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.

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. 

Inside the court, “silence” is expected. In the section designated for press, no phones or laptops are allowed, and most reporters resorted to the more traditional pen and pad for their notes. 

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. 

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. 

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.

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.

We’ve seen these kinds of injunctions become much more prevalent over the past decade—against both Republican and Democratic policies. And although the Court has yet to rein them in directly, Justice Gorsuch has, as he did in today’s arguments, repeatedly suggested that the justices ought to do so.

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.”​​

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 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.

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, 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.

“Is there anybody who can sue and get a judicial ruling on whether what FDA did was lawful? And maybe what they did was perfectly lawful. But shouldn’t somebody be able to challenge that in court?” he asked.

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.

“Is there a number of which your argument would change the significant number of consequences – a higher likelihood of an emergency room visit? Doctors who spend more time in the emergency room at some point. Does this analysis lead to the other result?” Roberts asked Solicitor General Elizabeth Prelogar.

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:

“Obviously FDA is not requiring them to do or refrain from doing anything. They aren’t required to treat women who take note mifeprestone. FDA is not directing the women who take the drug to go seek out care from these specific doctors, and so they stand at a far distance from the upstream regulatory action they’re challenging”

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.

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.

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.

Ahead of today’s high-stakes Supreme Court oral arguments, activists for and against the abortion drug are gathering outside the building to express their opinions about the issue.

Here’s a look at the scene outside of the Supreme Court:

No matter the status of mifepristone, misoprostol, the second drug used in a medical abortion, would still be available and could be used on its own. It comes as the Supreme Court considers restrictions for the abortion drug during oral arguments on Tuesday.

The US Food and Drug Administration has only approved misoprostol for preventing and treating gastric ulcers. But some doctors use it “off-label” by itself for an abortion. It can also have other off-label obstetric or gynecologic uses such as inducing labor.

Studies show that misoprostol alone is effective and safe for an abortion and is a “reasonable” option for people who want an abortion in the first trimester, according to a 2019 review of multiple studies, but the two-drug regimen is considered more effective.

People who take misoprostol on its own for an abortion typically need to take more for it to work, and the side effects can be more intense, Dr. Melissa L. Wong, an obstetrician/gynecologist and a fellow with Physicians for Reproductive Health, previously told CNN.

Abortions are on the rise in the United States, despite bans that have taken effect in more than a dozen states since the US Supreme Court’s Dobbs decision that revoked the federal right to abortion in June 2022.

There were more than 1 million abortions in the US in 2023, the highest rate in more than a decade and a 10% jump from 2020, according to a report released Tuesday by the Guttmacher Institute, a research and policy organization focused on sexual and reproductive health that supports abortion rights. The latest trends also suggest that medication abortion is a more common option than ever.

Although abortions all but stopped in the 14 states with total bans, nearly every other state had an increase in the number of abortions provided from 2020 to 2023. States bordering those with bans had particularly large increases.

“It is very possible that, while access was dramatically curtailed for people living in ban states, access substantially improved for residents of states without bans,” the authors wrote.

Research has long found that medication abortion is highly safe and effective, even when the patient does not see a doctor in person and gets the medicine through a telehealth or text appointment, a February study found.

Common side effects include vomiting, diarrhea, nausea, weakness and dizziness. These usually happen in the first 24 hours after the person takes the second drug in the two-medication regimen. Rare side effects include a fast heartbeat, fainting and fatal infections. There is a 0.4% risk of major complications, studies show.

There were about 5.9 million medical terminations of pregnancy with mifepristone from its approval in the US in 2000 through the end of 2022, with 32 reports of death in these patients. The deaths cannot be directly attributed to mifepristone, the FDA says, because of information gaps about patient health status and clinical management.

An abortion using mifepristone is effective 99.6% of the time, studies show. If the abortion is not complete, the person may need to take the medicine again. In extremely rare cases, they may have to have a surgical abortion.

Mifepristone’s safety is on par with common over-the-counter pain relievers like ibuprofen and acetaminophen, studies show.

Data analyzed by CNN shows that mifepristone is even safer than some of the most common prescription medications. The risk of death from penicillin, an antibiotic used to treat bacterial infections like pneumonia, for example, is four times greater than it is for mifepristone. The risk of death after taking Viagra — used to treat erectile dysfunction — is nearly 10 times higher.

In 1937, a drugmaker called S.E. Massengill Co. came up with what seemed like an improvement on an effective medicine for sore throats: a liquid formulation that tasted like raspberry.

The only problem: The new formulation of the drug, called sulfanilamide, used diethylene glycol, which is essentially poison. More than 100 people, many of them children, died after taking it. The company didn’t know that diethylene glycol would be so dangerous, but it hadn’t been required to run toxicity studies before releasing a new product, and so it hadn’t done so, according to a US Food and Drug Administration account of the disaster.

The deaths led Congress the next year to pass the Federal Food, Drug and Cosmetic Act, which empowered the FDA to require drugs to be proven safe before they can be marketed. In 1962, Congress further expanded the FDA’s authority after the drug thalidomide was shown to cause severe birth defects — this time, to require that drugs be proven effective.

That dual mandate, in place for more than 60 years, has created a trusted drug approval process that could be upended by a case about the medication abortion drug mifepristone that’s being argued Tuesday in front of the US Supreme Court, according to doctors, former FDA commissioners, legal scholars, and pharmaceutical industry executives and investors.

“If the court ends up … ruling in any way in favor of the plaintiffs, it says that basically, anybody who may be ideologically opposed to medication approved by the FDA could try to go to court and overrule the scientific determination of the experts,” said Dr. Daniel Grossman, a professor at the University of California San Francisco and director of the university’s Advancing New Standards in Reproductive Health program.

Read more about the impacts of the ruling.

The Supreme Court will hear arguments soon to determine if restrictions on the use and access of a widely used abortion drug should be reinstated. A federal appeals court previously ruled to block changes made by the Food and Drug Administration to make mifepristone more widely available. The changes came in 2016 and 2021.

The conservative Alliance Defending Freedom, which is bringing the cases against the Biden administration and a drug manufacturer, argued in a brief to the court that the FDA did not “explain why it was proper” to eliminate some of these restrictions “without a study showing their cumulative safety.”

Danco Laboratories, a manufacturer of the drug and an intervenor in the case, argued in a filing to the court that the FDA does not have to cite a clinical study to make changes and that the agency “fully explained why it approved each specific change based on years of real-world experience.”

Here are some of the key changes at the center of the case:

In 2016:

In 2021:

An academic publisher retracted some studies used by a Texas judge in a ruling that aimed to suspend federal approval of mifepristone.

Sage Publications made the retractions in February. It said they were based on unreliable data and conflicts of interest around the authors’ ties to the anti-abortion movement. The studies were published in the Sage Journal Health Services Research and Managerial Epidemiology.

Sage said it asked outside experts to review the research that was a foundation for these studies after hearing from a reader who said the data was used to draw misleading conclusions. The experts concluded that the data used in the 2021 and 2022 studies had invalid conclusions based on the study design, “unjustified or incorrect” assumptions about its facts, errors in the authors’ analysis of the data and “misleading presentations of the data.”

In a statement, Jim Studnicki, the lead author of the studies and vice president at the Charlotte Lozier Institute, said that the authors “fully complied with Sage’s conflict disclosure requirements” and that funding and organizational affiliations were reported. Studnicki also disagreed with the publisher’s claims about the data.

A majority of Americans oppose a national ban on medication abortion and are uncertain about a widely used abortion drug’s future, according to results from a poll released earlier this month. It comes as the Supreme Court is set to weigh in on the issue, hearing oral arguments in a case that could restrict access to the drug, mifepristone.

Two-thirds (66%) of US adults say they oppose banning the use of mifepristone, or medication abortion, nationwide, and 62% oppose making it a crime for healthcare providers to mail abortion pills to patients in states where abortion is banned, according to the KFF poll.

Among women ages 18-49, 71% are opposed to a nationwide ban on medication abortion. Such a ban has limited support even among the GOP, with only 50% of Republicans saying they’d favor banning medication abortion nationwide.

At the same time, KFF found that most Americans have heard little about the upcoming Supreme Court case and much of the public remains uncertain about the pill’s current legality. A 64% majority of US adults say they’ve heard nothing at all about “an upcoming Supreme Court case about mifepristone, or the medication abortion pill,” and only 45% can correctly answer whether medication abortion is currently legal in their state.

Note: The KFF Health Tracking Poll was conducted February 20-28 and surveyed 1,316 US adults by telephone or using a nationally representative online panel. Results among the full sample have a margin of error of +/- 3 percentage points.

The fate of the abortion pill lies with the Supreme Court.

The high court, which has a conservative supermajority, holds the power to maintain full access to the drug or reverse regulation changes that made medication abortion more accessible in recent years. This includes allowing the pills to be prescribed via telemedicine, delivered in the mail and used up to 10 weeks of pregnancy instead of seven.

See a timeline of mifepristone access since it was approved in 2000:

The Justice Department and the manufacturer of a widely used abortion pill urged the Supreme Court in January to preserve full access to the drug, warning that a lower-court ruling restricting its availability “threatens profound harms” nationwide.

“The loss of access to mifepristone would be damaging for women and healthcare providers around the Nation. For many patients, mifepristone is the best method to lawfully terminate their early pregnancies,” Solicitor General Elizabeth Prelogar told the justices in court papers.

The filings from the Justice Department and Danco Laboratories, a manufacturer of the drug and an intervenor in the case, laid out their arguments for why the justices should overturn the lower-court ruling that curbed access to mifepristone. They also argued that the drug’s challengers didn’t have the legal right — known as “standing” — to sue the government over its approval of the drug and the regulatory regime that eased access to it.

Central to the dispute is the scope of the FDA’s authority to regulate mifepristone, a drug that the medical community has deemed safe and effective and is used by more than half of women to terminate their pregnancies, according to the government.

A federal appeals court previously blocked changes made by the FDA in 2016 and 2021 that made the drug more accessible. The Supreme Court could rule to reinstate those restrictions.

Mifepristone, which is also sold under the brand name Mifeprex or Korlym and sometimes known as RU 486, is one of two drugs most often used in the US in what is sometimes called a medication or medical abortion. The other is called misoprostol.

Mifepristone blocks a hormone called progesterone, which the body needs for a pregnancy to continue. The hormone helps maintain the inside of the uterus. When the hormone is absent, the uterus expels its contents.

After taking mifepristone, the patient waits 24 to 48 hours to take misoprostol. That helps empty the uterus through bleeding and muscle contractions. The drugs typically cause intense cramps and heavy bleeding for about three to five hours. A regular menstrual period will usually resume in a couple of weeks.

Within 14 days of taking the medicine, the patient takes a pregnancy test to determine whether the abortion is complete. If it isn’t, depending on the timing, they may need to take more medication, or in extremely rare cases they may need a surgical abortion. At a follow-up appointment, a medical professional may also check for infection.

The drugs can be taken immediately after someone learns that they’re pregnant, up to 10 weeks after the first day of the last menstrual period. The FDA approved mifepristone, coupled with misoprostol, for abortion in 2000.

The Supreme Court will consider whether to restrict access to a widely used abortion drug on Tuesday. Central to the dispute is the scope of the US Food and Drug Administration’s authority to regulate mifepristone, a drug that the medical community has deemed safe and effective.

The drug was initially approved by the FDA in 2000, but in 2016, 2019 and 2021, the FDA put in place modifications that would make the drug more easily accessible. Those modifications were related to things like dosing and in-person dispensing requirements. The changes also allowed the drug to be taken later in pregnancy.

Challengers argue that the FDA did not do enough to study the safety implications of the drug when it approved its use and made it more easily accessible in subsequent years.

How we got here: The legal volleying jumpstarted this spring, when US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, issued a ruling that would have halted the FDA’s 2000 approval of the drug.

At the 5th US Circuit Court of Appeals, the conservative court backtracked somewhat, saying that while it was too late for the challengers to mount a case against the initial 2000 approval of the drug and left in place the 2019 approval of a generic version of the drug, it would block changes made in 2016 and 2021.

The Supreme Court then agreed to consider an appeals court decision that restricted access to the drug, they declined a separate appeal by the abortion foes to consider if the FDA’s 2000 approval of the drug was unlawful.

Retired Justice Stephen Breyer has a new book out Tuesday explaining how his pragmatic approach compares to the current majority’s reliance on originalist and textualist methods, and Breyer uses Dobbs as a prime example of those methods’ shortcomings.

He re-emphasizes a point from his Dobbs dissent that the majority’s approach “consigns women to second-class citizenship,” and he newly warns that “The Dobbs majority’s hope that legislature and not courts will decide the abortion question will not be realized.”

In the June 2022 case of Dobbs v. Jackson Women’s Health Organization, a slim five-justice majority overturned the 1973 case of Roe v. Wade, which had held that the 14th Amendment guarantee of liberty protected a woman’s right to have an abortion.

“In Dobbs,” Breyer observes in his new book, “the majority’s reasoning boiled down to one basic proposition: Because the people who ratified the original Constitution and the Fourteenth Amendment did not understand the document to protect reproductive rights, the document could not be read, now, as protecting those rights.”

“The dissent, which Justices (Sonia) Sotomayor, (Elena) Kagan, and I authored together, pointed out that ‘people’ did not ratify the original Constitution in 1788 or the Fourteenth Amendment in 1868. White men did. Women were not understood as full members of the political community at either of these points in history. Indeed, they would not gain the right to vote until 1920.”

Breyer also argues in the book that the court’s Dobbs decision significantly compromised the court’s usual adherence to precedent, known in Latin as stare decisis, when it overturned Roe and the 1992 decision in Planned Parenthood of Southeastern Pennsylvania v. Casey.

“My point is simply this: One cannot claim that facts or values have changed since the Court decided Roe and Casey. At least, they have not changed in any way that might justify departing from stare decisis and overruling those earlier cases.

“Even if the majority’s account of abortion’s history were right – which it is not – that could not justify overruling those two earlier cases unless, of course, the Court is free to overrule every earlier case that a textualist or originalist approach might claim is wrongly decided. But that claim, as I have said, means an end to stare decisis. And that points to chaos.”

Ahead of oral arguments on Tuesday at the Supreme Court about the use of the medication abortion pill mifepristone, the Biden campaign is doubling down on its assertion that reproductive rights will be a galvanizing issue for voters this November.

The high court will ultimately decide whether to maintain full access to the drug or reverse regulation changes that made medication abortion more accessible in recent years.

Biden campaign manager Julie Chavez Rodriguez said the case “could strip away access to medication abortion everywhere in this country” and would mark “the biggest step towards Donald Trump’s ultimate goal of a nationwide abortion ban since Roe was overturned,” adding that its impact could be “disastrous.”  

In a call with reporters one day before the opening arguments, Rodriguez highlighted Trump’s appointment of three conservative justices to the court, adding that his “extreme MAGA Republican allies are ripping away access to reproductive health care across the country” and that a second term for the former president would “go even further” in curbing abortion access.

Rodriguez said that the campaign plans to continue to press “how extreme and out of touch” Trump’s positions are as it courts moderate voters on the issue.