When the U.S. Food and Drug Administration approved mifepristone 21 years ago, it was known as RU-486 and hailed as the most important advance in reproductive health since the birth control pill. Time magazine had called it “The Pill That Changes Everything.” It was supposed to provide an attractive alternative to surgical procedures, which can involve sedation, a visit to a health-care facility, and obviously a great deal of medical expertise. At the time, the abortion battleground was, by and large, women’s health clinics. The pill, in theory, could allow women to bypass clinics, and throngs of protesters, almost entirely.

Yet in the two decades since FDA approval, mifepristone has failed to reach liftoff. If anything, it’s receded from view. A labyrinth of regulatory restrictions has kept it intentionally out of reach. Most abortions in the U.S. are still done by surgical procedure, even though the majority of people ending their pregnancy do so early enough to take the pill instead. Almost 80% of adults, including two-thirds of women, don’t even know medication abortion exists, according to the Kaiser Family Foundation.

Jessica Nouhavandi, a pharmacist and the co-founder of online drug-delivery service Honeybee Health, was surprised to learn her friends were among them. At the beginning of the pandemic, she decided she wanted to sell the pill through her site. When she mentioned it in a group text with friends, not one of the 10 college-educated, thirtysomething women had ever heard of an abortion pill. Even among her colleagues, she sees how this could happen. “In pharmacy school you don’t really learn about medication abortion,” she says. Her training didn’t entirely ignore the drug involved; there was just very little emphasis on what it was used for. “Basically, we learn about the meds but don’t talk too much about medication abortion.”

Nouhavandi felt driven to do something about it, though it wasn’t clear much could be done. For as long as the abortion pill has been on the market, the FDA has required it to be given at a doctor’s office. That’s not the only quirk specific to mifepristone, either. Prescribers have to get certified to dispense the pill and then counsel patients on the risks of taking it. They then have to get them to sign a form reiterating the facts that were just told to their faces.

These rules may sound largely procedural, but they’re logistical headaches that don’t apply even to some highly addictive drugs. Without them, a general practitioner could prescribe the pill via telemedicine and have it sent to their patients by mail. This would be particularly useful for the almost 9 out of 10 American women who live in counties without an abortion clinic.

For years, activists, health-care professionals, and medical researchers have been building a case that the abortion pill should be treated like other medications that come with similarly few medical concerns. With the U.S. on the precipice of a new era of restricted abortion access—the Supreme Court is hearing a lawsuit that could overturn Roe v. Wade this year—their cause is more urgent than ever.

The FDA last year reviewed its restrictions on mifepristone, but ultimately decided to keep all but one in place. Women no longer have to pick up the pill at a doctor’s office. That was a “huge win,” says Nouhavandi, but that the FDA left all of the other idiosyncratic hoops in place is “hugely disappointing.” Plus the agency added another: Pharmacies such as hers have to get certified to distribute the drug—a rule that only applies to 40 FDA-approved drugs, out of more than 19,000. There’s no certification process in place yet; creating one could take months. So far, Walgreens Boots Alliance Inc. isn’t seeking certification; CVS Health Corp. wouldn’t comment on whether it plans to do so. “I don’t think the fight is anywhere near over,” Nouhavandi says.

The story of the abortion pill is a revolution in fits and starts. RU-486 was first developed four decades ago by the French pharmaceutical company Roussel Uclaf. It works by blocking progesterone, a hormone that helps grow the uterine lining, where an embryo would typically implant. Early research found the drug, also known as mifepristone, was 80% effective at inducing an abortion. When combined with misoprostol, a drug that causes a uterus to contract, which helps expel a fetus, it works more than 95% of the time in early pregnancies.

In 1988, France became the first Western country to approve the pill for abortions. Within a month, anti-abortion protesters successfully pressured Roussel Uclaf to halt its distribution. The French health minister, Claude Évin, intervened and put it back on the market. “I could not permit the abortion debate to deprive women of a product that represents medical progress,” he said at the time. “From the moment government approval for the drug was granted, RU-486 became the moral property of women, not just the property of a drug company.”

But it was very much the property of a drug company—one that anti-abortion activists continued to relentlessly target. The National Right to Life organization, a U.S. anti-abortion nonprofit, wrote to the French ambassador threatening a global boycott of Roussel Uclaf and its parent company’s products. Roussel Uclaf, in turn, never marketed the pill to Americans. As the drug had made its way to China, Sweden, and Great Britain, neither the drugmaker nor the Republican administrations in charge in Washington had any will to bring it to the U.S.

Then an eight-year political window opened. Bill Clinton, who’d campaigned on making the abortion pill a reality for Americans, came into office. In one of his first moves, he asked for a review on an import ban on the pill. Over his two terms, the Population Council, a reproductive-health nonprofit that had secured the rights to market the drug from Roussel Uclaf, undertook clinical trials needed to get FDA approval and enlisted a drugmaker, Danco Laboratories, to produce the pills.

Danco’s origin story, and almost everything else about it, is intentionally vague. According to a Washington Post article from 2000, the “secretive and obscure” company was formed in the Cayman Islands in 1995. Danco makes no other medicine besides the abortion pill and keeps a low profile to this day. It lists no street address or phone number. It just uses a P.O. box.

When the FDA gave its regulatory blessing to the pill in September 2000, at the tail end of Clinton’s second term, the agency’s commissioner at the time said the decision was purely scientific, not political. And yet the FDA put substantial and extraordinary restrictions on the pill. Later on, they became part of what’s known as a risk evaluation and mitigation strategy, or REMS, a program meant to “ensure the benefits of the medication outweigh its risks.”

A spokesperson for Danco said at the time that the FDA directives were more onerous than what the company had expected given the safety profile of the drug. “It was a mix of medical caution and political naiveté that manifested itself in hypervigilance,” says Beverly Winikoff, president of Gynuity Health Projects, who worked for the Population Council on the pill’s approval. Winikoff says that fear of a political backlash had a heavy hand in guiding the FDA’s decision-making process. There was such palpable worry about violence from anti-abortion activists during the approval process that the agency didn’t disclose where it was holding its data-review meeting. Winikoff was told to go to a hotel, where she was picked up by a bus that took her to a secret location. “I think there was just a heightened fear about the credibility of the agency, about their own jobs as professionals, about being pilloried in the press,” she said of how the FDA handled the review process. “It was astounding to me that the regulatory mechanisms were so divorced from women’s lives.”

Over the past two decades, researchers and medical bodies have built a growing and compelling case that many, if not all, of the regulations are medically unnecessary. A 2013 paper reviewing abortion data for 45,000 women showed just 0.3% of patients who took the pill ended up hospitalized. The study’s authors concluded that abortion by pill is “highly effective and safe.” Even Jane Henney, who was leading the FDA at the time of mifepristone’s approval, came out in 2019 to argue against the REMS in a New England Journal of Medicine opinion piece that she co-wrote. Nearly two decades of use and additional research “clearly demonstrate that mifepristone is extremely safe and effective,” the authors wrote. “We believe that the distribution restrictions may no longer be appropriate.” Yet even in the face of this data, regulatory oversight hasn’t meaningfully changed. The FDA told Bloomberg Businessweek that after conducting a comprehensive review of published literature and data provided to the agency, it concluded that it was safe to remove the in-person dispensing requirement, “provided all the other requirements of the REMS are met, and pharmacy certification is added.”

Wells has seen firsthand how much easier things could be. While consulting on a research project in Ethiopia in 2014, she watched a colleague walk into a pharmacy with no prescription and leave 10 minutes later holding a packet with the abortion pill and instructions on how to use it. The box, bearing the name “Safe-T Kit,” was no bigger than a deck of cards and cost the equivalent of $7. “We’re standing there on the streets of this little town,” Wells says. “We looked at each other and said, ‘How is it available in Ethiopia, which is one of the most resource-poor countries in the world in respect to health care, but in the U.S. it’s restricted beyond reach?’ ”

In the U.S., getting the pill can require maneuvering comically complex situations. Graham Chelius, a family medicine doctor on the Hawaiian island of Kauai, which has no abortion clinic, had to send his patients to Oahu—a 40-minute flight each way, costing $150 round trip, at least—just to pick up mifepristone from a certified provider. “There’s no other medicine that I provide that I have to have in the clinic that you just can’t write a prescription for and have it shipped,” Chelius says.

It was in the back-and-forth over Chelius’s suit that the FDA finally decided the pill could be distributed by mail. But he and the ACLU want the other constraints removed, too, and have yet to drop their case. “We urge the FDA to further eliminate unjustified and unscientific barriers to care,” says Julia Kaye, the lead ACLU attorney on the case.

The FDA “clearly could’ve gone farther,” says Daniel Grossman, director of Advancing New Standards in Reproductive Health at the University of California at San Francisco. Grossman has spent years churning out research on the safety of the abortion pill and sees things like the patient agreement form and the requirement that providers get a special certification to prescribe the pill as redundant to the very practice of medicine. Doctors already take responsibility for evaluating patients’ eligibility for medications; the extra paperwork doesn’t confer any added safety benefit, he says. “The pieces that are left of the REMS seem almost silly.”

Last fall, the conservative majority on the Supreme Court signaled in oral arguments that they’re open to eroding abortion protections. The court could entirely overturn Roe v. Wade, which would leave it up to states to set their own abortion laws. Many have bans ready to go if that happens. Or it could allow for earlier limits to abortion; right now states can’t prohibit abortions up until the “point of viability,” which the Supreme Court has said is around 23 to 24 weeks of pregnancy. The court could also keep the status quo.

Even in that case, treating mifepristone like any other drug would make abortions much easier to get, particularly for people who live far from clinics. Since 2015 more than 100 independent clinics have closed across the country, according to the Abortion Care Network, largely because of laws that make it excessively expensive or legally impossible for them to operate. The farther a woman lives from a clinic, the more likely she is to seek out mifepristone—even with the FDA’s hurdles. A 2021 study looking at about 57,000 abortions in almost 80% of the country’s counties showed that a 47-mile increase in distance to the nearest clinic was associated with a 41% increase in the use of telemedicine and medication abortion.

Conservative lawmakers know the power of this pill: Nineteen states have banned using telemedicine to get a prescription for it by requiring a clinician to be physically present when the drug is being given, according to the Guttmacher Institute, a reproductive rights research group. And more mifepristone-specific laws keep coming. A new Texas law threatens anyone who prescribes the abortion pill through telehealth and mails it with jail time and a fine of up to $10,000. Georgia is attempting to ban sending it by mail, too. South Dakota Governor Kristi Noem issued an executive order that required three trips to the doctor for a medication abortion. “The Biden administration is working right now to make it easier to end the life of an unborn child via telemedicine abortion,” she tweeted in September. “That is not going to happen in South Dakota.” (A judge put an injunction on the rule, for now.)

A Massachusetts case may provide some answers. When the FDA approved the powerful, long-acting opioid Zohydro in 2013, the governor tried to ban the sale of the drug in his state. The drug’s maker sued, and a U.S. district judge ruled that the state did not have the authority to overstep the FDA. Donley thinks this could provide the framework for a legal argument against state bans on mail-order abortion pills. If it works, it could also mean the pill remains available in places that ban abortion altogether. “This idea that the states can’t do something that frustrates the purpose of federal law, that’s the strongest way to go at mifepristone,” Donley says. There’s no guarantee it’ll work, but she thinks it’s worth a shot.

“The anti-abortion movement has been trying these pretty outlandish strategies on so many different fronts for decades, and a lot of times they fail, but sometimes they don’t. And now we are where we are,” she says. “It’s time to get creative.”