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Editor’s note, April 19: This story was originally published on April 12 and last updated on April 13. On April 19, the Supreme Court extended its stay of federal Judge Matthew Kacsmaryk’s order, meaning mifepristone remains legal and fully available for now. Read Vox’s latest coverage of mifepristone and related court cases here.
It’s been a confusing, consequential few days for the future of abortion access in America.
On April 7, Matthew Kacsmaryk, a federal judge in Texas, issued a decision suspending the Food and Drug Administration’s approval of mifepristone, one of two drugs used to administer medication abortion, a procedure that makes up the majority of abortions in the US. The same day, a federal judge in Washington state issued a conflicting opinion, barring the FDA from putting more restrictions on mifepristone.
The Biden administration challenged the Texas decision in the Fifth Circuit Court of Appeals, and on April 12, that court issued its own decision. In a temporary ruling that could potentially be displaced by the Supreme Court, the Fifth Circuit rejected parts of Kacsmaryk’s ruling — namely the part about suspending mifepristone entirely from the market — but upheld other restrictions, which could severely restrict access to the medication.
The case in the appellate court is not over, and will continue to be litigated, eventually before a different Fifth Circuit panel and then potentially before the Supreme Court.
For now mifepristone remains available — but the situation is changing quickly, and providers are working in real time to figure out what to make of the evolving, and in some cases conflicting, orders. These challenges have raised big questions about mifepristone specifically and medication abortion generally. Here are some of those questions and their answers.
1) What is mifepristone?
Mifepristone is one of two drugs used to perform an abortion. It blocks the hormone progesterone, which maintains the interior of the uterus. If progesterone is blocked, the uterus can’t support a pregnancy and the embryo is detached. Since 2016, the FDA has recommended the drug be taken within the first 10 weeks of a pregnancy, though the World Health Organization recommends it up to 12 weeks. (The Fifth Circuit decision reduced that timeline to the FDA’s previous recommendation of seven weeks.)
Medication abortion — the combination of mifepristone and a second drug, misoprostol — has become the most common method for ending pregnancies in the United States, partly due to its safety record, its lower cost, diminished access to in-person care, and greater opportunities for privacy.
Mifepristone has been used by over 5 million women in the United States since it was first authorized by the FDA 23 years ago. In 2016, the FDA reported that mifepristone’s “efficacy and safety have become well-established by both research and experience, and serious complications have proven to be extremely rare.”
Mifepristone is also used for other situations like miscarriage management and helping patients with Cushing’s syndrome who also have Type 2 diabetes. —Rachel Cohen
2) Is mifepristone still legal?
Doctors in states without total abortion bans can still prescribe mifepristone for abortions, but the Fifth Circuit decision called for reimposing some restrictions that had been lifted in 2016. It’s not clear at this time what will come of this, since the case is still being appealed. Nor is it clear how the FDA might use its enforcement discretion. The Fifth Circuit, for its part, has called for the drug to be prescribed only in the first seven weeks of pregnancy, for multiple in-person visits with a doctor, and for the pills to no longer be sent through the mail.
Regardless of what happens in the courts, mifepristone will not become a controlled substance like heroin or other illegal drugs. Instead, for people who are still able to get the medication (more on that below), possessing it will be legally the same as having most other drugs without a prescription — a misdemeanor, not a felony, in most states. Having mifepristone would be akin to having Viagra or a statin drug without a prescription, said Farah Diaz-Tello, senior counsel and policy director at the reproductive justice legal group If/When/How.
Reproductive justice advocates aren’t especially worried about people being prosecuted for possessing mifepristone without a prescription, but are concerned about people being criminalized for taking mifepristone to end a pregnancy if Kacsmaryk’s ruling goes into effect.
Currently, taking the drug is not explicitly illegal in most states. Only two states, South Carolina and Nevada, actually have laws against self-managed abortion, which are self-induced abortions undertaken outside the formal medical system using pills obtained online or through friends or acquaintances.
In other states, prosecutors have attempted to charge people for ending their own pregnancies under homicide laws and other statutes, including after they sought medical treatment. Prosecutors may become more zealous in prosecuting people for taking abortion medication in the wake of Kacsmaryk’s ruling, Diaz-Tello said, but only because it will increase attention to and scrutiny of medication abortions — the actual laws around self-managed abortion have not changed.
These legal nuances are likely to be confusing to the average American who is, as Diaz-Tello put it, “just living their life and trying to figure out a way to exercise some control over their reproductive future.”
If/When/How maintains a legal helpline where people can get free, confidential advice about self-managed abortion. “I really want people to know that they’re not alone in trying to have to parse this,” Diaz-Tello said. —Anna North
3) Is mifepristone safe?
Many FDA-approved drugs come with some safety risks. But the high level of scrutiny means that over the last 23 years, we’ve learned a lot about mifepristone — and it’s shown that medication abortion is very, very safe. Rates of patient deaths due to mifepristone are lower for mifepristone than they are for Tylenol, penicillin, or Viagra.
A 2013 report reviewed results from 87 studies, which included data from more than 45,000 people who’d had medication abortions worldwide. It found the drug combination effectively ended pregnancy in 95 percent of patients. It also showed that serious side effects — symptoms so severe they required hospitalization — were very rare. The most common ones were vaginal bleeding, pelvic pain, and infection. Symptoms this serious occurred in only 3 out of every 1,000 patients, and only 1 out of 1,000 needed a blood transfusion.
For Americans, taking mifepristone is far safer than pregnancy: A 2012 study found the death rate associated with childbirth was 14 times that associated with abortion. —Keren Landman
4) What’s going on in the courts?
The latest development in the case was the Fifth Circuit ruling. For now, mifepristone remains legal, though the Fifth Circuit attempts to impose some restrictions on its use.
The plaintiffs in the original lawsuit, filed in Kacsmaryk’s district, challenged not only the FDA’s approval of mifepristone but also the agency’s previous decisions in 2016, 2019, 2021, and 2023 to make it easier for abortion providers to prescribe the drug. Among other things, these FDA actions allowed mifepristone to be prescribed up to the 10th week of pregnancy, reduced the number of in-person visits for patients seeking mifepristone from three to one, and allowed some non-physician health providers to prescribe the medication.
The Fifth Circuit’s decision effectively invalidates all of these changes, thus attempting to reset the rules governing mifepristone to where they were before 2016.
Realistically, this Fifth Circuit decision is unlikely to matter in the short or long run. The Justice Department has already announced it will immediately try to bring this case to the Supreme Court, seeking an order that overturns the Fifth Circuit’s restrictions on the FDA.
One additional wrinkle is the Washington judge’s ruling in the separate case, called Washington v. FDA, which forbade the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone.” That decision obviously conflicted with Kacsmaryk’s original order to ban mifepristone, and it still also conflicts with the Fifth Circuit’s decision to dismantle many of the FDA’s changes to how and when mifepristone may be dispensed.
These conflicting court orders will most likely force the Supreme Court to rule on this case, and soon. The alternative is that the FDA must violate at least one court order.
And barring a Supreme Court ruling on the underlying issues, the Justice Department’s full appeal of Kacsmaryk’s ban will eventually be heard by a different Fifth Circuit panel, and potentially by the Supreme Court. —Ian Millhiser
5) What does it mean to revoke FDA approval?
Getting Food and Drug Administration approval for a drug is an arduous process, and if it’s ever revoked, it’s usually because an investigation has revealed safety concerns. But that’s not what happened in this case; instead, if the drug’s approval is revoked, it would be because of a court ruling. That, according to legal experts, is unprecedented.
If the approval is ultimately revoked, the FDA would have several options for how to respond.
The agency could simply send warning letters to providers who are prescribing mifepristone stating that the medication is no longer approved. “They don’t have to go further than that,” said Rosann Mariappuram, senior policy counsel for reproductive rights at State Innovation Exchange, a group that works with state lawmakers on progressive policies, said. The FDA could also be more aggressive, by working with local law enforcement to seize the medication, or by filing suit to keep doctors from prescribing it. However, whether Democratic-led states would cooperate with federal regulators to seize mifepristone or otherwise penalize providers who offer it is unclear.
If approval is revoked, the FDA can also initiate a new process to approve the drug again, and some legal advocates are encouraging that route. —AN
6) If mifepristone is taken off the market, what happens to people seeking abortions?
In states where in-person abortion clinics exist, people can still access surgical abortions. But those procedures typically cost more and wait times for an appointment will likely be longer, given the existing staffing challenges that clinics have been managing since Roe’s overturn.
It’s unclear what will happen to another option: ordering pills either from the European-based nonprofit Aid Access, which bypasses US restrictions by prescribing the drugs to patients from overseas, or through alternative methods vetted by the reproductive justice group Plan C such as mail forwarding. “We will not let this unjust ruling stop people from accessing abortion pills, which are readily available through alternate supply routes in the US,” Plan C co-director Elisa Wells said after the Texas district court ruling came down.
It’s also possible to pursue medication abortion using only misoprostol. While not FDA-approved, this method is backed by the World Health Organization, and is a common way of ending pregnancies around the world. In February, researchers found misoprostol-only abortions in the US to be 88 percent effective, with few incidents of serious adverse events or signs of a potential abortion complication.
Some abortion providers have been preparing to offer misoprostol-only abortions if mifepristone is taken off market, though many say it will take them time to transition. The National Abortion Federation, in its clinical guidelines, says that “where mifepristone is either not legally available or inaccessible, misoprostol-alone regimens may be offered.” Because misoprostol has been FDA-approved to treat stomach ulcers and can be prescribed off-label for solo use, there is less concern that access to that drug will disappear. —RC
Update, April 13, 3:15 pm ET: This story was originally published on April 12 and has been updated to reflect the Fifth Circuit Court’s decision and subsequent developments.
