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:

• Chief Justice John Roberts and Justice Neil Gorsuch tore into the challengers’ attorney over the impact caused by the lawsuit, suggesting a nationwide injunction was unnecessary.
• 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 plaintiffs could not demonstrate any injury to them stemming from the agency’s regulations.
• Justice Samuel Alito, who wrote the opinion reversing Roe v. Wade, and fellow ardent abortion opponent Justice Clarence Thomas, pushed the question of whether anyone can actually challenge the FDA on drug approvals. The FDA wants to be “infallible,” Alito said at one point.
• Alito said that a long-unenforced law, the Comstock Act, banning the mailing of drugs used for abortions was not “obscure” but rather a “prominent” law. Some anti-abortion activists see the law as an avenue to end medication abortion, and perhaps all kinds of abortions.
• That the challenge to mifepristone reached the Supreme Court in such a short amount of time was no accident – a result of the “judge-shopping” phenomenon seen recently on major political issues including health care, firearms and abortion.

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.