Mifepristone for Abortion in a Global Context: Safe, Effective and Approved in Nearly 100 Countries

In late 2022, US anti-abortion groups filed a baseless lawsuit to revoke approval by the US Food and Drug Administration (FDA) of mifepristone, one of two drugs widely used to end an early pregnancy. These anti-abortion groups attempted to spin a false narrative that has been widely debunked by scientists and medical authorities and is contradicted by the reality of decades of medication abortion provision in the United States and around the world. The case, Alliance for Hippocratic Medicine v. FDA, is working its way through federal court proceedings, and any decision will likely be appealed to the US Supreme Court.

Claims that question the safety of mifepristone fly in the face of extensive evidence demonstrating the drug’s safety since it was approved by the FDA in 2000. And evidence on its use and safety in the United States is just the tip of the iceberg: Mifepristone has been around for nearly 40 years, and there is abundant evidence from other countries, as well as from the global scientific community, that it is safe and effective and, in fact, protects women’s health. 

Approved and Commonly Used in Nearly 100 Countries

Mifepristone is used in a two-drug abortion regimen that has proven safe and effective in numerous studies worldwide. It blocks the hormone progesterone, which is needed for a pregnancy to continue; misoprostol, the second drug in the regimen, then causes uterine cramping to expel the pregnancy. Mifepristone was first approved in France and China in 1988, and as of May 2023, 96 countries have approved its use. The World Health Organization (WHO) abortion care guidelines recommend combined use of mifepristone and misoprostol, or use of misoprostol alone, as safe and effective methods of ending a pregnancy.

Drawing on 2017 evidence for 24 high-income countries, Guttmacher researchers found that medication abortion (typically mifepristone and misoprostol together) accounted for at least half of all abortions in the majority of high-income countries. In Finland, Sweden and Norway, medication abortion accounted for about nine out of every 10 abortions. The study also found that the proportion of abortions using medication increased steadily over time in the 11 countries that had trend data. A 2021 study found the proportion of all abortions done with medication ranged from 87% to 98% in five Nordic countries.

Routinely Used Beyond 10 Weeks

While the US FDA has approved mifepristone for use only through 10 weeks of pregnancy, other countries allow access to the medication later into pregnancy. This provides a longer window for pregnant people to reap the benefits of this safe and effective method. Indeed, in 2017, medication abortion accounted for 78% of abortions performed between nine and 12 weeks’ gestation in Sweden, as well as 68% of those in Norway and 29% of those in England and Wales.

Considered Essential Medicine by the World Health Organization

Mifepristone and misoprostol are recognized by WHO for decreasing the incidence of unsafe abortions—i.e., those performed using a method not recommended by WHO or by someone lacking the necessary skills—because the medications can be used to safely terminate pregnancies in settings where pregnant people may not otherwise be able to access appropriate care. By reducing a leading cause of maternal mortality worldwide, these drugs protect women’s health.

WHO maintains a model essential medicines list containing medications deemed important to health systems worldwide. Since 2005, WHO has included both mifepristone and misoprostol on this list, which is meant to provide guidance to countries in their own selection of essential medications. In 2019, WHO upped the status of mifepristone and misoprostol, classifying them as “core” essential medications for basic health care systems, a category comprised of “the most efficacious, safe and cost-effective medicines for priority conditions” that should be available in health care systems at all times. As of 2017, mifepristone was included in the essential medications lists of at least 16 countries.

Harmful Effects if the United States Bans Mifepristone

Medication abortion accounted for more than half of all US abortions in 2020, and more than 98% of these used a combined regimen of mifepristone and misoprostol. Although abortions can safely be performed with misoprostol alone, if mifepristone becomes unavailable, it is unclear whether all current providers using the two-drug regimen would offer abortion care using misoprostol alone and to what extent patients would take up this method. If use of misoprostol by itself did not fully replace the combined regimen, the demand for procedural abortions could increase—potentially leading to delayed care and logistical hurdles for many patients. This situation would play out within the current US landscape in which 13 states have banned abortion almost completely, leaving many people with fewer abortion options already. Lack of access to mifepristone may also mean that some abortion providers who currently offer only medication abortion would stop providing it altogether. In such a scenario, residents of 10 states could experience disproportionately large drops in the share of people living in counties with an abortion provider.

Furthermore, eliminating access to medication abortion with mifepristone could exacerbate existing racial and socioeconomic divides in access to abortion care. Mifepristone and misoprostol can be prescribed via telehealth in many areas, reducing costs associated with obtaining an abortion, such as transportation and child care, and allowing for more flexible scheduling. Abortion restrictions disproportionately impact marginalized groups, and the elimination of medication abortion with mifepristone as an option would further increase existing inequities in access to care.

United States Increasingly an Outlier as Other Countries Expand Abortion Access

Abortion is an experience shared by tens of millions of people around the world. According to recent estimates, 73 million abortions occur annually worldwide and 930,000 occur each year in the United States.

The US Supreme Court decision to end the federal constitutional right to abortion in June 2022 made the United States an outlier, bucking the decades-long global trend toward liberalizing abortion laws. Between 2000 and 2022, 50 countries have expanded the legal grounds for abortion, while only the United States and two other countries (Poland and Nicaragua) have rolled back abortion rights.

If the FDA’s long-standing approval of mifepristone is revoked, the United States will be an anomaly once again, by denying access to a medicine that has been deemed critical to public health by WHO and other global health experts and that has been approved for use in countries around the world.