The future of mifepristone, a crucial abortion drug, is currently in question as US courts consider a challenge brought by anti-abortion groups. Considering medication is the most common US abortion method, it is the most significant reproductive rights case to make its way through the courts since Roe v Wade was overturned in 2022.
The groups suing the Food and Drug Administration over its approval of the drug claim that the drug poses a threat to women and girls – contrary to scientific consensus – and should never have been approved by the FDA more than two decades ago. The FDA vehemently stands by its approval of the pill, with the Biden administration emphasizing the agency’s rigorous safety reviews of the drug.
So what’s the story of the drug, and how did we get here?
The history of mifepristone – a global perspective
In 1980, mifepristone was invented by French drug company Roussel Uclaf and was approved for market use in France in 1988. After its approval, following threats of boycotts and violence by US anti-abortion groups, Roussel Uclaf decided to suspend distribution of mifepristone for two days before the French government stepped in, ordering the drug back on the market.
“From the moment governmental approval for the drug was granted, RU-486 became the moral property of women,” said France’s then health minister Claude Evin in reference to mifepristone, shutting down anti-abortion groups’ protest.
The UK and China followed France in approving mifepristone in 1991 and Sweden’s 1992 approval came quickly after.
But while the Clinton administration had high hopes of also quickly approving mifepristone, the same pattern did not emerge in the US.
In 1993, on the 20th anniversary of Roe v Wade, Bill Clinton signed a host of executive orders in support of abortion rights, in one of his first acts as president. One of those orders directed the health secretary to review an import ban that had been imposed on the drug, to determine whether it had any basis. “It is time to learn the truth about what the health and safety risks of the drug really are,” Clinton said.
On that day, he was met by about 75,000 anti-abortion protesters, angered by the change of direction after years of anti-abortion policies during the Reagan years. It was a harbinger of times to come: a fraught, seven-year battle for approval, putting the US behind many of its European counterparts in the approval of a potentially life-saving drug.
In 1996, the FDA met for the first time to consider the drug’s approval. Concerned about the potential for violence, officials held the meeting under strict security requirements, using metal detectors and a rigid travel itinerary to keep violence at bay. Those attending the meeting were to be bussed in from a nearby hotel, and only camera crews were allowed to wait outside the meeting in the parking lot.
Fierce anti-abortion backlash continued, and the FDA continued to review evidence on the drug’s safety, while the rest of the world continued to move ahead in approving it. By 1999, Austria, Belgium, Denmark, Finland, Georgia, Germany, Greece, Israel, Luxembourg, the Netherlands, Norway, Russia, Spain, Switzerland, Taiwan, Tunisia and Ukraine had all approved mifepristone.
In 2000, mifepristone was finally approved in the US, for terminations through seven weeks of pregnancy. That time period was later extended, to 10 weeks of pregnancy in 2016. Until 2021, mifepristone could only be dispensed in clinics, medical offices and hospitals – even though countries such as Canada and Australia had begun lifting those kinds of restrictions years prior.
With lockdowns in place across the world, the US finally began reconsidering its dispensing restrictions in 2020 during the Covid pandemic. By April 2021, in response to mounting pressure, the FDA temporarily lifted its restrictions on mifepristone, allowing it to be sent in the mail. Those changes became permanent in December 2021. In 2023, the FDA announced that pharmacies could become certified to dispense mifepristone, lifting the strict requirements on who can dispense it.
The fifth circuit court of appeals, which is currently considering the future of mifepristone in the US, in April invalidated all of the FDA’s post-2016 actions to loosen restrictions on the drug. The supreme court temporarily blocked that decision, and mifepristone currently remains available in pharmacies and through the mail as the case proceeds.
Are abortion drugs safe?
The plaintiffs challenging the approval of mifepristone have claimed the FDA’s 2000 approval of mifepristone has put the safety of women and girls at risk.
In reality, years of research on tens of thousands of women has shown it to be safe and effective. Many point out that mifepristone is safer than Tylenol and Viagra, and have lambasted remaining restrictions on the drug in the US, even at a time when it is listed as an essential medicine by the World Health Organization.
Meta-analyses within the last decade, on almost 270,000 people using the drug through nine weeks of pregnancy, have consistently shown a less than 1% rate of serious complications associated with use of the drug (such as an infection, or need for a blood transfusion). Only two deaths have been reported in that subsample – one caused by pneumonia, and one from an ectopic pregnancy – both of which are listed as likely not the result of taking medication abortion pills.
The rise in use
Medication abortion only recently became the most common abortion method in the US. The most recent comprehensive data, from 2020, suggests that 53% of US abortions could be attributed to medication (both misoprostol and mifepristone used together). But that number does not account for any likely increase in usage after the FDA’s 2021 decision to expand access to the pill by mail, nor from the likely increase in pills being acquired from the internet – including from overseas – since Roe v Wade was overturned.
Prior to 2017, the incidence of medication abortion was far lower: around 39% of all US abortions in 2017, according to the Guttmacher Institute, 31% in 2014; 23% in 2011, 17% in 2008, 6% in 2005 and 6% in 2001.
With abortion banned in more than a dozen states since Roe v Wade fell, the number of legal abortions in the US has been reported to have fallen by 6%. However, the increase in people ordering pills online may be significantly mitigating that drop.
It may be this impact, in offsetting the effect of abortion bans, that is fueling the rightwing push against the pills.
