better suited to make calls on medical science than the courts.

Alito had suggested that, according to the arguments of the administration and mifepristone manufacturer, the FDA would be “infallible” to any skepticism of its approach.

Jackson returned to the question while Danco’s attorney, Jessica Ellsworth, was arguing, and asked Ellsworth her concerns about judges “parsing” medical and scientific studies.

Ellsworth pointed to some of the questionable types of “misleading” assertions the lower courts used to justify their second guessing of the agency, including a blog post analyzing anonymous anecdotes and studies that have since been retractions.

Empty boxes of mifepristone pills fill a trash can at Alamo Women's Clinic in Albuquerque, New Mexico, in January 2023.

Congress gave the US Food and Drug Administration the authority to regulate drugs more than 60 years ago, and in 1962 it was also given the authority to require that drug companies prove that the drugs are effective. Mifepristone, one of the drugs used in medication abortion in the US, was initially approved in 2000, but regulations around its use have shifted since then.

For a medicine to be approved by the the FDA, drugmakers needs to meet rigorous standards that show that the drug is safe and effective. They do this through data from lab, pre-clinical and clinical studies.

Here’s a timeline of FDA’s regulations around mifepristone:

2000: Initially, mifepristone was approved for medical termination of pregnancy with several restrictions. It could only be prescribed through seven weeks of gestation and only doctors could prescribe it in-person.

2016: The FDA expanded the use of mifepristone after Danco Laboratories, the drug’s sponsor, submitted additional materials to change the way the drug could be used. The FDA took a closer look at 16 years of data on mifepristone use and took into account the way it was prescribed in other countries, as well as professional organization guidelines. Using data from 20 additional studies that looked at the safety and effectiveness of the drug, the FDA allowed clinicians to prescribe the medicine up to 10 weeks of pregnancy.

2021: Due to the Covid-19 pandemic along with studies looking at the effectiveness and safety of telehealth, the FDA eliminated the in-person dispensing requirement. After additional review of the available safety and effectiveness data, and based on the experience of millions of people who used the drug, the FDA made that change permanent in 2023 and eliminated the in-person dispensing requirement.

Erin Hawley, with Alliance Defending Freedom, exits the federal courthouse on March 15, 2023, in Amarillo, Texas.

Erin Hawley, an attorney representing the abortion pill’s challengers, told the justices that they should undo the the US Food and Drug Administration’s moves in recent years to ease restrictions around the drug, arguing those decisions ran afoul of federal law.

“FDA’s outsourcing of abortion drug harm to respondent doctors forces them to choose between helping a woman with a life-threatening condition and violating their conscience,” she added later.

Hawley is a senior counsel at Alliance Defending Freedom, a conservative advocacy group. She was a law clerk to Chief Justice John Roberts during the same term as her now-husband, Republican Sen. Josh Hawley from Missouri. An experienced advocate who has specialized in anti-abortion litigation, the mifepristone case will mark Hawley’s first appearance at the Supreme Court lectern.

Jessica Ellsworth, an attorney representing Danco, which makes mifepristone, has just begun delivering her arguments in defense of the abortion pill the company manufactures.

Ellsworth is a partner at the Hogan Lovells law firm and has specialized in administrative law disputes. She is a regular practitioner in federal appellate courts, and this case will be her second time at the lectern before the justices.

Justice Samuel Alito said that a long unenforced law banning the mailing of drugs used for illegal abortions was not “obscure” but rather a “prominent” law.

Alito’s reference to the Comstock Act, a 19th century statue outlawing the use of the mail to send various “lewd” materials, is notable. Some anti-abortion activists see the law as an avenue to end medication abortion, and perhaps all kinds of abortion.

The Comstock Act has not been a central part of this case, but the challengers have gotten a little bit of traction at the lower court level with their argument that the FDA acted unlawfully in its approach to mifepristone because it did not take into account to Comstock Act’s criminal prohibitions on mailing drugs used for illegal abortions.

Solicitor General Elizabeth Prelogar countered on Tuesday that it is not the Food and Drug Administration’s job to enforce criminal law, and that the FDA did get advice at the time that from the Justice Department about its interpretation of the law. 

Defenders of the FDA have also argued that the Comstock Act’s prohibitions are geared towards “illegal” abortions, and this case is attempting to limit the access of mifepristone even in places where abortion is legal. 

Justice Clarence Thomas also brought up the Comstock Act in questions for Danco, a mifepristone manufacturer that has intervened to defend the FDA’s regulation. Danco’s attorney said that this case was not an appropriate venue for the court to weigh the reach of the Comstock Act.

The discussion has turned to a key question — if the doctors challenging the nationwide approval of mifepristone can simply have a “conscientious objection” that doesn’t require them to assist in an abortion rather than force a nationwide ban on the drug.

Conservative Justice Brett Kavanaugh asked whether federal law provides some protections for doctors who object to providing an abortion on moral and religious grounds – a sign that he may not be convinced that the plaintiff doctors had the legal right to bring their suit against the FDA.

“Just to confirm on the standing issue: under federal law, no doctors can be forced against their consciences to perform or assist in an abortion, correct?” Kavanaugh – who is sometimes a swing vote on the high court — asked Solicitor General Elizabeth Prelogar.

Prelogar pressed that point to Justices Amy Coney Barrett and Ketanji Brown Jackson as well.

The first 15 minutes of oral arguments have been focused on standing — the legal threshold plaintiffs must overcome by showing they are being harmed in a way to warrant a court’s intervention. 

It’s not a surprise that has been top of mind for the justices, as the standing theories put forward by the US Food and Drug Administration’s opponents have been seen as a very weak part of their case, and experts have warned that blessing those theories would be the door to a flood of lawsuits against the FDA for a variety of drugs by people with ideological opposition to those drugs.

Conservative justices have pressed Solicitor General Elizabeth Prelogar to identify who could sue in the event that the FDA was acting unlawfully in a way that was harming women. 

Liberal Justice Sonia Sotomayor jumped in to float a scenario in which a concerned doctor who prescribed a drug could sue if there was real, measurable evidence that changes to the drug’s regulations were causing harm.

Prelogar has walked the line of arguing that there is a high standard for who could bring this type of lawsuit against the FDA while acknowledging that on some specific scenarios, a court would have the authority to weigh in.

Justice Samuel Alito, who wrote the 2022 decision that overturned Roe v. Wade and the constitutional right to an abortion, is unhappy with the Biden administration’s argument that the doctors don’t have the legal right, or “standing” to sue.

Alito also demanded to know who would have the ability to sue the US Food and Drug Administration in this case.

The fact that Alito is going down this road suggests the conservative justice is searching for ways to allow the lawsuit to proceed.

Chief Justice John Roberts pressed an attorney for the Biden administration on a novel theory of legal “standing” that would allow some individuals to bring a lawsuit like the one at the center of the case if there was a statistical likelihood that they would face the requisite injury required to bring the suit.

Prelogar said the government rejected such a theory.

“We have an objection here to the underlying theory as a legal matter because it rests on so many different things that would have to happen one on top of another and that turn on independent decisions made by third parties who are strangers to this litigation – who are not part of the suit,” she told Roberts.

If the court ultimately says such a theory exists, it would allow their suit to stand, but the court would still need to decide the other issues.

US Solicitor General Elizabeth Prelogar began by going straight to the question of standing — whether the doctors challenging mifepristone have the legal standing to challenge the FDA’s approval.

In response to a question from Justice Clarence Thomas about the people challenging the drug, Prelogar said:

More context: The blockbuster case at the Supreme Court could make it harder for millions of Americans to access the abortion pill mifepristone has turned almost entirely on 11 anti-abortion doctors and advocates who say their work has been upended by patients experiencing complications from the drug.

Most of the doctors directly involved in the case have long records advocating against abortion. None of the doctors who submitted declarations prescribe mifepristone and none have pointed to an instance when they personally were required to perform an abortion for a patient who had complications after taking the drug.

Read more about the doctors challenging mifepristone.

People wait in line outside US Supreme Court to hear oral arguments on March 26, in Washington, DC.

Oral arguments in the abortion pill case kicked off just after 10 a.m. ET Tuesday, with US Solicitor General Elizabeth Prelogar appearing at the lectern in the well of the courtroom to defend the US Food and Drug Administration’s decisions to loosed restrictions around the drug.

Prelogar has been US solicitor general since 2021, appointed by President Joe Biden.

She served as a law clerk to the late Justice Ruth Bader Ginsburg and to still-sitting Justice Elena Kagan. The FDA case will be Prelogar’s 30th argument before the justices.

An abortion using medication, rather than a procedure, is the most common option in the United States.

Nearly two-thirds of all abortions in the US in 2023 — an estimated 642,700 — were medication abortions, according to a March report from Guttmacher Institute, a research and policy organization focused on sexual and reproductive health that supports abortion rights.

This option has become steadily more common over the past two decades, rising from less than 10% of all abortions in the US in 2001 to 53% in 2020 and 63% in 2023.

From its FDA approval in 2000 to 2016, the last year for which data was available, more than 2.75 million women in the US used mifepristone for an abortion, according to Danco Laboratories, a company that distributes the drug. 

The pills can be obtained in person from a provider or through telehealth in states where the practice is not banned.

US solicitor general Elizabeth Prelogar, attorney Jessica Ellsworth and attorney Erin Hawley.

The three lawyers appearing before the justices today have a variety of experience in the legal field and at the Supreme Court.

Elizabeth Prelogar has been US solicitor general since 2021, appointed by President Joe Biden. She served as a law clerk to the late Justice Ruth Bader Ginsburg and to still-sitting Justice Elena Kagan.

The FDA case will be Prelogar’s 30th argument before the justices.

Jessica Ellsworth, representing Danco, which makes mifepristone, is a partner at the Hogan Lovells law firm and has specialized in administrative law disputes. Ellsworth is a regular practitioner in federal appellate courts, and this case will be her second time at the lectern before the justices.

Erin Hawley is a senior counsel at Alliance Defending Freedom, a conservative advocacy group. She was a law clerk to Chief Justice John Roberts, during the same term as her now-husband, Missouri Republican Sen. Josh Hawley.

An experienced advocate who has specialized in anti-abortion litigation, the mifepristone case will mark Hawley’s first appearance at the Supreme Court lectern.

The US Supreme Court will hear arguments soon on a case that could curtail access to mifepristone, one of two drugs used in medication abortion.

Mifepristone was approved by the US Food and Drug Administration decades ago and has been shown to be safe and effective. But anti-abortion advocates have claimed that the drug is not safe and that the FDA didn’t study it enough to approve it.

How mifepristone works: Along with misoprostol, mifepristone is one of the drugs used for an abortion via medication, as opposed to surgery. Mifepristone is marketed under the brand names Mifeprex and Korlym, and it’s sometimes known as RU-486. Mifepristone blocks a hormone called progesterone, which helps the body maintain the inside of the uterus so a pregnancy can continue. A healthy uterine lining is what supports a fertilized egg, embryo and fetus. Without progesterone, the uterus will expel its contents.

Someone having a medication abortion takes mifepristone and then, after 24 to 48 hours, takes misoprostol. That drug helps empty the uterus through heavy bleeding and muscle contractions. The medications can be taken as soon as someone learns that they are pregnant and up to 70 days or less since the first day of their last period. This method is effective 99.6% of the time when used to end a pregnancy, studies show.

How safe is mifepristone? Data from hundreds of studies and 23 years of approved use has shown that mifepristone is highly safe and effective, according to 12 of the country’s most respected medical associations, including the American College of Obstetricians and Gynecologists and the American Medical Association, that signed an amicus brief in the Texas case.

How often is mifepristone used? The mifepristone-misoprostol combination is the most common abortion method in the US. Data from the Guttmacher Institute, a research and policy organization focused on sexual and reproductive health that supports abortion rights, shows that this option has become steadily more common over the two decades it’s been available, rising from less than 10% of all abortions in the US in 2001 to 53% in 2020 and 63% in 2023.

Read more about the abortion drug.