A decision in a highly anticipated federal court case was issued today: A district judge in Texas suspended the federal approval of mifepristone, a US Food and Drug Administration-approved drug used to induce abortions.
But the decision will not go into effect for seven days to allow the federal government time to appeal the decision or seek emergency relief, meaning that for now, the medication will remain available.
Judge Matthew Kacsmaryk of the Northern District of Texas issued a ruling revoking the FDA’s approval of the drug. If the ruling goes into effect after the seven-day window passes, it would mean that US health care providers, which are subject to FDA rules and regulations, could no longer prescribe mifepristone — even in blue states where abortion is not otherwise restricted.
The case will almost certainly be appealed, and one possibility is that the appellate court or the Supreme Court issues a stay while the lawsuit continues, meaning mifepristone could continue to be prescribed in the states where it is currently legal.
A federal judge in Washington State issued a directly contradictory ruling on Friday evening, moments after Kacsmaryk’s, prohibiting the FDA from pulling mifepristone from the market.
The availability of the drug will ultimately be decided by higher courts. But if mifepristone were to be pulled off the market, the consequences for access to abortion would be severe. Medication abortion — referring to the combination of both mifepristone and misoprostol — accounts for more than half of all abortions in the US, and is used typically within the first 10 to 12 weeks of a pregnancy. It’s 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.
The anti-abortion movement has been trying to restrict access to medication abortion since before the overturn of Roe, but those tactics were focused primarily on curbing access state-by-state, not through sweeping national action. The Texas lawsuit represents the increasing aggressiveness of the anti-abortion movement to take aim not only at abortion access in conservative states controlled by Republicans, but also deep blue states run by Democrats.
What is mifepristone?
Mifepristone is a prescription drug that works by blocking 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.
For medication abortions, a second drug — misoprostol — is then used. Misoprostol has been around since the 1970s, and was first developed to treat stomach ulcers. An individual seeking to end a pregnancy would take misoprostol 24 to 48 hours after mifepristone, causing their cervix to soften, prompt contractions, and expel the embryo.
Mifepristone is also used for other situations like miscarriage management, and helping patients with Cushing’s syndrome who also have Type 2 diabetes. Lawyers for the plaintiffs insist restricting mifepristone for abortion won’t impact patients who use the drug for other reasons, but already some pharmacists and doctors have resisted prescribing misoprostol to patients, wary of breaking new laws or suspicious patients will use the drugs covertly for an abortion. Walgreens recently confirmed it would not dispense mifepristone even in states where the drug remains legal, following threats from anti-abortion groups and Republican attorneys general.
The drug was authorized by the FDA in 2000 and is approved for ending a pregnancy in the US up to 10 weeks’ gestation, though the World Health Organization recommends mifepristone up to 12 weeks.
Between 2000 and 2018, more than 3.7 million women in the United States used the medication — sold under the brand Mifeprex — to end an early pregnancy. In 2016 the FDA reported mifepristone’s “efficacy and safety have become well-established by both research and experience, and serious complications have proven to be extremely rare.” Three years later the agency approved a generic version, GenBioPro.
Why is there a lawsuit attacking mifepristone?
Back in November, a lawsuit challenging the legality of mifepristone was filed on behalf of a coalition of anti-abortion groups and doctors known as the Alliance for Hippocratic Medicine. Led by the conservative legal advocacy group Alliance Defending Freedom, the lawsuit claims the FDA caved to political pressure under Bill Clinton when it approved mifepristone more than 22 years ago, and it should thus be pulled from the market.
The lawsuit claims the FDA didn’t properly assess mifepristone’s safety, and that the federal government has put people at risk more recently by making the medication easier to obtain. Examples it cites include the FDA extending in 2016 the recommended window of time to take mifepristone from seven weeks of a pregnancy up to 10, and removing a requirement in 2021 that women must pick up mifepristone in-person, thereby making telehealth and mail-orders more accessible.
The National Academies of Sciences, Engineering, and Medicine has affirmed medication abortion as a safe method to terminate pregnancy, and concluded that there is no medical need for the drugs to be administered in the physical presence of a health care provider. The FDA has also repeatedly rejected the evidence the plaintiffs claim shows medication abortion is unsafe.
The case has virtually no scientific merit, and challenging the use of a drug that has been studied and safely used for over two decades is highly unusual. Most Americans also believe medication abortion should be accessible. A new poll released in early March found majorities of Americans — including majorities of Democrats and independents — support keeping medication abortion legal and allowing women to use it at home to end an early-stage pregnancy. Another recent survey found 59 percent of voters disapprove of overturning the FDA’s approval of abortion medication, including 72 percent of Democrats, 65 percent of Independents, and 40 percent of Republicans.
But legal experts concede these are legally unpredictable times given the politicization of the courts. The federal lawsuit was intentionally filed in Amarillo, Texas, so that Kacsmaryk, a conservative judge, would hear the case. Kacsmaryk was appointed by Donald Trump and is a former Christian activist who has denounced the sexual revolution of the 1960s and ’70s.
Last year he ruled that federal law prohibiting certain forms of discrimination by health providers does not protect against anti-LGBTQ discrimination, and in a separate case, he concluded that teenagers can’t access birth control without their parents’ permission under Title X, a federal program that provides family planning and preventative health services. Kacsmaryk claimed allowing teenagers to decide for themselves about birth control would “violat[e] the constitutional right of parents to direct the upbringing of their children.”
What are the implications of the decision?
This was a lower-court decision, so this legal battle is not over — and the judge’s decision gives the federal government seven days to seek emergency relief. The federal government will either appeal to the United States Court of Appeals for the Fifth Circuit, or directly to the US Supreme Court.
One possibility is that the appellate court or the Supreme Court issues a “stay” as the case continues to be litigated, meaning mifepristone could continue to be prescribed, even once the seven-day window has passed, while the lawsuit goes on. When Roe was on the books there were lots of court-ordered abortion bans upheld in district courts like Kacsmaryk’s, but then never enforced because pro-choice attorneys would successfully win “stays” as they proceeded to appeal the bans in higher-level courts. Whether an appellate court in a post-Roe environment would be as willing to block a lower judge’s order while the case continues is an open question.
David Cohen, a law professor at Drexel University who specializes in reproductive rights law, said before Kacsmaryk issued his order that typically an appellate court would consider whether a lower court order would be so disruptive to the status quo that it needs to be put on hold while they consider the case. In normal times, abruptly taking an FDA-approved drug off market that’s been safely used by millions of women for over 20 years would certainly meet the threshold of “very disruptive” to the status quo.
“But I think we are in a world where the conservative Fifth Circuit feels very emboldened so we can’t count on [a stay],” Cohen told Vox. Another option is the FDA appeals directly to the Supreme Court, skipping the Fifth Circuit. “We’ve seen more litigants doing that in recent years, though usually it’s been conservative litigants,” Cohen explained. “I don’t know if the FDA would want to do that, but it’s possible they think they’d get a fairer shake at the Supreme Court.”
What options for abortion are still available right now?
For the next seven days, nothing will change, according to Kacsmaryk’s order.
Even if the drug is ultimately pulled from the market, people seeking abortions could still access care at in-person clinics for the surgical abortion procedure. But those abortions typically cost more money, and require more time and resources from the already-strapped clinics. In its legal filing opposing the lawsuit, the US Justice Department warned that taking mifepristone off the market would lead to delays and overcrowding at these in-person clinics, which were already managing an influx of out-of-state patients since Roe was overturned.
Another option that would remain even if the order takes effect is ordering pills from the European-based nonprofit, Aid Access, which bypasses US restrictions by prescribing the drugs to patients from overseas. This European organization services people in all 50 states, but because the medication ships internationally, it can often take two to three weeks for pills to arrive.
A third option would be pursuing medication abortion using only misoprostol. This method is not FDA-approved, but it is backed by the World Health Organization, and a common way of ending pregnancies around the world. Last month the first study to examine misoprostol-only abortions in the US was published and researchers found the drug to be 88 percent effective, with few incidents of serious adverse events or signs of a potential abortion complication. In comparison, research in the US on using mifepristone and misoprostol together have shown success rates of 95 percent. But research on misoprostol-only abortions in other countries have also shown similar efficacious results, ranging between 95 and 99 percent.
Abortion providers, though they express adamant opposition to the Texas lawsuit, have also been preparing to offer misoprostol-only abortions if mifepristone is taken off market. The National Abortion Federation, in its clinical guidelines, say 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.
There are also pending federal lawsuits to expand access to medication abortion
In addition to battling this lawsuit from anti-abortion groups, reproductive health organizations have been planning their own legal strategies to expand access to abortion pills. In January, two such lawsuits were filed, claiming two states’ restrictions on mifepristone illegally preempt the FDA.
Through the passage of the Federal Food, Drug, and Cosmetic Act in 1938, Congress empowered the FDA as the sole agency to approve drugs in the US. It’s responsible for reviewing a drug’s safety, weighing its risks and benefits, and regulating appropriate conditions for safe and effective use.
With this in mind, GenBioPro, the generic manufacturer of mifepristone, argued in a new lawsuit that West Virginia’s state abortion ban is unconstitutional because it violates the supremacy and commerce clauses of the US Constitution, which empowers the FDA as the sole regulator of drugs across the country.
A similar case, filed in January by an obstetrician-gynecologist in North Carolina, challenged state officials for imposing restrictions on mifepristone that go beyond what the FDA requires. North Carolina requires doctors to provide mifepristone in-person at a particular type of facility after a 72-hour waiting period and, in some cases, an ultrasound.
Experts say there is a “strong, though legally uncertain” argument that the Supremacy Clause of the US Constitution gives the federal government authority over these conflicting state rules. This idea — that federal regulation of drugs would take precedence, and a state cannot ban a drug that has been given federal approval — is known as the preemption argument.
For now, legal scholars say it’s unclear how preemption arguments will play out in court. Courts often grant deference to the FDA, though there are relatively few examples involving drugs. The main precedent is a 2014 case where a federal judge struck down a Massachusetts effort to restrict the opioid Zohydro, since the FDA had approved the painkiller. If the plaintiffs win their case, millions more people could have easier access to mifepristone.