A large body of research has shown the medication to be safe and overwhelmingly effective. But advocates on either side of the abortion debate in the United States have been at war over access to the drug since its development in France more than three decades ago.
Now, antiabortion groups galvanized by the U.S. Supreme Court’s overturning of Roe v. Wade last year are challenging health regulators’ decades-old approval of mifepristone before a judge known for his antiabortion views. A decision in their favor could at least temporarily make it difficult, if not impossible, for Americans to access the drug at a time when medication-induced abortions have surpassed surgeries as the most common way to end a pregnancy.
Here is a list of milestones in the history of mifepristone, from its invention to the lawsuit underway now.
1980-1984: French scientists create mifepristone
Mifepristone was first synthesized by researchers at the French pharmaceutical company Roussel-Uclaf in 1980. Endocrinologist Étienne-Émile Baulieu wanted to “give women a choice that, through a pill, respects their privacy and physical integrity and allows them to totally avoid the aggression of surgery,” as he told the New Yorker in 2022. He proposed creating a molecule that would block the hormone progesterone, without which the uterus can’t retain a fertilized egg.
The idea was a success, and clinical trials for the pill, known then as RU-486, began in Switzerland in 1982. Eighty-five of the 100 women who took the drug had complete abortions, according to a mifepristone history published by the National Academy of Sciences. The effectiveness was boosted to 96 percent when the medication was combined with compounds called prostaglandins that induce uterine contractions.
1988: Mifepristone is approved in France
Fall of 1988 marked the beginning of a tumultuous battle to bring mifepristone to market.
That September, French authorities cleared the drug for use up to seven weeks of pregnancy. The decision was met with protests, boycott threats and violence from antiabortion extremists, who at one point set fire to a Paris movie theater. Within weeks of approval, Roussel-Uclaf reversed course and pulled the drug.
Almost immediately, however, physicians and abortion rights groups began pushing back, mobilizing protests and boycotts of their own. The French government, which owned a stake in Roussel-Uclaf, threatened to transfer the drug patent if the company didn’t resume distribution. Days later, Roussel-Uclaf executives put mifepristone back on the market.
The French health minister said at the time: “I could not permit the abortion debate to deprive women of a product that represents medical progress. From the moment Government approval for the drug was granted, RU-486 became the moral property of women, not just the property of the drug company.”
1989: The United States bans the import of mifepristone
Under pressure from conservative lawmakers, the U.S. Food and Drug Administration banned the import of RU-486 in June 1989. For a brief period before that point, it may have been possible for some patients to get the drug through French doctors. But the FDA commissioner claimed in a letter to Rep. Robert Dornan, a Republican from California, that the drug could “present unreasonable safety risk.”
The import ban didn’t just affect women seeking medication abortions. It also curtailed research into other conditions unrelated to pregnancy. Scientists who used the drug to study breast cancer and Cushing’s syndrome told members of Congress that they had to halt their work in part because they could no longer receive supplies of the drug by mail.
1990s: Mifepristone becomes available in parts of Europe and China
Other countries soon began to green-light RU-486. China was an early adopter of the drug, though the Roussel-Uclaf didn’t market it there right away. In 1991, British authorities granted it full approval, followed by Sweden in 1992.
In the United States, public interest in the pill rose, and the political fight over access heated up. Abortion rights organizations made RU-486 availability a key part of their platforms. Physicians groups were on board, too, with the American Medical Association voicing support for testing and use of RU-486. Antiabortion groups and conservative lawmakers fought to maintain the ban.
1994-1999: Clinical trials are conducted in the United States
After President Bill Clinton took office in 1993, his administration pushed Roussel-Uclaf to donate its patent for RU-486 to the Population Council, a nonprofit contraceptive research organization that offered to run clinical trials in the United States. They finalized an agreement in May 1994, at which point testing began.
In 1996, the Population Council presented its findings to an FDA panel, which recommended approval, as the New York Times reported in a 2000 story on the pill. But there was one major hang-up: the nonprofit couldn’t find a company to manufacture it. “Lobbied vigorously by conservative investment funds, virtually all of the major U.S. pharmaceutical companies, including Teva, Merck, Abbot Laboratories, Johnson & Johnson and Phamarmacia & Upjohn, are said to have declined to either produce or distribute mifepristone,” the Times reported.
2000: The FDA approves mifepristone
The years-long regulatory limbo ended when a company called Danco was formed exclusively to market mifepristone in the United States. The FDA approved the drug in September 2000, more than a decade after it was brought to market in France.
Gloria Feldt, president of the Planned Parenthood Federation of America, called it at the time “the most significant technological advance in women’s reproductive health care since the birth control pill.”
Drug regulators said the pill could be used to end pregnancies up to seven weeks after a woman’s last menstrual period.
The drug is the first step in a two-drug regimen for patients who want an abortion. Up to about 48 hours after taking mifepristone, the patient takes a dose of misoprostol, which brings on contractions that expel fetal tissue.
2016: The FDA authorizes mifepristone for up to 70 days gestation
Following mifepristone’s approval, medication-induced abortions gradually gained popularity. By 2015 they accounted for about a third of all abortions performed in the United States, according to the Guttmacher Institute, a reproductive rights organization.
In 2016, the FDA opened the door for broader use of mifepristone. After reviewing safety data, the agency said the drug could be used to end pregnancies of up to 10 weeks. The move doubled the number of abortions eligible for the drug, according to the Guttmacher Institute.
2019-2022: Mifepristone access expands again, but challenges emerge
The FDA approved a generic form of mifepristone in 2019. The drug is manufactured by a single company, GenBioPro.
In the early months of the coronavirus pandemic, medical groups filed a federal lawsuit seeking to lift a long-standing requirement that patients get mifepristone in person from a medical provider. A judge sided with them in fall 2020, but the Supreme Court later reinstated the rule. Shortly after President Biden was elected, his administration said it wouldn’t enforce the in-person requirement during the pandemic; officials later made the policy permanent.
As of 2020, medication abortions accounted for more than half of all facility-based abortions in the United States, the Guttmacher Institute reported last year — the highest proportion ever.
In June 2022, the Supreme Court overturned Roe v. Wade, ending the fundamental right to abortion established nearly a half-century prior. States passed a flurry of laws restricting abortion or banning it entirely.
2022: Mifepristone’s FDA approval is threatened
In November 2022, Alliance Defending Freedom, a Christian legal advocacy organization, sued in federal court in Amarillo, Tex., on behalf of several antiabortion medical groups and doctors to reverse the FDA’s approval of mifepristone. They alleged the FDA lacked authority to approve the drug and didn’t adequately study it. Public health officials and prominent medical associations reject those claims, citing the drug’s well-documented safety record.
Many providers say they will continue to offer medication abortions using only misoprostol if U.S. District Judge Matthew Kacsmaryk suspends FDA approval of mifepristone. A misoprostol-only procedure requires three doses of four pills each. That protocol is widely used around the world, but studies show it is less effective than the two-medication regimen, and usually causes more cramping and bleeding.
Clinics also could limit their offerings to surgical abortions, which require far more time and resources than pills. Experts say that overseas organizations most likely will continue to ship generic mifepristone from India to consumers in the United States.
Never before has a federal court ordered the government to revoke approval of a drug over objections from the FDA and the manufacturer. Such a reversal, a group of leading medical associations wrote in a recent brief, would “cause profound and irreparable harm to patients across the country.”