The Supreme Court on Tuesday will hear oral arguments in the controversial case on the Food and Drug Administration’s approval of the abortion pill mifepristone, but relatively few are familiar with how the drug works.
Nearly 63% of all abortions in the United States in 2023 utilized mifepristone, according to the pro-abortion-rights Guttmacher Institute. However, a recent study from the healthcare policy think tank KFF found that nearly two-thirds of people had not heard of the impending Supreme Court decision on whether the FDA provided sufficient evidence of mifepristone safety before permitting the drug to be sold by mail.
Four in 10 adults are unsure whether mifepristone is legal in their state, irrespective of their state laws on abortion, which includes 38% of reproductive age women 18-49. About 13% of adults incorrectly believe that medication abortion is legal in their state.
With 1 in 8 likely voters in the 2024 election saying abortion access is their top motivating factor in choosing a presidential candidate, the Supreme Court decision, anticipated by June, will have potentially significant bearing on November’s election results.
Here is everything to know about mifepristone, both as a drug and in the context of the legal controversy.
Mifepristone is the first in a two-agent chemical abortion series that works by cutting off the supply of the hormone progesterone to the developing child in the womb. Within 24 to 48 hours of taking mifepristone, the patient is instructed to take the second agent, misoprostol, to start uterine contractions to expel the pregnancy.
Although it is possible to conduct a chemical abortion solely using misoprostol, the use of mifepristone in the self-managed abortion process in theory makes expelling the pregnancy — or, to use medical terms, “retained products of conception” — more likely to be complete.
Mifepristone and misoprostol are often used in miscarriage care under the guidance of OB/GYNs.
The FDA’s warning label on mifepristone estimates that between 2.9% and 4.6% of self-managed abortion patients will seek emergency medical treatment due to complications, including severe and sustained bleeding or potentially fatal infections. With nearly 643,000 medication abortions in 2023, that’s approximately 20,000 emergency visits for self-managed abortion patients.
Mifepristone was entirely banned in the United States from 1989 until 1993, when then-President Bill Clinton ordered the Department of Health and Human Services to begin investigations into the drug’s safety and efficacy for medication abortions in early pregnancy.
The drug received full FDA approval in September 2000 for use up to seven weeks of pregnancy. Patients were initially required to see a physician to confirm the gestational age of the pregnancy and rule out dangerous conditions that would make the drug ineffective, including ectopic pregnancy.
In 2016, the FDA increased the gestational age limit to 10 weeks of pregnancy and removed requirements for physicians to report adverse complications other than death. Data collected since 2016 has been used by the FDA to justify its decision in 2021 to remove the requirements for patients to see a physician in person prior to being prescribed mifepristone.
An amicus brief written in October 2023 by the group Food and Drug Law Scholars, affiliated with the Food and Drug Law Institute, argues that removing screening requirements and direct-from-physician dispensing of mifepristone was intended to lift barriers to access for patients.
“The in-person dispensing requirement prevented patients from meeting with providers remotely from their homes, thereby imposing on patients costs and logistical burdens associated with travel,” reads the Food and Drug Law Scholars brief.
Marsha Henderson, a former associate commissioner for women’s health at the FDA, told reporters ahead of oral arguments that she was deeply involved in the initial approval of mifepristone and the 2016 deregulation of the product.
Henderson denied any involvement of politics in determining the safety and efficacy of mifepristone or the brand name product, Mifeprex.
“I will say, as it relates to the safety and effectiveness of the drug, I do not believe that it was influenced by politics,” Henderson said. “Some of the other issues perhaps but not the labeling of the product.”
Although the FDA’s main argument before the Supreme Court in the case, FDA v. Alliance for Hippocratic Medicine, is that the physicians suing the agency over its decision to deregulate mifepristone do not have standing to sue in court, the agency also argues that the agency’s actions were entirely lawful and based on scientific evidence.
The agency argues that it used 15 years of safety and efficacy data in making the deregulation decision in 2016. Even after changes to reporting requirements for adverse events, the FDA contends, the efficacy and safety standards for mifepristone are the same as other pharmaceuticals.
“While FDA changed the reporting requirements, it did not eliminate them,” reads the FDA’s argument to the Court from November when asking to review the case. “Indeed, mifepristone is subject to reporting requirements at least as stringent as ‘the vast majority of other drugs.'”
The Food and Drug Law Scholars assert that only 32 other drugs on the market follow the same adverse reporting requirements that mifepristone did before 2016.
To make both the 2016 and the 2021 changes, the FDA says it relied on all adverse complications data already collected by reports to the FDA Adverse Event Reporting System, or FAERS. Any individual can report any complication to the FAERS database, and adverse complication reports are not verified by the FDA.
Both FDA and Danco Laboratories, the makers of Mifeprex, also argue that they also relied on post-market research and scientific literature demonstrating its efficacy.
Several studies on the risks and potential harms of medication abortion have faced threats of retraction following the recent legal developments that have challenged mifepristone’s FDA approval status.
Two papers written by James Studnicki and colleagues affiliated with the American Association of Pro-Life Obstetricians and Gynecologists were retracted in February by Sage Journals, a major academic publishing house.
Sage justified the drastic measure of retraction by saying that the authors did not disclose their affiliations with the anti-abortion think tank the Charlotte Lozier Institute, funded by SBA Pro-Life America, despite the fact that the organization was heavily mentioned in the body of the paper.
Using data from states that cover abortion through Medicaid, the studies found that a patient was 22% more likely to visit the ER for any reason after a chemical abortion compared to a surgical procedure.
The researchers also found that more than 60% of abortion-related emergency room visits in 2015 were incorrectly coded as spontaneous miscarriage when, in reality, the patient was experiencing complications from a medication abortion, which may be a risk factor for subsequent hospital admission or surgery.
These papers, published in 2021 and 2022, were cited by Texas District Judge Matthew Kasmaryck in his initial ruling that overturned the entire FDA approval of mifepristone in April 2023. The papers were also referenced by the three-judge panel of the 5th U.S. Circuit Court of Appeals when they ruled to keep the initial 2000s approval but revoked all changes made past 2016.
Other studies have also found high rates of complications with mifepristone abortions.
In 2009, the journal Obstetrics and Gynecology published a study on the complication rate of mifepristone abortions in Finland compared to surgical abortions performed in a clinic or hospital setting. The study found that the “overall incidence of adverse events was fourfold higher in the medical compared with surgical abortion cohort.”
Researchers found that over 15% of medication abortion patients experienced hemorrhaging compared to in-clinic patients. Nearly 7% of self-managed patients experienced an incomplete abortion compared to only 2% of in-person procedures.
Alliance Defending Freedom senior counsel Jim Campbell, who represents AHM, previously told the Washington Examiner that the retracted studies should not harm their argument for the court to uphold the 5th Circuit’s decision.
“You don’t need those studies to win the case,” Campbell said. “All we need to win the case is the FDA’s own words and the studies cited and relied upon by the FDA.”