On 26 March, the US Supreme Court will hear oral arguments in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (AHM vs. FDA), which the Guttmacher Institute describes as 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”. Their case against mifepristone is based on unsound science and misinformation. It could dramatically reshape the US abortion access landscape once again. The Guttmacher analysis includes the following key points:
- Evidence from around the world demonstrates mifepristone’s safety and efficacy.
- Nearly 100 countries have approved the use of mifepristone for abortions. 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.
- 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 specialised training, and should be available at all times.
- 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.
- Any additional restrictions on mifepristone would intensify existing racial and socioeconomic divides that shape who can access abortion care.
- 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.
- Reinstating any past restrictions on mifepristone would also threaten the FDA’s authority and the process for regulating new and approved drugs.
Access to mifepristone remains unchanged until the Court issues a decision, which is expected by early summer 2024. Guttmacher concludes: “As our analysis makes clear, the Court’s only reasonable option in this case is to maintain full access to this critical drug.”
SOURCE: Guttmacher Institute, by Kelly Baden, Rachel K Jones, Isabel Guarnieri, 11 March 2024