U.S. Supreme Court Rejects Texas Abortion Pill Challenge

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Mifepristone, a drug commonly used to induce abortion, will remain on the market without additional restrictions after the U.S. Supreme Court unanimously rejected an anti-abortion group's challenge to the drug's approval.

In the first high court ruling on abortion since the overturning of Roe v. Wade in 2022, the nine judges decided not to change anything in the legal status of the drug. The ruling is a rebuke to the 5th U.S. Circuit Court of Appeals and District Judge Matthew Kacsmaryk of Amarillo. The opinion was written by Justice Brett Kavanaugh, with a concurring opinion from Justice Clarence Thomas.

Medical abortion, usually performed with a combination of mifepristone and misoprostol, is the most common method of abortion in the United States. In the nearly 25 years since it was first approved by the U.S. Food and Drug Administration, mifepristone has been conclusively proven to be safe and effective.

That case originated in Amarillo, where a single anti-abortion judge hears almost all cases, and then went to the conservative 5th Circuit in New Orleans, which upheld most of the decision. The Supreme Court then intervened and allowed mifepristone to remain on the market while the case progressed.

What you need to know about mifepristone What is the current legal status of mifepristone in the United States?

Mifepristone is still generally approved for use up to 10 weeks of pregnancy. A federal judge in Amarillo initially revoked the Food and Drug Administration's approval of mifepristone after an anti-abortion medical group questioned FDA decisions making the drug easier to access, but the Supreme Court of the United States said the doctors did not have standing to sue and dismissed. their trial.

Are medical abortions legal in Texas?

Although mifepristone remains approved by the FDA, it is still illegal to perform an abortion in Texas, including distributing or mailing the abortion-inducing drugs mifepristone and misoprostol. Texas laws do not criminalize the person who has an abortion. Some Texans have found ways to obtain abortions by traveling to other states or Mexico, or by managing their own abortions at home by obtaining medications from international nonprofit organizations, such as Aid Access, or online stores.

Where are medical abortions legal?

Abortion is still legal in many states. The closest states to Texas are New Mexico, Colorado and Kansas. To learn more about abortion options and requirements outside of Texas, contact an abortion clinic or provider in states where it is still legal.

Are mifepristone and misoprostol safe?

Mifepristone, used along with misoprostol, is the most common way for Americans to terminate pregnancies. Numerous studies have shown that mifepristone is safe and effective and is recommended by the American College of Obstetricians and Gynecologists and the World Health Organization. It was approved by the FDA in 2000. Misoprostol, which is also used to treat stomach ulcers, may also be used to terminate a pregnancy alone when taken in higher doses or with other medications . It may be less effective than when taken with mifepristone, but studies in other countries have also demonstrated its safety.

With abortion virtually banned in more than a dozen states, these drugs have become a key part of the strategy to help people continue to access the procedure and, therefore, a major priority for groups anti-abortion.

The ruling comes as a relief to abortion providers and advocates, but also to pharmaceutical companies, which had expressed concerns about the precedent of allowing a judge to overturn approval of a long-standing drug .

The Mifepristone Challenge in Texas

Mifepristone was first approved in 2000 for use with misoprostol to terminate a pregnancy for up to seven weeks. The medication is also commonly used to evacuate fetal tissue after a miscarriage.

Almost immediately, anti-abortion groups began challenging the drug's approval, beginning with a citizen petition in 2002. The FDA did not respond to the petition until 2016, rejecting it the same day it announced new guidelines allowing use of the drug for 10 weeks. of pregnancy.

In 2019, the FDA approved a generic version of mifepristone and later began allowing the drug to be prescribed via telehealth, distributed to retail pharmacies and sent by mail.

In November 2022, the Alliance for Hippocratic Medicine, an anti-abortion medical group, filed a lawsuit, arguing that the drug's initial approval in 2000 was inappropriate and should be rescinded, along with all the recent changes. The group filed the lawsuit in Amarillo, where all cases are being heard by U.S. District Judge Matthew Kacsmaryk, a former religious liberty attorney who has argued against abortion and access to contraception before to be nominated to the bench by President Donald Trump.

In a decision laced with anti-abortion rhetoric, Kacsmaryk ruled that the FDA's approval of mifepristone was inappropriate and should be revoked.

The Court does not question the FDA's decision lightly, Kacsmaryk wrote. But here, the FDA acquiesced to its legitimate safety concerns, in violation of its legal obligation, based on patently flawed reasoning and studies that did not support its conclusions.

Kacsmaryk gave the U.S. Department of Justice five days to appeal the decision before it took effect, which it did. The 5th Circuit ruled that the drug could remain on the market, but reinstated restrictions that were in place before 2016. The Supreme Court then stepped in and ruled that nothing regarding the approval of mifepristone would change until that the matter be resolved.

In late March, the Supreme Court heard arguments over whether the drug's status should remain unchanged or return to pre-2016 restrictions, when it could only be used for up to seven weeks of pregnancy, and not prescribed via telehealth or sent. by mail. The hearing also focused on whether the anti-abortion doctors who filed the lawsuit had the legal standing to pursue their lawsuit.

Reversing the FDA's changes would needlessly restrict access to mifepristone without a safety justification, U.S. Attorney General Elizabeth Prelogar argued. Some women may be forced to undergo more invasive surgical abortions. Others might not have access to the medicine at all. And all of this would happen at the behest of plaintiffs who have no certain prejudice. The Court should reject this deeply unfair result.

decision

In his opinion released Thursday, Kavanaugh wrote that plaintiffs cannot sue simply because they want to make a drug less accessible to others.

The decision notes that the plaintiffs bringing the lawsuit do not actually use or prescribe mifepristone and are not required by the FDA to do so and are therefore not affected by its availability in the market.

Federal law fully protects doctors from being forced to perform abortions or other medical treatments against their conscience and therefore breaks any chain of causation between the FDA's relaxed regulations on mifepristone and any violation of doctors' consciences, indicates the decision.

On a broader scale, doctors do not and should not have the power to change federal public health policy, and allowing the lawsuit to proceed would set a dangerous precedent, the ruling says.

Allowing doctors or other health care providers to challenge general safety regulations by accusing them of being illegally lax would be an unprecedented and limitless approach and would allow doctors to sue in federal court to challenge almost any policy affecting public health, we can read.

The decision also leaves open the possibility that another plaintiff, including one who could demonstrate direct harm or a sufficient likelihood of future harm, could successfully bring a lawsuit in the future.

But in this case, even assuming, for the sake of argument, that the FDA's 2016 and 2021 changes to the conditions under which mifepristone is used cause more pregnant women to require emergency abortions and that some women would likely seek treatment from these plaintiff doctors, the plaintiff doctors have not demonstrated that they could be forced to participate in an abortion or provide abortion-related medical treatment despite their conscientious objections, states the jugement.

In attendance: former U.S. Rep. Liz Cheney, R-Wyoming; U.S. Senator Jon Fetterman, Democrat of Pennsylvania; and Oklahoma Gov. Kevin Stitt will take the stage at the Texas Tribune Festival Sept. 57 in downtown Austin. Buy your tickets today!

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