Is mifepristone legal? Is it safe? What’s going on in the courts?
It’s been a confusing, consequential few days for the future of abortion access in America.
Matthew Kacsmaryk, a federal judge in Texas, issued an April 7 decision suspending the FDA’s approval of mifepristone, one of two drugs used to conduct medication abortion — a procedure that makes up the majority of abortions in the US.
Although mifepristone has been used for more than 20 years in the US with few severe side effects, the judge agreed with the argument put forth by the plaintiff, the anti-abortion group Alliance for Hippocratic Medicine, which claimed that the FDA had bowed to political pressure from the Clinton administration in approving the medication and did not adequately evaluate safety concerns. Former FDA commissioner Jane Henney defended her agency’s approval to NPR this week, saying, “Mifepristone was handled in a very proper way. It was given a very thorough review. It was not rushed.”
Also on Friday, a judge in Washington state issued a contradictory order, saying that the FDA could not impose any more restrictions on access to the drug.
Kacsmaryk’s ruling provided a seven-day waiting period for the case to be appealed. But the situation has raised big questions about mifepristone and medication abortion. 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. The FDA recommends the drug be taken within the first 10 weeks of a pregnancy, though the World Health Organization recommends it up to 12 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?
Kacsmaryk’s decision has not gone into effect yet, meaning nothing has changed since before the decision was issued. Doctors in states without total abortion bans can still prescribe mifepristone for abortions, and patients can still get it at clinics, by mail, or at a pharmacy (if their pharmacy has been certified to dispense it).
If the FDA is ultimately forced to rescind its approval of mifepristone, it will have to decide how to enforce that decision, which will determine how health care providers respond and where and how patients can get the medication.
But, regardless of what happens, the medication will not become a controlled substance like heroin or other illegal drugs. Instead, for people who are still able to get mifepristone (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, South Carolina and Nevada, actually have laws against self-managed abortion, procedures patients complete outside the 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 or assault laws or other statutes, often 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 short answer is that it is really messy. Currently, there are two conflicting orders, handed down by two different federal courts, which require the FDA to behave in mutually contradictory ways.
The first of the two is Judge Matthew Kacsmaryk’s decision in Alliance for Hippocratic Medicine v. FDA, which halts the FDA’s 23-year-old decision to allow mifepristone to be marketed in the United States. Kacsmaryk’s order is not currently in effect, but it will take effect on April 14 unless a higher court intervenes.
The second order is from Judge Thomas Rice in a case called Washington v. FDA, and prohibits the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone,” at least in the 17 states plus the District of Columbia which filed this lawsuit. It is not possible for the FDA to simultaneously maintain the status quo, as Rice’s order requires, and to effectively bar mifepristone from the marketplace, as Kacsmaryk’s order will require if it takes effect.
Neither of these orders are paragons of legal reasoning. Kacsmaryk’s order is a trainwreck riddled with so many legal errors that it raises serious questions about whether Kacsmaryk, a longtime Christian right operative, even attempted to comply with the law when he wrote his opinion. Rice’s decision, meanwhile, is less of a disaster than Kacsmaryk’s. But it is unclear why he had the authority to issue an injunction requiring the FDA to keep doing what it is already doing.
In any event, there is a decent chance that a higher court will intervene before Friday — thus rescuing the FDA from the impossible task of trying to comply with these two mutually contradictory orders.
The Justice Department has asked the Washington judge to clarify his order. But more importantly, the US Court of Appeals for the Fifth Circuit is right now considering the Justice Department’s request to temporarily block Kacsmaryk’s order while this case is fully litigated on appeal. The DOJ asked the Fifth Circuit to rule on this request by noon on Thursday. And the court, which required both parties to brief this case on a highly expedited schedule, appears likely to honor that request.
That said, the Fifth Circuit is probably the most right-wing appeals court in the entire federal system. So it is more likely than not that the Fifth Circuit will deny the DOJ’s request; if that happens, the agency will almost certainly seek an emergency order from the Supreme Court halting Kacsmaryk’s order before it goes into effect.
Though the Supreme Court is very conservative, it claimed in Dobbs v. Jackson Women’s Health Organization (2022), the decision overruling Roe v. Wade, that “it is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.” Similarly, Justice Brett Kavanaugh wrote in a separate concurring opinion that his Court “must scrupulously adhere to the Constitution’s neutral position on the issue of abortion.”
So the Supreme Court has at least claimed that it will not allow federal judges like Kacsmaryk to impose their anti-abortion views on the nation.
The current fight in the Fifth Circuit (and the possible coming fight in the Supreme Court) concerns only whether Kacsmaryk’s order will be temporarily blocked while this case is being appealed. There will be another round of appeals to determine whether Kacsmaryk’s decision should be permanently reversed. Those appeals will also be heard first by the Fifth Circuit, and then potentially by the Supreme Court.
So, while there’s a real chance that a higher court will temporarily halt Kacsmaryk’s attempt to ban mifepristone as soon as Wednesday afternoon, the case may not be permanently resolved for months or more. —Ian Millhiser
5) How do people get mifepristone now?
Until and unless Kacsmaryk’s ruling actually goes into effect, access to mifepristone is unchanged — people can still get mifepristone in states that allow medication abortion. If the ruling does go into effect, patients may not be able to get the medication at a clinic or pharmacy, or from telehealth providers.
However, they will still have options for obtaining the drug. They can order 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, as Vox’s Rachel Cohen reported. In addition, at least two states, Massachusetts and Washington, have stockpiled doses of the medication in case it becomes unavailable nationwide. These states are also developing legal workarounds to allow health care providers to stock and dispense the drug if Kacsmaryk’s ruling goes into effect.
Though nothing is certain in the current legal climate, providers in states that are stockpiling mifepristone would probably be at low legal risk if they continue to prescribe it, said Rosann Mariappuram, senior policy counsel for reproductive rights at State Innovation Exchange, a group that works with state lawmakers on progressive policies. Authorities in those states, she said, are signaling that they are friendly to mifepristone and unlikely to cooperate with efforts to remove it from the market. —Anna North
6) 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, said Mariappuram. 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.
Kacsmaryk’s ruling has not gone into effect yet. If it does, the FDA has 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,” Mariappuram said. The FDA could also be more aggressive, by working with local law enforcement to seize the medication, or by filing suit to keep an individual or group from prescribing it. However, several progressive-leaning states, including New York and Washington, have already signaled that they want to safeguard medication abortion access, and may be unlikely to work with federal regulators to seize mifepristone or otherwise penalize providers who offer it.
Some lawmakers, including Reps. Alexandria Ocasio-Cortez (D-NY) and Nancy Mace (R-SC) and Sen. Ron Wyden (D-OR), have said that the FDA should simply ignore Kacsmaryk’s ruling. That will likely be difficult, Mariappuram said, since the conflicting ruling by Rice in Washington state requires the FDA to maintain approval of mifepristone. Moreover, legal experts have cautioned that just ignoring Kacsmaryk’s ruling wouldn’t really protect access to the drug, since doctors might be afraid to prescribe it in such an uncertain legal landscape, and a future Republican administration could always decide to abide by Kacsmaryk’s ruling and act aggressively to get mifepristone off the market.
With two competing rulings, too, Mariappuram said, the FDA will probably have to do something — and what it does will probably depend on how or if the rulings hold up in court. Even if Kacsmaryk’s ruling prevails, one legal scholar told Politico that the FDA could “re-initiate the approval process of mifepristone all over again to get it back on the market.” However, it’s unclear if that option is on the table at this point. —Anna North
7) 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 already existing staffing challenges clinics have been managing since Roe’s overturn.
Another option would be 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 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. —Rachel Cohen