Mifepristone is now at the center of the fight over abortion. Why was it created and approved? Here's everything you need to know:
What's the pill's origin?
In 1970, French endocrinologist and biochemist Étienne-Émile Baulieu had an idea for an "unpregnancy pill" that could induce abortions. Such a pill, he thought, would enable women to avoid surgery and end pregnancies in private. Baulieu knew the hormone progesterone was essential to pregnancy and began searching for "an anti-hormone" that would block progesterone. His idea came to fruition in 1980, when a French drug company created mifepristone, then called RU-486. In 1988, the pill was approved in France. More than a dozen countries followed, and in 2000, the FDA approved mifepristone for use for up to seven weeks into a pregnancy in the U.S. Baulieu said he hoped "the 'abortion pill' might even help eliminate abortion as an issue." But after the U.S. Supreme Court overturned Roe v. Wade last year, enabling states to outlaw abortion, mifepristone became a new battleground for the same reason Baulieu sought to create it: It enables women to end pregnancies in their own homes. A federal judge with a long history of anti-abortion activism recently ordered the Food and Drug Administration to revoke its approval; that ruling has been stayed and is likely to be ultimately decided on appeal to the Supreme Court.
How does it work?
Mifepristone blocks progesterone, a hormone that prepares the uterus to receive and carry an embryo. The drug latches onto receptor molecules in place of progesterone, causing a miscarriage. In the U.S., mifepristone is usually followed by a second pill, misoprostol, 24 to 48 hours later, which causes contractions that empty the uterus. Misoprostol — which isn't currently at risk of being taken off the market — can be used alone to induce an abortion. However, it's only 87 to 93 percent effective on its own, compared with 95 to 99 percent when combined with mifepristone.
How was the drug approved?
During the 1980s and '90s, the U.S. banned the importation or manufacture of RU-486. But in 1994, the French pharmaceutical company Roussel Uclaf donated all rights for mifepristone in the U.S. to the Population Council, which licensed it to Danco Laboratories. The company undertook years of clinical trials and applied to the FDA for approval, which was fiercely opposed by anti-abortion groups. "We're really very simplistic, visually oriented people," said Dr. John Willke of the National Right to Life Committee at that time. "If what [mifepristone] destroys in there doesn't look human, then it will make our job more difficult." In 2000, based on a review of three rounds of safety data over four years, the FDA approved mifepristone's use in abortions.
How widely used is it?
In recent years, the FDA has expanded access to the drug and approved it for use at home and via telemedicine.
In 2016, the FDA broadened its use through up to 10 weeks of pregnancy. This year, it dropped a rule against retail pharmacies dispensing it with a prescription. Medication abortions are now more common than surgical procedures: In 2020, 53 percent of the country's 930,160 abortions used pills, up from 39 percent in 2017. Mifepristone is now available in at least 94 countries.
Is it safe?
It's safer than most drugs and pregnancy itself. Since the original FDA review process, over 100 studies have since confirmed that mifepristone is safe and effective, and millions of women have used it. No drug is totally without risk, but data on mifepristone show only five deaths for every 1 million uses — a lower rate than Tylenol, Viagra, or penicillin. In fact, penicillin's risk of death is four times greater, while Viagra's is almost 10 times greater. Federal judge Matthew Kacsmaryk nonetheless ruled last month that the FDA's 23-year-old approval of mifepristone should be rescinded, and echoed claims by anti-abortion groups that it's unsafe and causes many women to feel regret and suffer mental health issues. "Instead of relying on the mountain of evidence demonstrating safety, the court turned to anecdotes from anti-abortion advocates and blog posts," said Ushma Upadhyay, professor of obstetrics and gynecology at the University of California, San Francisco. "That's not how scientific research works."
Why is its safety at issue?
Abortion groups know it's the only way to challenge mifepristone's continued availability, which makes it very difficult for states to truly stop abortions. After the Supreme Court overturned Roe v. Wade last summer, 14 states banned abortion without exceptions and dozens of clinics closed. Since the pill can be mailed or transported across state borders, it became critical to pro-choice groups' efforts to keep abortion accessible in the post-Roe era. Mifepristone, Jia Tolentino said in The New Yorker, is one of the principal reasons "we are not going back to the era of coat hangers."
Abortion's underground railroad
After the Supreme Court's Dobbs v. Jackson ruling, mifepristone was banned in states that criminalized abortion. Activists quickly developed underground networks to deliver pills to women. The Mexican nonprofit Las Libres has been getting up to 100 requests a day from activists in the U.S. Older American expats who easily cross the border without suspicion carry the pills to Texas, where providing the tools for an abortion is a felony. Another organization called Just the Pill plans to dispatch mobile-abortion clinics to the borders of Colorado, New Mexico, and Illinois, so they can provide pills and surgical abortions to women in states where abortion is illegal. Perhaps the most well-known organization delivering mifepristone by mail is Aid Access, run by Dutch physician Rebecca Gomperts. Aid Access conducts online consultations and then sends a prescription to a pharmacy in India, which ships the pills directly to the patient. Gomperts says maintaining access to abortion is a matter of "social justice," adding, "Unjust laws should not be respected." After the Dobbs ruling, requests to Aid Access for mifepristone tripled to 254 a day, and have surged again since the federal judge's ruling in Texas, even though it has been stayed. Medication abortions are "definitely safer than giving birth," Gomperts said, "so the arguments that are being used are so outrageous, anti-scientific, it scares me."
This article was first published in the latest issue of The Week magazine. If you want to read more like it, you can try six risk-free issues of the magazine here.