A decision in a highly anticipated federal court case was issued Friday night: A district judge in Texas, with longstanding and outspoken anti-abortion views, suspended the US Food and Drug Administration’s approval of mifepristone, a widely used drug to end pregnancies.
But the judge, Matthew Kacsmaryk of the Northern District of Texas, ordered that his decision would not take effect for seven days to allow the federal government time to appeal his decision. Within hours, both the US Justice Department and Danco Laboratories, a manufacturer of mifepristone, announced their plans to challenge the ruling.
For now, access to the drug remains unchanged.
Adding to the chaos and uncertainty, a second and competing federal court decision regarding mifepristone was released Friday in Washington state, in a case led by 17 Democratic attorneys general who argued the FDA had actually been too restrictive when it approved mifepristone.
The federal judge in that case, Thomas Rice, issued a preliminary injunction blocking the FDA from taking “any action to remove mifepristone from the market or otherwise cause the drug to become less available.”
While Rice’s decision applies only to the 17 states involved in the lawsuit, his order would conflict with the nationwide injunction Kacsmaryk just issued, which could set up an accelerated path for the US Supreme Court to take up the issue. The Biden administration said it is still reviewing the Washington state decision.
Kacsmaryk’s decision was riddled with false statements about medication abortion and the risks of mifepristone, which has been used by millions of women since it was first approved by the FDA 23 years ago. It’s unprecedented for a district judge to reverse the FDA’s approval of a drug, and some reproductive rights groups warn this could set the stage for similar challenges to other drugs anti-abortion groups oppose, like birth control and emergency contraception.
On Friday night, President Biden vowed to fight the Texas decision, emphasizing that if it were to stand, “there would be virtually no prescription approved by the FDA safe from this kind of attack.”
Sen. Ron Wyden (D-OR), who chairs the Senate Finance Committee that oversees the FDA, said in a statement that he believes the FDA has the authority to ignore Kacsmaryk’s ruling. “The FDA, doctors, and pharmacies can and must go about their jobs like nothing has changed and keep mifepristone accessible to women across America,” he said.
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 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 past attempts to challenge the FDA’s approval process were all summarily rejected. The Texas lawsuit and the plaintiffs’ demand for a nationwide injunction represent the increasing aggressiveness of the anti-abortion movement to take aim at abortion access not only in conservative states controlled by Republicans, but also in 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 and their uterus to contract 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.
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 that 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. Jack Resneck Jr., the president of the American Medical Association, said in a statement Friday night that Kacsmaryk’s “disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation.”
Most Americans also believe medication abortion should be accessible. A poll released in early March found majorities of Americans 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 openly opposed abortion for decades.
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.
What are the implications of the decisions?
Both decisions in Texas and Washington state were issued by lower courts, so these legal battles are not over. The federal government has already said it will appeal the Texas decision, but it’s unclear if the Biden administration will appeal to the Fifth Circuit, or go directly to the US Supreme Court.
Will mifepristone remain available? One possibility is that the Fifth Circuit or the Supreme Court issues a “stay” as the case continues to be litigated, meaning the drug could continue to be prescribed, while the lawsuit stretches 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 lawyers would successfully win “stays” as they proceeded to challenge the bans in higher-level courts. Whether appellate courts in the post-Roe era 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 district court order would be so disruptive to the status quo that it needs to be halted while they consider the case. In normal times, abruptly taking off the market an FDA-approved drug that has 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. It’s possible, especially given the Washington state decision, that the Biden administration skips the Fifth Circuit and appeals directly to the Supreme Court. “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 at least the next week, nothing will change,
If mifepristone is ultimately pulled from the market, people seeking abortions could still access care at in-person clinics for surgical abortions. But those procedures typically cost more money, and require more time and resources from already-strapped abortion clinics. In its legal filing opposing the Texas case, the Justice Department warned that taking mifepristone off the market would lead to delays and overcrowding at these clinics, which were already managing an influx of out-of-state patients since Roe’s overturn.
Another option that would remain even if the order takes effect is 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 Friday night.
Another option would be pursuing medication abortion using only misoprostol. While not FDA-approved, this method is backed by the World Health Organization, and 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. In comparison, research in the US on using mifepristone and misoprostol together has shown success rates of 95 percent. But research on misoprostol-only abortions in other countries has also shown similar efficacious results, ranging between 95 and 99 percent.
Abortion providers, though they expressed adamant opposition to the Texas lawsuit, have been preparing to offer misoprostol-only abortions if mifepristone is taken off market. 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.
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 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.
In response to Kacsmaryk’s ruling, GenBioPro issued a statement affirming that as it reviews the Texas decision, it will continue to make its product available. “The bottom line is, we are confident in the legality of mifepristone’s approval,” CEO Evan Masingill said.
A similar case, filed in January by an OB-GYN 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 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.