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Why Mifepristone Is on Trial at the Supreme Court

Vaidehi Mehta, Esq.

By Vaidehi Mehta, Esq.

Attorney Writer

Last updated on

Two years later, we’re not done talking about the overturning of Roe v. Wade. That’s because Roe wasn’t the last line of defense for reproductive rights in America. In fact, it may be the first of many more yet to fall.

Whether you’re pro-life or pro-choice or somewhere in between, you probably recall the end of the U.S. Supreme Court’s 2022 spring term, when the country waited with bated breath on the decision in Dobbs v. Jackson Women's Health Organization. Many weren’t expecting what came: walking back the right to abortion that was established in Roe.

Despite the Dobbs ruling, abortions are very much still happening throughout the country. Last year alone, there were more than a million recorded abortions performed in the U.S. Now, the same court that undid the right to abortion is about to hear oral arguments for restricting access to the most popular form of abortion in the country: mifepristone.

Mifepristone: A Medical Milestone

Pro-life groups have found their next legal target in “the abortion pill,” mifepristone, also known as RU-486. This medication is typically used in combination with misoprostol to terminate a pregnancy during the early stages — up to 10 weeks. It is over 99% effective in ending an early pregnancy.

Mifepristone is a progesterone receptor antagonist, which means it blocks the hormone progesterone, a hormone necessary to sustain a pregnancy. Misoprostol causes the uterus to contract and expel the pregnancy tissue. This combination of medications can be an alternative to surgical procedures like dilation and curettage (D&C) for managing miscarriages. Mifepristone can also be used to manage an incomplete miscarriage (to help complete a miscarriage that has started but not finished naturally).

Mifepristone was approved by the U.S. Food and Drug Administration (FDA) in 2000 for the medical termination of pregnancies up to seven weeks gestation. In 2016, the FDA extended this to ten weeks gestation. In April 2019, the FDA approved a generic version of mifepristone.

Initially, the FDA had required clinicians to distribute mifepristone in person, usually by keeping it in stock in their office. The FDA also required patients to make three visits to a health-care provider as they started taking the drug. By the third visit, which would be two weeks after the first, the doctor could confirm that the pregnancy had been terminated. In 2021, the FDA removed the in-person dispensing requirement for mifepristone. As a result, it could be dispensed by pharmacies. The FDA also expanded distribution to include certified clinicians. 

The drug is now used in nearly two-thirds of abortions in the country. Its use is also rising rapidly. Medication abortions made up 63% of all abortions in 2023, compared to 53% in 2020. 

The Alliance for Hippocratic Medicine 

A few months after SCOTUS issued Dobbs, a number of anti-abortion organizations and like-minded doctors came together to form the Alliance for Hippocratic Medicine (AHM). The group’s stated mission is to “uphold and promote the fundamental principles of Hippocratic medicine,” which it claims include “protecting the vulnerable at the beginning and end of life, seeking the ultimate good for the patient with compassion and moral integrity, and providing healthcare with the highest standards of excellence based on medical science.”

AHM has made many official statements on their stance that abortion has no place in the practice of medicine: “From the time the original Hippocratic Oath was introduced, there has been a clear separation of medical care from the intentional killing of human beings. The science is clear – at the moment of fertilization, a new distinct, living and whole human being comes into existence. Abortion, which is an action whose sole intent is to end this life, clearly violates the basic tenets of medical ethics.”

Critics of AHM argue that the group is using the Hippocratic Oath for political purposes. They point out that mifepristone is a safe and effective medication, and restricting access to it would harm women's health. But whatever the group calls itself, what’s clear is that it stands against abortion generally, including abortion using pills such as mifepristone.

AHM vs. FDA: Dispute Over Drug Approval

AHM took the FDA to court over its approval of mifepristone. The first legal complaint they filed claimed that the FDA failed to protect the health, safety, and welfare of women and girls when it approved mifepristone for use in the U.S.

Specifically, they asserted that the FDA’s authority to grant “accelerated approval” (which they used for mifepristone) is intended for drugs that treat serious or life-threatening illnesses and provide meaningful therapeutic benefits over existing treatments. Pregnancy, they argued, is not an illness, and chemical abortion drugs do not offer such benefits over surgical abortion.

They also claimed that the FDA violated federal laws by not requiring adequate testing and substantial evidence to demonstrate the drugs' safety and effectiveness, especially for the pediatric population. Additionally, they argue that the FDA's actions are in violation of the Comstock Act, which prohibits the use of mail to send drugs intended for producing abortion.

Later into the litigation, AHM modified its complaint with the FDA to be more about the 2016 and 2021 changes rather than the initial 2000 approval. The plaintiffs say in their complaint that even though the FDA “approved the high-risk abortion drug mifepristone and imposed critical safety requirements on its use,” they later “stripped away most of those standards without any study evaluating the changes under the new conditions of use and without a reasonable explanation.” The plaintiffs alleged that when the FDA waived the in-person visit requirement, “[i]t did so based on adverse event data that it elsewhere recognizes as unreliable and studies that it considered inadequate.”

The Case Goes to SCOTUS

The U.S. Supreme Court heard oral arguments in the case last Tuesday. Many legal experts thought the Court appeared unlikely to restrict access to the abortion pill based on their questioning. This was due to the Justices’ skepticism towards the legal standing of anti-abortion groups' challenge. You can read more about this issue in our blog that explores the nuances of the legal arguments before SCOTUS.

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