Updated on March 19, 2024: 

Several points in the analysis have been updated to reflect the latest data from Guttmacher’s Monthly Abortion Provision Study, including the share of abortions in the formal US health care system in 2023 that were medication abortions and estimates of the total number of abortions obtained in the formal US health care system in 2023.  

Almost two years after the US Supreme Court made the decision to overturn Roe v. Wade, the Court will hear another major case on March 26 that could reshape the abortion access landscape. Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA) is a groundless lawsuit brought by abortion opponents in an attempt to overturn the FDA’s approval of one of the two drugs used for medication abortion.

The plaintiffs’ case—which is based on unsound science and misinformation—could dramatically reduce access to mifepristone, which is used in the most common medication abortion regimen in the United States. Access to mifepristone remains unchanged until the Supreme Court issues a decision, but the stakes are high.

Whether you’ve been following this case since the beginning or are new to the issue, here are eight key points to know about the case and its potential impact.

1.  In late 2022, an anti-abortion group launched a baseless lawsuit challenging FDA approval of mifepristone that has worked its way to the US Supreme Court.

• The original goal of the plaintiffs was to have mifepristone withdrawn from use and failing that, to force the FDA to reinstate the outdated and unnecessary restrictions that originally constrained its use. The plaintiffs relied on low-quality science about the safety and effectiveness of medication abortion to make their case.
• The plaintiffs in this case went “judge shopping” with the goal of bringing the case in front of a judge with well-known anti-abortion views. That Texas federal court judge’s decision attempted to rescind the FDA’s approval of mifepristone in 2000. In line with how low-quality science has been used throughout this case, two of the studies cited in the ruling were retracted by the academic journal publisher in February 2024 because of a “lack of scientific rigor.”
• The Texas court decision was appealed to the Fifth Circuit Court of Appeals, well-known to be hostile to abortion rights. The Fifth Circuit instead reinstated burdensome regulations on mifepristone.
• Those Fifth Circuit restrictions were temporarily blocked from going into effect by the US Supreme Court and mifepristone remains available under the current regulations. Access would be curtailed if the Supreme Court upholds the Fifth Circuit ruling or limits access to the drug in other ways. The case will be heard on March 26 and a decision is expected by early summer. 

2.  The target of the plaintiffs’ case—mifepristone—is one of two drugs used in the most common abortion method in the United States.

• Mifepristone is a pill that is used along with misoprostol in the most common medication abortion regimen. In 2023, medication abortions accounted for 63% of all abortions in the formal US health care system. This is an increase from 2020, when medication abortion accounted for 53% of all abortions. 
• The FDA approved mifepristone for use in the United States in 2000. It is now approved for use up to 10 weeks of pregnancy, although research shows provision beyond 10 weeks is safe and effective and some providers administer it after that point.
• Despite overwhelming evidence of its safety and efficacy, mifepristone has been unnecessarily restricted. When the FDA originally approved mifepristone, the agency restricted how the drug could be prescribed and dispensed, despite substantial evidence those restrictions were not medically necessary.
• In line with the medical evidence, the FDA first suspended in-person dispensing in 2021, then ended the requirement in January 2023, allowing mifepristone to be mailed to patients in many states. At the same time, the FDA permitted retail pharmacies to get certification to dispense mifepristone, although the extent to which they are doing so remains unclear. Major pharmacy chains CVS and Walgreens announced in early March 2024 that they plan to dispense mifepristone soon in a limited number of states.

3.  Evidence from around the world also demonstrates mifepristone’s safety and efficacy.

• Nearly 100 countries have approved the use of mifepristone, and Guttmacher researchers found that medication abortion (typically the dual regimen of mifepristone and misoprostol) accounted for at least half of all abortions in the majority of high-income countries with available data. 
• The World Health Organization (WHO) has included mifepristone and misoprostol in its model list of essential medicines for national health systems to stock since 2005.
• In 2019, WHO elevated the status of mifepristone and misoprostol, classifying them as “core” medications for basic health care systems that can be provided without specialized training and should be available at all times.

4.  Any court decision that reimposes medically unnecessary restrictions on mifepristone would cause major disruptions to abortion provision and further limit patients’ options.

• The two-drug combination of mifepristone and misoprostol accounts for more than 98% of medication abortions in the United States (as of 2020).
• Using solely misoprostol is also a medication abortion regimen supported by leading professional and medical organizations in the United States and around the world. However, the combined regimen is more effective than use of misoprostol alone.
• It is unclear how widely a misoprostol-only protocol might be offered by abortion providers if mifepristone provision were restricted further or to what extent it would be taken up by patients, whose choice in protocol should not be dictated by judges or politicians.

5.  The new Supreme Court case on mifepristone takes place against a backdrop of other changes in the US abortion access landscape since the fall of Roe in 2022.

• Fourteen states are enforcing total abortion bans, with many other states imposing severe restrictions on abortion access.

• Data from Guttmacher’s Monthly Abortion Provision Study show substantial increases in the number of abortions from 2020 to 2023 in states that border those where abortion is banned. 

• Guttmacher’s study also shows the total number of abortions provided nationally in 2023 substantially exceeded 2020 numbers (the latest year of data before Roe was overturned) and is the highest number measured in the United States in over a decade. 

• Self-managed abortions are those that take place outside the formal health care system, and in the United States, typically involve use of medications. Self-managed medication abortion has been increasing in the past several years, although precise estimates are not yet available. People who self-manage may use the combined mifepristone-misoprostol regimen or misoprostol-only method; it is unclear how any additional restrictions on mifepristone would impact these practices.

6.  Any additional restrictions on mifepristone would intensify existing racial and socioeconomic divides that shape who can access abortion care.

• All abortion restrictions and bans disproportionately impact marginalized groups, as they increase the financial and logistical costs of obtaining an abortion and push care further out of reach for those who do not have the means to overcome these costs.
• Research from 2022 shows Black individuals and those with incomes below poverty level are less likely than White, Asian and Hispanic respondents and those with family incomes above poverty level to have a medication abortion, even after taking individual preference into account.
• If medication abortion using mifepristone becomes less accessible, demand for procedural abortions could increase substantially, leading to increased wait times for patients and strain on clinic capacity, which would also likely result in inequitable impacts.  

7.  Reinstating any past restrictions on mifepristone would also threaten the FDA’s authority and the process for regulating new and approved drugs.

• If courts can second-guess and undermine FDA approvals and regulatory decisions, that would upend the current process for drug approval and regulation and potentially endanger health and safety more broadly.
• Any decision by the Supreme Court that overrules the FDA’s decisions would also set a precedent for additional politically motivated interference on other therapies or medications, including certain methods of contraception, vaccines or drugs that rely on stem cell research.

8.  Policymakers at all levels can do their part to protect and expand access to all methods of abortion care, including medication abortion using mifepristone.

• The EACH Act would ensure coverage for abortion—no matter how much someone earns, their type of insurance or where they live.
• The Women’s Health Protection Act would reinstate some protections for abortion access by establishing a right under federal law to deliver and receive abortion care, including medication abortion, without medically unnecessary restrictions and bans before the point of fetal viability.
• The Abortion Justice Act includes provisions that support the full spectrum of care around abortion services.
• State-level policymakers must pass legislation that expands and protects access to abortion, including enshrining the right to abortion in a state constitution.

Only One Reasonable Path Forward for the US Supreme Court

The Supreme Court has only one reasonable option in this case—honor the FDA’s evidence-based decisions on mifepristone and preserve access to medication abortion without any medically unnecessary restrictions. Anti-abortion activists’ endgame was never solely to overturn Roe—it has always been to ban all abortions nationwide. Restricting medication abortion is part of that larger strategy.

With 14 states enforcing total abortion bans and many more restricting access in other ways, it is important to remember that these attacks on bodily autonomy consistently fall the hardest on people and communities with few financial resources and those marginalized by systemic racism. As the Supreme Court considers the facts about mifepristone’s safety and efficacy, maintaining full access to this critical drug is the only tenable outcome.