Supreme Court protects access to widely used abortion drug

The Supreme Court handed a win to the defenders of the medication abortion drug mifepristone by pausing lower court rulings that would have disrupted access to the drug as a result – from a lawsuit filed by anti-abortion doctors seeking to wipe away the US Food and Drug Administration’s two-decade-old approval of mifepristone. 

That means FDA’s current regulatory scheme around the drug remains in place, ensuring that access to medication abortion — in the states where it is legal — is maintained at least for the next couple weeks, and likely longer. 

What comes next in the case? 

There is much still to play out in the litigation and Friday’s Supreme Court order is unlikely to be the justices’ final word on the FDA’s approach to regulating the drug. 

The case now travels back to the Fifth Circuit federal appeals court, which has set an expedited briefing schedule to give a fuller review of Kacsmaryk’s ruling. A three-judge panel from the Fifth Circuit will hold a hearing on May 17 and issue another decision sometime after. (There is no deadline for the Fifth Circuit to rule.)

The majority of judges on the Fifth Circuit are conservative, but it is unknown who the three judges will be. Notably, the three judges who will hear that step of the appeal will likely be different from those that issued the appellate order last week. 

The Supreme Court’s Friday order maintains the status quo around the drug’s regulations until that Fifth Circuit process plays out and until the justices have another chance to weigh in on how it handled the case. 

What do we know about how the justices are thinking about the dispute? 

The Supreme Court did not show its cards in the order it issued Friday night. 

While Justices Clarence Thomas and Samuel Alito made their dissents public, it is not otherwise clear how the justices voted or what the exact vote count was. The support of five justices is required for the court to grant a stay.

Only Alito wrote additionally to explain his dissent and stressed he was not expressing any views on the merits of whether the FDA broke the law in how it approached mifepristone. 

Instead, he aired grievances about how the Supreme Court’s conservative majority has been criticized for handling the emergency disputes — on its so-called shadow docket — in the past. He also cast doubt on the claims by the government and the manufacturer that the Fifth Circuit order would have caused mass disruption to access to the drug. 

Read more here

Alito poses for an official portrait on October 7, 2022, in Washington, DC.

Justice Samuel Alito, in his dissent Friday, said he voted to deny the request for a stay because the Fifth Circuit federal appeals court has scheduled such an expedited hearing on the merits of the dispute.

He suggested that allowing the restrictions to remain in place would not lead to “any real harm during the presumably short period at issue.”

Alito wrote that the stay would not “remove mifepristone from the market” but would have simply restored “the circumstances that existed” from the time the drug was approved in 2000 to when the FDA passed new regulations to ease access to the pill starting in 2016.

No other justice joined his dissent.

It’s almost guaranteed the case on medication abortion restrictions will land back before the justices of the Supreme Court after Friday’s order protected access at least until legal appeals play out.

The next step in the litigation will be a hearing in front of the New Orleans-based Fifth Circuit federal appeals court on May 17. Regardless of that outcome, it is very likely the losing side will appeal again to the Supreme Court.

“The case could well come back to the justices once the Fifth Circuit rules,” said Steve Vladeck, CNN Supreme Court analyst and professor at the University of Texas School of Law.

But nothing will change in regard to access to mifepristone unless the justices decide to consider the lawsuit’s merits and then side with the challengers, Vladeck continued.

“That’s not going to happen for a long time – if ever,” he said. 

Schumer at the Capitol in Washington, D.C. on Tuesday, April 18.

Reaction poured in Friday evening from Democratic officials and lawmakers after the Supreme Court issued an order protecting access to a widely used abortion drug until the legal appeals process plays out.

Here’s what some had to say:

Senate Majority Leader Chuck Schumer: The New York lawmaker issued a statement saying, “extreme MAGA Republicans will continue to pursue their nationwide abortion ban until they impose their anti-choice agenda on all Americans.”

“Democrats won’t stop fighting and we will prevail,” Schumer vowed.

California Gov. Gavin Newsom: “For now, the Court has followed science, data, and the law rather than an extreme and out of touch political agenda. Medication abortion is available and accessible here in California and we will continue to fight to protect people’s freedom to choose,” Newsom wrote in a statement.

HHS Secretary Xavier Becerra: “Today’s action from the Supreme Court is an important step in the right direction as we vigorously fight to defend the FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs,” the secretary for the US Health and Human Services Department said in a statement. “We are confident the law is on our side and remain focused on prevailing in court.” He added: “We will never stop fighting to preserve women’s rights to access the health care they need and Americans’ rights to access safe and effective medicine.”

North Carolina Gov. Roy Cooper: “We must not be complacent as we continue to fight the legal and political attacks on women’s health and freedom,” Cooper tweeted Friday.

New York Gov. Kathy Hochul: “We will continue the fight to protect reproductive rights and keep New York a safe harbor for all,” Hochul tweeted. “Under my watch, abortion — including medication abortion — will always be protected and available in New York.”

Michigan Gov. Gretchen Whitmer: “We need to be clear about why this case came before the court in the first place: a fringe, extreme minority that refuses to follow science or respect Americans’ freedoms is judge shopping to impose their agenda on women,” Whitmer tweeted.

Illinois Gov. JB Pritzker: “The Justices have recognized that this safe, tested drug should continue to be available to provide the gold standard of reproductive care and not be restricted based on a single ruling by an ideologically motivated judge,” Pritzker tweeted.

A lawyer for the group of doctors that brought the abortion drug lawsuit downplayed Friday’s Supreme Court order that protects access to the pill at least until appeals play out.

As the case moves forward in federal appeals court, Baptist said the FDA “must answer for the damage it has caused to the health of countless women and girls and the rule of law by failing to study how dangerous the chemical abortion drug regimen is and unlawfully removing every meaningful safeguard, even allowing for mail-order abortions.”

About the drug’s safety: Data analyzed by CNN shows mifepristone, the medication abortion drug at the heart of the Texas abortion lawsuit, is even safer than some common, low-risk prescription drugs, including penicillin and Viagra.

Medication abortion has become the most common method for abortion, accounting for more than half of all US abortions in 2020, according to the Guttmacher Institute.

Vice President Kamala Harris holds up a map displaying abortion access in the United States, while delivering remarks during the first meeting of the interagency Task Force on Reproductive Healthcare Access in the Indian Treaty Room of the Eisenhower Executive Office Building, next to the White House, in Washington, DC, on August 3, 2022.

Vice President Kamala Harris applauded a Supreme Court ruling Friday temporarily protecting access to mifepristone, a medication abortion pill.

Prior to the ruling, Harris said in an interview airing on Telemundo Friday that the wave measures in red states restricting access to abortions could “criminalize doctors and nurses.”

The American College of Obstetricians and Gynecologists praised the US Supreme Court’s order to freeze a lower-court ruling that would restrict access to a medical abortion drug but said the legal battle has created confusion for healthcare providers.

Even though the Texas federal judge’s ruling has been on hold for the past several weeks, meaning that mifepristone has been available, the back and forth has left “clinicians uncertain as to whether and where they could prescribe the medication for abortion and miscarriage management,” said Iffath Abbasi Hoskins, the president of the American College of Obstetricians and Gynecologists, and Maureen G. Phipps, the CEO of the American College of Obstetricians and Gynecologists.

Planned Parenthood of Utah is shown on June 28, 2022, in Salt Lake City.

In light of the US Supreme Court protecting the use of mifepristone, Planned Parenthood is warning that while the drug will stay on the market for now, its availability to millions of women should not “be at the mercy of the court system.”

Critics argue that if the original ruling by a federal judge in Texas is upheld – along with the Fifth Circuit’s limitations on the use of mifepristone – it would validate a decision of a single judge or panel with no medical expertise over standards of science and clinical analysis.

Mifepristone has been safely prescribed since the FDA approved it two decades ago. But anti-abortion doctors and medical associations argued in the case that the agency violated the law in how it approved the drug for abortions in 2000.

“Planned Parenthood will continue to fight so that everyone can make their own decisions about their bodies, lives, and futures,” Johnson said.

A patient prepares to take mifepristone, the first medication in a medical abortion, at Alamo Women's Clinic in Carbondale, Illinois, in April.

The immediate effects of the Supreme Court’s order on medication abortion access is a return to the status quo, said Elizabeth Cohen, CNN’s senior medical correspondent.

The order means that the US Food and Drug Administration’s approval of the drug mifepristone will remain in place while appeals play out, potentially for months to come. Mifepristone is the first of a two-drug combination used in the majority of abortions in the US, and also used off-label to treat miscarriages.

Cohen said Friday’s order clears things up for doctors who had been navigating their care decisions based on “haphazard, random decisions on a Friday night,” referring to previous rulings that put the drug’s access in doubt.

President Joe Biden arrives for an event in the Rose Garden of the White House April 21 in Washington, DC.

President Joe Biden responded Friday to a Supreme Court ruling protecting access to medication abortion as appeals play out in lower courts, saying the original ruling blocking FDA approval of mifepristone “would have undermined FDA’s medical judgment and put women’s health at risk.”

Biden urged Americans “to use their vote as their voice, and elect a Congress who will pass a law restoring the protections of Roe v Wade.”

Vice President Kamala Harris waves after speaking during a march for abortion rights from Pershing Square to City Hall in Los Angeles on April 15.

The Supreme Court’s decision to protect access to mifepristone, a drug used in medical abortions, while the appeals process plays out is a victory for the Biden administration and abortion rights activists.

The court’s Friday brief, unsigned order did not explain why it granted the request by the Biden administration and a manufacturer of the drug to intervene. Justices Clarence Thomas and Samuel Alito publicly dissented.

The case is the most important abortion-related dispute to reach the high court since the justices overturned Roe v. Wade, triggering conservative states nationwide to either ban or severely restrict the procedure. How the dispute over medication abortion is ultimately resolved could make it more difficult for women to obtain an abortion, even in the states that still allow it.

At issue is the scope of the FDA’s authority to regulate mifepristone, a drug that the medical community has deemed safe and effective. Millions of women across the country have used mifepristone in the more than two decades that it has been on the market.

The next step in the litigation will be a hearing in front of a New Orleans-based federal appeals court on May 17.

The issue of access to a widely used abortion drug will now proceed through the appeals process, CNN legal analyst Steve Vladeck said, following the US Supreme Court’s decision to freeze lower-court rulings that placed restrictions on mifepristone.

Vladeck said the order from the justices is not necessarily the court weighing in on how they are leaning on legal arguments, but more about allowing the case to go through the Fifth Circuit Court of Appeals.

Earlier this month, a federal judge in Texas ruled to change the FDA’s rules for use of the medication abortion drug. Vladeck said if this ruling was allowed to go into effect on Friday, without the Supreme Court stepping in, it would have created confusion for providers and women around the country.

Data analyzed by CNN shows mifepristone, the medication abortion drug at the heart of the Texas abortion lawsuit, is even safer than some common, low-risk prescription drugs, including penicillin and Viagra. There were five deaths associated with mifepristone use for every 1 million people in the US who have used the drug since its approval in 2000, according to the US Food and Drug Administration as of last summer. That’s a death rate of 0.0005%.

Comparatively, the risk of death by penicillin — a common antibiotic used to treat bacterial infections like pneumonia — is four times greater than it is for mifepristone, according to a study on life-threatening allergic reactions. Risk of death by taking Viagra — used to treat erectile dysfunction — is nearly 10 times greater, according to a study cited in the amicus brief filed by the FDA.

“[Mifepristone] has been used for over 20 years by over five million people with the capacity to become pregnant,” said Ushma Upadhyay, an associate professor in the department of obstetrics, gynecology and reproductive science at the University of California, San Francisco. “Its safety is very well established.”

Weighing medication abortion against the alternatives: Medication abortion has become the most common method for abortion, accounting for more than half of all US abortions in 2020, according to the Guttmacher Institute.

The growing popularity of medication abortion is largely because of its accessibility, said Abigail Aiken, associate professor at the University of Texas at Austin who leads a research group on medication abortion.

“It reduces the cost, it reduces barriers where people may not want to go to a clinic,” she said.

It is also a safer option than both procedural abortion or childbirth. The rate of major complications — like hemorrhages or infections — for medication abortions is about one-third of a percent, according to a 2015 study conducted by Upadhyay. That means out of more than 11,000 cases, 35 experienced any major complications.

The likelihood of serious complications via procedural abortion — performed second-trimester or later — is slightly higher than medication abortion at 0.41%, according to the same study. And childbirth by far comes with the highest risk, at 1.3%.

Krissy Shields, of New York City, talks with her daughters after creating the shape of a uterus out of flowers by the steps of the Supreme Court, Friday, April 21, in Washington, DC. "I wanted to make this uterus as a prayer for reproductive freedom for every body," says Shields, "I'm not worried about my kids I'm worried about all kids." 

The Supreme Court on Friday protected access to a widely used abortion drug by freezing lower-court rulings that placed restrictions on medication abortion.

As a result, the US Food and Drug Administration’s approval of the drug mifepristone — and subsequent actions that made it more easily accessible — will remain in place while appeals play out, potentially for months to come.

Justice Clarence Thomas and Justice Samuel Alito publicly dissented. 

A federal appeals court has already announced a briefing schedule with oral arguments to be heard mid-May.

A patient prepares to take Mifepristone, the first medication in a medical abortion, at Alamo Women's Clinic in Carbondale, Illinois.

Mifepristone is a drug approved by the US Food and Drug Administration that has been shown to be safe and effective for more than two decades.

The lawsuit from anti-abortion advocates claims that the drug is not safe and that the FDA didn’t study it enough to approve it.

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.

Here are some key things to know:

How mifepristone works: 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, which signed an amicus brief in the Texas case.

This medicine combination for abortion is also available in more than 60 other countries.

Since its approval in the US in 2000, there have been 5 deaths associated with mifepristone for every 1 million people who used it, according to the US Food and Drug Administration. That means the death rate is 0.0005%.

Mifepristone’s safety is on par with those of 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.

Side effects of mifepristone: Mifepristone usually doesn’t have many side effects, doctors say, but as with any drug, there can be short-lived ones.

Side effects of mifepristone may include dizziness, weakness, vomiting, headache, diarrhea, nausea, and fever or chills, according to the FDA.

Major adverse events like blood loss, hospitalization or a significant infection are “exceedingly rare,” happening in less than 0.3% of patients, according to the medical associations’ amicus brief.

How often is mifepristone used? The mifepristone-misoprostol combination is the most common abortion method in the US.

Preliminary data published February 2022 from the Guttmacher Institute, a research and policy organization focused on sexual and reproductive health that supports abortion rights, showed that medication abortion accounted for 53% of all abortions in the US.

Read more about the drug here.

The Supreme Court Building on April 19, 2023 in Washington, DC.

Supreme Court Justice Samuel Alito on Wednesday temporarily extended a hold on a lower court ruling that would have imposed restrictions on access to an abortion drug, a move meant to give the justices more time to consider the issue.

In a similar order last week, Alito had said the court would rule by 11:59 p.m. ET on Wednesday. The new order – called an “administrative stay” – moved that deadline to tonight, Friday, April 21.

The order was written by Alito because he has jurisdiction over the lower court that ruled in the dispute.

The case is the most important abortion-related dispute to reach the high court since the justices overturned Roe v. Wade last term, triggering conservative states across the country to either ban or severely restrict the procedure. How the dispute over medication abortion is ultimately resolved could make it more difficult for women to obtain an abortion, even in the states that still allow it.  

At issue is the scope of the US Food and Drug Administration’s authority to regulate a drug, mifepristone, that the medical community has deemed safe and effective.

Mifepristone has been used by millions of women across the country in the more than two decades that it has been on the market. 

Three members of the Women's March group protest in support of access to abortion medication outside the Federal Courthouse on Wednesday, March 15, in Amarillo, Texas.

Anti-abortion doctors and medical associations argue that the Food and Drug Administration (FDA) violated the law in how it went about approving mifepristone for abortions in 2000. They filed their lawsuit in November in Amarillo, Texas, where US District Judge Matthew Kacsmaryk – a Trump appointee who has previously issued major rulings against the Biden administration – was guaranteed to hear the case.

Kacsmaryk issued a sweeping ruling on April 7 that embraced the challengers’ arguments – which have been refuted by the mainstream medical community – that mifepristone was unsafe and halted the FDA’s 23-year-old approval of the pill.

The Biden administration, along with mifepristone manufacturer Danco Laboratories, took the dispute to the 5th Circuit, which issued an emergency order just before midnight last Wednesday. The 5th Circuit reinstated the drug’s approval, but said aspects of the lower court ruling that blocked the FDA’s more recent regulatory actions could go into effect.

Those actions include 2016 changes to mifepristone’s instructions that extended the window of use from seven to 10 weeks into the pregnancy, that reduced the number of in-person clinic visits required under the regimen from three to one, and that allowed non-doctors to administer the drug. The appeals court order also would reverse FDA’s later elimination of the requirement for in-person pick up of the drug– allowing it to be shipped to patients via the mail – as well as its 2019 approval of a generic version of mifepristone.

In filings with the Supreme Court, the Justice Department said that implementing those changes would “deny women lawful access to a drug FDA deemed a safe and effective alternative to invasive surgical abortion,” while putting the FDA and the entities it regulates “in an impossible position.”

The pill’s challengers, meanwhile, argue that the 5th Circuit’s ruling was a “reasonable order” and that the lower courts are justified in the actions they are taking against the FDA.

Matthew Kacsmaryk, judge of the United States District Court for the Northern District of Texas.

The federal district judge who first suspended the US Food and Drug Administration’s approval of the so-called abortion pill mifepristone failed to disclose during his Senate confirmation process two interviews on Christian talk radio where he discussed social issues such as contraception and gay rights.

In undisclosed radio interviews, Matthew Kacsmaryk referred to being gay as “a lifestyle” and expressed concerns that new norms for “people who experience same-sex attraction” would lead to clashes with religious institutions, calling it the latest in a change in sexual norms that began with “no-fault divorce” and “permissive policies on contraception.”

Kacsmaryk, a Trump-appointed federal district judge, made the unreported comments in two appearances in 2014 on Chosen Generation, a radio show that offers “a biblical constitutional worldview.” At the time, Kacsmaryk was deputy general counsel at First Liberty Institute, a nonprofit religious liberty advocacy group known before 2016 as the Liberty Institute, and was brought on to the radio show to discuss “the homosexual agenda” to silence churches and religious liberty, according to the show’s host.

Federal judicial nominees are required to submit detailed paperwork to the Senate Judiciary Committee ahead of their confirmation process, including copies of nearly everything they have ever written or said in public, in order for the committee to evaluate a nominee’s qualifications and personal opinions. Neither interview is listed in the paperwork Kacsmaryk provided to the Senate during his judicial nomination process, which first began in 2017.

The radio interviews were not included in the 22 media works Kacsmaryk disclosed, which included three radio appearances and 19 written pieces.

A spokesperson for Democratic Sen. Dick Durbin, the chair of the Senate Judiciary Committee, told CNN the interviews weren’t in their archived files from Kacsmaryk’s confirmation, which included all paperwork submitted for his nomination.

In a statement sent to CNN, Kacsmaryk said he did not locate the interview when searching for media to disclose and he did not recall the interview.

Read more here.

Sen. Dick Durbin questions U.S. Attorney General Merrick Garland as he testifies on "Oversight of the Department of Justice", before the Senate Judiciary Committee on Capitol Hill in Washington, DC, on March 1.

Key senators say discussions on a legislative solution to secure access to abortion pills are not happening yet. 

Sen. Dick Durbin, Democratic Whip and Judiciary chairman told CNN on Wednesday that there are “not yet” conversations on how or if they might try to handle the issue legislatively if the Supreme Court rules to limit access to the medication abortion drug mifepristone.

Republican Sen. Lisa Murkowski, a supporter of abortion rights, said that she isn’t currently working with Democrats on any legislation specific to the abortion medication. She did say she’s having talks about what “options might be out there.”