A Supreme Court ruling in April 2023 temporarily preserved access to the abortion drug mifepristone, which is used in the majority of abortions in the United States, and sent the case back to federal court. On Tuesday, the issue returned to the Supreme Court, with justices considering oral arguments regarding the Food and Drug Administration’s approval of the drug more than 20 years ago.
The sheer fact of the legal battle over the drug places the United States in a unique position relative to much of the world when it comes to reproductive health. This legal uncertainty, just years after the court eliminated the right to abortion established by Roe v. Wade, runs counter to one of the most striking global trends of recent decades on approved approaches to abortion: the rapid, widespread acceptance of medication abortions performed with mifepristone, often taken in combination with the drug misoprostol.
In 1988, France and China became the first countries to authorize the use of mifepristone. Thirty-six years later, at least 94 countries have approved the drug to some degree, according to Gynuity Health Projects, a reproductive health research organization that seeks to improve access to abortion. The group used World Health Organization data, government websites and its own research to track regulatory approval of the drug over time.
In no case other than in the United States — in a 2023 federal-court decision in Texas that the Supreme Court has since paused — has a country authorized use of the drug and then gone on to rescind it, said Gynuity President Beverly Winikoff, a professor of clinical population and family health at Columbia University.
The U.S. Food and Drug Administration approved mifepristone for limited use in 2000, a year after many European countries did. Since then, at least one new country a year has approved it, according to the Gynuity data.
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The FDA has broadened access to mifepristone over the years as evidence of its efficacy and safety has increased, approving it for use at home. Regulatory agencies abroad have done the same, and the WHO has come to recommend it and list it as an essential drug.
Britain was the third country to approve the drug, in 1991. By 2021, the percentage of abortions carried out by medication alone, as opposed to surgical procedures, in England and Wales had risen to 87 percent, according to government figures.
Argentina, which legalized abortion at the end of 2020, is the latest country to approve the drug. An Argentine pharmaceutical company, with support from the Buenos Aires Health Ministry, has plans to open Latin America’s first mifepristone factory.
The court decision in Texas ran counter not just to hundreds of scientific studies in the United States but to rapidly codified perspectives in the global health community, which over time has continued to move toward wider access.
In 2002, the WHO first advised the use of abortion pills, but only under the guidance of a physician who would be available in case of complications. In 2005, it added the pills to a list of secondary essential medications that the agency recommended governments provide. The pills have since migrated to the WHO’s primary list of essential medications. By 2022, the WHO had endorsed telemedicine, when available, as a safe option for self-managed abortions.
Mifepristone approval on paper, however, does not necessarily mean that access is widespread, said Bela Ganatra, who heads the WHO’s unit for prevention of unsafe abortion. Rules restricting when a person can have an abortion and under what conditions vary considerably by country, and sometimes by state and province.
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When mifepristone is available, the drug is taken along with misoprostol, which is also used to treat postpartum hemorrhages and gastric ulcers, among other conditions.
Misoprostol is much more widely available and affordable than mifepristone, even in countries that ban or heavily restrict abortions.
When mifepristone is not available, as is often the case in low-income counties, the WHO recommends misoprostol alone. Despite mifepristone’s growing recognition as part of an effective protocol for medication abortions, a misoprostol-only dosage still remains the norm in many countries, said Guillermo Ortiz, senior medical adviser at IPAS, a global reproductive rights nonprofit.
One of the benefits of mixing mifepristone with misoprostol is that fewer total pills are required, an important factor in places where women are required to travel to a health facility for each dose, sometimes for days, said Ann Moore, principal research scientist at the Washington-based Guttmacher Institute, which advocates for reproductive rights. For some women, an abortion may be more painful and take longer with misoprostol alone, she said.
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While national and regional data is limited, Ganatra said, an increasing number of countries are putting misoprostol and mifepristone on their essential medications lists — which indicates government commitment to make the medications available.
In countries where abortions are banned or restricted but misoprostol is available, pills are smuggled to women seeking the procedure, Ortiz said. For years, clandestine networks of women across Latin America helped women illegally perform self-managed abortions with misoprostol, which is available either illegally or for non-abortion uses.
In Uganda, where abortion is generally illegal, pharmacies keep misoprostol locked up to prevent staffers from stealing it to use or pass along for abortions, said Moore.
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Not only is mifepristone safe and effective, said Ganatra, but access to safe abortion services lowers the rate of women turning to unsafe, and potentially life-threatening, illegal options. Globally, unsafe abortions are one of the leading causes of maternal death, according to the WHO.
But decisions like those in Uganda and the United States fall outside the direction of a clear global trend.
“As the laws in this country become more extreme and non-evidence based, the United States is becoming more of a pariah on the global stage” in terms of access to safe abortions using methods recommended by experts, said Moore. “Countries that may have previously [looked] to the United States as a role model are now looking at the United States askance and saying, ‘We can do better than that. This is what not what we know to be good for reproductive health.’”