The US Supreme Court hears arguments Tuesday in a case concerning the authorization and regulation of the abortion pill mifepristone at a time when reproductive rights are at the heart of political division and changing policies across the nation. At the center of the case is the Alliance for Hippocratic Medicine’s lawsuit against the Food and Drug Administration (FDA), contending that the agency’s authorization of mifepristone for abortions failed to adequately protect women’s health. This case has garnered much attention since the fall of the constitutional right to an abortion in 2022 with the Dobbs v. Jackson Women’s Health decision.
Currently, mifepristone and other forms of medication abortion are increasingly inaccessible in more than 20 states. The Supreme Court decided to maintain access to mifepristone amid the ongoing legal battle in April 2023 despite a ruling from the US Court of Appeals for the Fifth Circuit that temporarily restricted access to the drug.
In this explainer, we aim to provide a comprehensive overview of the background, key arguments, and stakeholders involved in the legal dispute. We will delve into the nuanced perspectives surrounding the issue, shedding light on the FDA’s stance, arguments from various parties, and the broader implications for reproductive rights and healthcare regulation in the United States.
What is Mifepristone?
Mifepristone is a pill that can terminate a pregnancy up to 10 weeks gestation. It is typically taken with another medicine, misoprostol, which works to empty the uterus. According to the FDA’s website, mifepristone is safe and was approved by the agency more than 20 years ago based on extensive research. However, one amicus brief filed by Women and Families Harmed by Mifepristone and Former Abortion Providers alleges that research shows the use of mifepristone may cause “more pain, more nausea or vomiting, higher failure rate, more total blood loss, and greater risk of massive, life-threatening hemorrhage.” The group also asserts that the experience of taking mifepristone can be traumatic, leading to negative mental health consequences. Still, one study from 2015 of more than 13,000 women found that mifepristone use was safe, with rare rates of hospitalization.
Why is the FDA being sued over Mifepristone?
The Alliance for Hippocratic Medicine (AHM) filed a lawsuit in November 2022 against the Food and Drug Administration (FDA), claiming the agency failed to protect the health of women by authorizing mifepristone for abortions in 2000. AHM is a religious advocacy group that adheres to the Hippocratic medicine ideology, working to “protect the vulnerable at the beginning and end of life, seek the ultimate good for the patient with compassion and moral integrity, and provide healthcare with the highest standards of excellence based on medical science.” Also, the group believes life begins at conception as opposed to birth.
In its initial lawsuit, the AHM argued the FDA lacked the authority to approve the drug and removed safeguards to protect patients who take mifepristone. The AHM stated the FDA increased the length of time people could take mifepristone from 7 weeks to 10 weeks gestation, changed the requirements for physician monitoring while on the drug and increased the amount of misoprostol recommended when taking mifepristone. The lawsuit further alleged that multiple patients who took mifepristone suffered “intense side effects, including cramping, heavy bleeding, and severe pain” and suffered “significantly more complications than [people] who have surgical abortions.”
The AHM asserts the FDA made changes in 2016 and 2021 which increased the risk of harm to both women and doctors due to potential complications from taking mifepristone. In 2016, the FDA updated the guidelines for taking mifepristone, allowing it to be taken up to 10 weeks into a pregnancy, decreasing the number of times a patient taking the pill needs to visit a doctor and expanding the ability of non-physician healthcare professionals to give a prescription for the drug. The agency also decided to no longer require patients on mifepristone to report adverse side effects, like hospitalizations, because mifepristone’s safety profile had not changed for over 15 years. Finally, in 2021, the FDA no longer required that mifepristone be given in person. Now, mifepristone is accessible at pharmacies via a pharmacist and can even be mailed, which was finalized in 2023. (CVS and Walgreens will soon offer mifepristone at its pharmacies.)
Where does the FDA stand on the issue?
The FDA filed a brief with the Supreme Court laying out their arguments in January, which focuses on three main arguments. First, the FDA posits that the AHM does not meet the constitutional requirement for standing. Article 3 of the US Constitution contains requirements that a party must meet to bring a case. The party must show a concrete injury, that a court decision will remedy that injury and that there is a connection between the injury and the conduct of the other party. The FDA argues that AHM does not have an injury, nor did any harm stem from the FDA’s actions. The FDA’s brief explains that AHM is an “association of doctors who oppose abortion on religious and moral grounds. They do not prescribe mifepristone, and FDA’s approval of the drug does not require them to do or refrain from doing anything.”
Additionally, the FDA posits that their decisions were reasonable because they looked at an extensive 20-year review of medical studies and other relevant data.
What have others said about the case?
Other parties who have an interest in the outcome of the case filed amicus briefs, which are briefs to the Supreme Court in favor of a particular party. Over 600 state legislators filed a brief in support of the FDA, arguing that the Fifth Circuit’s decision curtails the ability of state legislators to regulate abortion in each state. The legislators recalled the principles emphasized in Dobbs, namely that “the decision undermines state legislatures’ ability to expand abortion access consistent with the FDA’s scientific judgment and approval processes.”
However, 145 members of Congress, including Florida Senator Marco Rubio, Colorado Representative Lauren Boebert and Georgia Representative Marjorie Taylor Greene, filed a brief in support of the AHM. They contend that the FDA did not follow proper procedures which has created “significant health and safety risks to women and girls.” The Congresspeople also claim that the FDA violated federal law when it changed its guidelines to allow mifepristone to be sent via the mail. Specifically, 18 US Code 1461 prohibits any item, substance or drug that induces abortion from being sent via the postal system.
