Appeals court embraces abortion-pill limits, sets up Supreme Court review (2023)


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A federal appeals court said Wednesday that it would restrict access to a widely used abortion medication after finding that the federal government did not follow the proper process when it loosened regulations in 2016 to make the pill more easily available.

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Food and Drug Administration decisions to allow the drug mifepristone to be taken later in pregnancy, be mailed directly to patients and be prescribed by a medical professional other than a doctor were not lawful, a three-judge panel of the conservative U.S. Court of Appeals for the 5th Circuit ruled.

Mifepristone will remain available for now under existing regulations while the litigation continues, in accordance with a Supreme Court order this spring. The Justice Department said it will go back to the Supreme Court to appeal Wednesday’s decision, which only partially upheld a lower-court judge’s ruling in favor of a coalition of antiabortion challengers.


If the Supreme Court allows the appeals court’s ruling to stand, the abortion pill would still be available in the United States, but it would be more difficult for patients to get it.

“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” Judge Jennifer Walker Elrod wrote in Wednesday’s opinion. “It failed to consider the cumulative effect of removing several important safeguards at the same time.”

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How mifepristone is used

What is mifepristone?

(Video) Biden Administration to seek Supreme Court review of an Appeals Court ruling on an abortion pill

Mifepristone is one of two drugs that work together to terminate a pregnancy, and is approved by the U.S. Food and Drug Administration through 10 weeks gestation. Mifepristone was first approved for use in France in 1988, and approved in the U.S. in 2000.

How a medication abortion works

A patient first takes mifepristone as a single pill, which blocks the hormone progesterone, preventing a pregnancy from progressing. About 24 hours later, the patient typically takes a four-pill dose of misoprostol to prompt contractions that expel the embryo or fetus.


A large body of research shows mifepristone is safe and effective. The American College of Obstetricians and Gynecologists analyzed hundreds of published studies, and found "serious side effects occur in less than 1% of patients, and major adverse events — significant infection, blood loss, or hospitalization — occur in less than 0.3%.”

Mifepristone and abortion access

Mifepristone is used in more than half of U.S. abortions, according to the Guttmacher Institute, a group that supports abortion rights. If mifepristone is taken off the market, abortion providers will have to provide only surgical abortions, or use a medication abortion regimen that includes only misoprostol.

Misoprostol-only medication abortion

A misoprostol-only abortion requires three doses of four pills each. While misoprostol is widely used on its own to perform abortions around the world, studies show it is less effective than the two-step regimen, and usually causes more cramping and potential side effects, including diarrhea, fever and chills.


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Erin Hawley, an attorney for the group that challenged mifepristone’s approval, said she was pleased with the court’s ruling even though she had argued that the drug should have never been approved in the first place.

Hawley said her team has not yet decided whether to appeal the part of the ruling that went against them. The Justice Department’s appeal, however, guarantees the high court will consider the issue.


(Video) Supreme Court rules on abortion pill access

“As the Attorney General has said before, the Justice Department is committed to defending the FDA’s scientific judgment and protecting Americans’ access to safe and effective reproductive care,” the Justice Department said in a statement. “The Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA and will be seeking Supreme Court review of that decision.”

Mifepristone, which was first approved for use in this country more than 20 years ago is part of a two-drug regimen used in more than half of U.S. abortions. The legal battle over the medication has intensified since the Supreme Court overturned Roe v. Wade’s grant of a constitutional right to abortion in June 2022, a decision that spurred multiple states to further limit or ban the procedure.

The challenge to mifepristone was brought by the Alliance for Hippocratic Medicine, an association of antiabortion doctors and others. The group asserted that the FDA did not sufficiently consider safety concerns when it approved the drug in 2000 or when it removed some restrictions years later — allowing the use of mifepristone through 10 weeks of pregnancy, for instance, instead of seven.


The challengers had argued that the abortion pill should never have been approved and should be removed entirely from the market. They filed their lawsuit in Amarillo, Tex., where U.S. District Judge Matthew Kacsmaryk — a Trump nominee with long-held antiabortion views — is the sole sitting judge.

Kacsmaryk sided with the challengers and issued an unprecedented ruling in April, for the first time suspending FDA approval of a human drug over objections from the agency. His ruling embraced language used by antiabortion activists, referring to abortion providers as “abortionists” and to fetuses and embryos as “unborn humans.”

It was quickly put on hold so the federal government and the drug manufacturer could appeal.

Two of the three judges on the appeals court — Elrod and Cory T. Wilson — did not go as far as Kacsmaryk in their opinion Wednesday. They ruled that too much time has lapsed for the challengers to mount a court challenge to the FDA’s 2000 approval of mifepristone. Because that statute of limitations has passed, the judges did not address whether the FDA followed proper protocol when it originally approved the drug.


They did rule, however, that the agency years later did not properly vet whether the medication would still be safe if it is not administered in-person.

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Where is abortion legal and illegal?

Appeals court embraces abortion-pill limits, sets up Supreme Court review (1)Appeals court embraces abortion-pill limits, sets up Supreme Court review (2)

We’re tracking states where abortion is legal, banned or under threat.

(Video) The Supreme Court allows access to mifepristone, the abortion pill, to continue for now | USA TODAY

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The Justice Department — which is representing the FDA — and the drug manufacturer Danco Laboratories, have emphasized the FDA’s reliance on dozens of studies involving thousands of patients to approve the medication, which has been used by more than 5 million women. Serious side effects occur in fewer than 1 percent of patients.

Lawyers defending the drug said the antiabortion challengers had no legal right — or standing — to file the lawsuit because they were not directly harmed by the FDA’s approval of the abortion pill. They also argued that allowing a court to revoke approval of an approved medication would jeopardize access to non-abortion drugs and more broadly harm medical research and innovation.


At oral argument in May, all three appeals court judges, who have previously supported abortion restrictions, seemed prepared to limit access to the medication.

An abortion ban made them teen parents. Now two years have passed.

Hawley, a lawyer for Alliance Defending Freedom — the law group representing the challengers — called the panel’s decision a victory for women’s health.

“The 5th Circuit rightly required the FDA to do its job and restore crucial safeguards for women and girls, including ending illegal mail-order abortions,” Hawley said in a statement.

The challengers also said in their lawsuit that the government should never have approved a generic version of mifepristone in 2019. But the appeals court said they did not have proper standing to challenge that decision, since they did not show that any of the doctors who joined the lawsuit were harmed by the generic version of the pill.


Wednesday’s ruling said the generic version of the medication should be subject to the same 2016 conditions as mifepristone.

The decision essentially echoed an earlier, initial review of Kacsmaryk’s opinion, in which a separate three-judge panel of the 5th Circuit declined to suspend approval of mifepristone but reversed actions taken by the FDA since 2016 to loosen restrictions.

(Video) What does the Supreme Court ruling on the abortion pill mean?

The Supreme Court put that appeals court decision on hold while the litigation continues.

Judge James C. Ho dissented from part of Wednesday’s opinion, saying the statute of limitations for challenging the initial approval of mifepristone has not lapsed and the challengers have standing to contest it. Ho, an outspoken conservative and former clerk to Supreme Court Justice Clarence Thomas, wrote that he would have invalidated the FDA’s initial approval and believes the agency’s decisions are subject to review by the courts, just like decisions made by any other agency.


“The scientists at the FDA deserve our respect and our gratitude, but not our blind deference,” Ho wrote.

A rollback to 2016 regulations would dramatically change how women access the abortion pill in this country, said Greer Donley, an associate professor at the University of Pittsburgh School of Law, noting in particular the potential restriction of the medication to the first seven weeks of pregnancy.

“This is an example where the Fifth Circuit seems to be really second-guessing the FDA’s decision,” she said.

Abortion access in America

Tracking abortion access in the U.S.: After the Supreme Court struck down Roe v. Wade, the legality of abortion is left to individual states. The Post is tracking states where abortion is legal, banned or under threat.

Abortion pills: The Justice Department appealed a Texas judge’s decision that would block approval of the abortion pill mifepristone. The Supreme Court decided to retain full access to mifepristone as the appeal proceeds. Here’s an explanation of what happens next in the abortion pill case.

Post-Roe America: With Roe overturned, women who had secret abortions before Roe v. Wade felt compelled to speak out. Other women who were seeking abortions while living in states with strict abortion bans also shared their experiences with The Post through calls, text messages and other documentation. Here are photos and stories from across America since the reversal of Roe v. Wade.

The U.S. fight over abortion


  • States where abortion is legal, banned or under threatAugust 9, 2023States where abortion is legal, banned or under threatAugust 9, 2023
  • Where 2024 presidential candidates stand on abortion bansMay 19, 2023Where 2024 presidential candidates stand on abortion bansMay 19, 2023
  • Democrats may embrace abortion rights even more tightly after Ohio winAugust 9, 2023Democrats may embrace abortion rights even more tightly after Ohio winAugust 9, 2023

(Video) Supreme Court pushes back its own deadline to rule on abortion pill access


Appeals court embraces abortion-pill limits, sets up Supreme Court review? ›

A federal appeals court said Wednesday that it would restrict access to a widely used abortion medication after finding that the federal government did not follow the proper process when it loosened regulations in 2016 to make the pill more easily available.

What is the undue burden in Roe v Wade? ›

Since its seminal ruling in Roe v. Wade (1973), the Supreme Court has recognized that the Constitution protects the fundamental right to choose abortion. The undue burden test is the legal standard that courts use to determine whether an abortion restriction violates the Constitution.

What company makes mifepristone? ›

Danco Laboratories is a pharmaceutical distributor located in midtown Manhattan which distributes the abortifacent drug mifepristone under the brand name Mifeprex.

What Supreme Court case covers reproductive rights? ›

In Planned Parenthood v. Casey, the Supreme Court developed the “undue burden” standard for reviewing abortion restrictions. It provided that a state could not place substantial obstacles in the path of a woman seeking an abortion before a fetus reaches viability.

What is an example of an undue burden? ›

If an auxiliary aid or service is an undue burden, the organization must look for an effective alternative. For example, if a small, private museum cannot afford to provide a sign language interpreter for a museum tour on short notice, a written copy of the tour guide's script might be an alternative.

What is considered an undue burden? ›

Undue burden means significant difficulty or expense.

Can pharmacies dispense mifepristone? ›

Mifepristone may only be dispensed by or under the supervision of a certified prescriber, or by a certified pharmacy on a prescription issued by a certified prescriber. To become certified to dispense mifepristone, pharmacies must complete a Pharmacy Agreement Form.

What is the most common brand name of misoprostol? ›

Misoprostol is a medication that can prevent stomach ulcers if you also take NSAID medications. It reduces the amount of acid in your stomach, which protects your stomach lining. The brand name of this medication is Cytotec®.

What are the side effects of mifepristone alone? ›

The most common side effects of Mifeprex treatment include: nausea, weakness, fever/chills, vomiting, headache, diarrhea and dizziness. Your provider will tell you how to manage any pain or other side effects. These are not all the possible side effects of Mifeprex.

Are reproductive rights protected by the Constitution? ›

The California Constitution guarantees everyone the right to privacy but does not define what this right includes. However, the California Supreme Court has found that this right to privacy includes the right to make reproductive choices, such as whether or not to have an abortion or use contraceptives.

Which Supreme Court justice ruled against abortion? ›

The Supreme Court on Friday eliminated the constitutional right to obtain an abortion, casting aside 49 years of precedent that began with Roe v. Wade. The decision by Justice Samuel Alito will set off a seismic shift in reproductive rights across the United States.

What are the three reproductive rights? ›

Reproductive rights consist of three broad categories of rights: (1) rights to reproductive self-determination, (2) rights to sexual and reproductive health services, information, and education, and (3) rights to equality and nondiscrimination.

What company makes misoprostol? ›

CYTOTEC®(misoprostol) | Pfizer Medical Information - US.

Who makes mifepristone in China? ›

The Hua Lian Pharmaceutical Co., based in the eastern city ofShanghai, has been contracted to make the raw compound in RU-486,mifepristone, for export to the United States, company executivesand Shanghai family planning officials said.

What is the generic name for mifepristone tablets? ›

Mifepristone is a generic drug, which is an exact copy of the active drug in a brand-name medication. The generic is considered to be as safe and effective as the original drug. And generics tend to cost less than brand-name drugs. Mifepristone is available as two different brand-name drugs: Korlym and Mifeprex.

What company manufactures the pill? ›

Wade, rescinding the right to abortion nationally. Perrigo Company, which manufactures the pill, says it will likely be available in stores and from online retailers in the United States in early 2024.


1. Supreme Court temporarily maintains 'status quo' on abortion pills
(NBC News)
2. Supreme Court weighs fate of abortion pill
3. CNN Supreme Court analyst on the Court's decision to extend access to abortion drug
4. DOJ asks appeals court to pause abortion pill ruling
(CBS News)
5. After Roe v. Wade, What Next?
6. A Discussion on Dobbs
(The Federalist Society)
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