The federal judiciary is currently engulfed in a battle over the fate of mifepristone, the first of two drugs used in a medication abortion. Although the Food and Drug Administration approved the medication in 2000, and more than 100 scientific studies have demonstrated that it is extremely safe and effective, it has become a major target since Roe v. Wade was overturned last June. Most recently, two lower courts have attempted to overrule the agency’s scientific judgments, which would make mifepristone illegal across the country. A different court, however, has issued a competing injunction protecting access to mifepristone in most states where it remains legal. The Supreme Court will wade into this fight within the next few days. As we wait, we decided to do our best to answer some of the most common questions about this increasingly confusing litigation.
Why is the availability of mifepristone suddenly in question?
Because anti-abortion activists, led by Alliance Defending Freedom—a far-right, anti-LGBTQ, anti-abortion law firm—saw the post-Roe landscape as a good opportunity to bring a lawsuit against the medication. The lawsuit has no basis: They claimed the FDA’s approval of mifepristone in 2000 was illegal mostly by relying on literal anti-abortion propaganda to claim that mifepristone is dangerous (it is not). They asked U.S. District Judge Matthew Kacsmaryk, a lifelong foe of reproductive rights, to pull it off the market. Kacsmaryk sided with the plaintiffs and purported to “suspend” the 23-year-old approval of the drug, which is not really something that’s in his purview to do—the FDA must follow rules set by Congress, not the courts (more on that in a moment).
On appeal, the 5th U.S. Circuit Court of Appeals pulled back from Kacsmaryk’s extreme stance, but attempted to reimpose a slew of restrictions on mifepristone that haven’t been enforced since 2016. These include three mandatory in-person doctor’s visits for anyone taking the drug; a ban on the cheaper, generic version of the drug; and approval through only seven weeks of pregnancy instead of ten (though doctors could still prescribe it off-label beyond seven weeks).
And so now the Supreme Court is involved?
Both the Justice Department and Danco Laboratories, which manufactures mifepristone, asked SCOTUS to freeze the 5th Circuit’s decision and preserve the status quo. If the justices do this, nothing will change; access to mifepristone will remain the same. If the justices don’t do this, all those gratuitous roadblocks to mifepristone might snap back into place.
So what will the Supreme Court do?
On Friday, Justice Samuel Alito granted a brief administrative stay on the case, lasting until Wednesday at midnight, which means none of these new rules will take effect yet. But it also doesn’t tell us anything about which way the court is leaning.
The full court will almost certainly take action by Wednesday night. Broadly speaking, it has two options: Halt the 5th Circuit’s court order or let it take effect. It seems more likely that SCOTUS will halt the order, for two reasons: First, it brazenly flouted a series of fundamental legal principles; and second, it conflicts with a different order from a federal judge in Washington State. (More on that soon.) But it’s impossible to know how far this Supreme Court will go to curb reproductive rights, which is a huge part of the problem—ever since Dobbs, precedent has gone out the window.
And what’s this about a Washington State case?
That’s the wild card. Anticipating Kacsmaryk’s decision—which would have removed mifepristone from the market even in states where abortion is protected and remains legal—17 blue states and D.C. asked a liberal judge, Thomas O. Rice, to protect the drug’s legality within their borders. Twenty minutes after Kacsmaryk ruled, Rice issued a dueling injunction that maintained access to mifepristone in those blue jurisdictions. He later clarified that his ruling bound the FDA “irrespective of” decisions from Kacsmaryk or the 5th Circuit—creating a direct conflict between the two orders. Rice’s order hasn’t reached the Supreme Court yet, but if the justices want to spare the FDA from having to choose between two mutually exclusive injunctions, they’ll have to stay the 5th Circuit decision.
Does that mean we’re in a … constitutional crisis?
Actually, yes. Different courts are effectively forcing the FDA to break the law by choosing which injunction to follow. That situation is not tenable. Executive branch officials are similarly on the brink of being compelled to violate a court order. Moreover, the internal power struggle within the judiciary indicates that constitutional safeguards to guarantee the orderly administration of law are breaking down. This crisis is probably the inevitable result of the judiciary’s unceasing seizure of power from the democratic branches.
Let’s say the Supreme Court eventually upholds the 5th Circuit decision and lifts Rice’s injunctions. Would that really cut off access to mifepristone in blue states?
It could. Part of the problem here is that the 5th Circuit does not understand how FDA regulations work. The 5th Circuit made it sound like courts could simply resuscitate old barriers to access, but the process is far more complicated than that. To comply with these restrictions, mifepristone’s manufacturer would have to revise its labels, recertify providers, and submit a supplemental drug application for approval—all of which could take months. In the meantime, mifepristone might theoretically remain unapproved.
Do courts really have the power to impose new limits on a drug?
No—courts have no authority to override the complex regulatory process that Congress required for the imposition of new restrictions on an FDA-approved medication. Nor do they have the practical ability to enforce these restrictions in the real world. The FDA has vast enforcement discretion over the regulation of drugs. If the Supreme Court refuses to freeze the 5th Circuit’s decision, the agency can announce that it will not force medical providers to adhere to the new restrictions. In doing so, it will assure blue-state providers that they can continue prescribing mifepristone without fear of sanctions. The alternative is to let courts overrule the FDA’s expert scientific determinations, creating a precedent that would make it impossible to bring new drugs to market.
I heard the 5th Circuit also tried to smuggle in a nationwide ban on abortion by reviving the Comstock Act. Is that true? Also, what is the Comstock Act?
It is true!The Comstock Act is an archaic, unenforced law passed in 1873 to let the federal government censor the mail to protect Victorian-era views of Christian morality. One provision bars the mailing of drugs for the purpose of “causing unlawful abortion.” The plaintiffs in this case have exploited internal contradictions in the statute to claim that it prohibits the mailing of drugs that cause any abortion, whether lawful or not.
Although federal courts uniformly rejected that interpretation in the early 1900s, Kacsmaryk and the 5th Circuit found it persuasive. If the Supreme Court agrees, providers will no longer be able to mail abortion pills to patients. The long-term implications are even more dire: The Comstock Act’s overbroad language could effectively outlaw medication abortion by making it illegal to transport to clinics, pharmacies, or patients. President Joe Biden presumably won’t enforce this ban, but the next Republican president probably would—threatening violators with years of incarceration.
This seems really scary?
Yes, it is a wild and unprecedented situation, honestly, that matters for access to this specific medication, and additionally matters for broader “rule of law”/“how the country functions” reasons.
Yikes. Let’s turn back to the immediate stakes of this case. Say the Supreme Court lets the 5th Circuit ruling take effect, and the FDA doesn’t fight it. What happens next? Is medication abortion effectively prohibited in all 50 states and the District of Columbia?
No, and that’s one major irony of this case. While the two-drug regimen of mifepristone and misoprostol remains the most effective method, patients can also terminate a pregnancy using misoprostol alone. “Misoprostol-only” abortions may have somewhat more unpleasant side effects, but they are used around the world to safely end a first-trimester pregnancy. Misoprostol is far easier to access than mifepristone because it treats many conditions that have nothing to do with abortion, including stomach ulcers. In the long run, misoprostol-only abortions could still run into problems with the Comstock Act. But for now, if U.S. providers can no longer prescribe mifepristone—or can only do so by jumping through impossible hoops—they will turn to a misoprostol-only regimen.
Wait: The plaintiffs say they want to abolish medication abortion supposedly to protect women, but if they succeed, they’ll actually just make medication abortion slightly riskier and more painful for women. Do they realize that?
The plaintiffs acknowledged this fact in court. That, alone, should end the case, because—stay with me— when plaintiffs ask for a remedy that does not cure their alleged injury, they lack standing to sue in the first place. But this case has never been about protecting women, it’s about outlawing abortion, so the plaintiffs are happy to seek a court order that would put more women at risk.
I live in a red state where mifepristone is illegal already. Does that mean I can’t get a medication abortion?
You can, it just wouldn’t be strictly legal. It’s easy to obtain mifepristone and misoprostol online through a flourishing gray market regardless of where you live. International providers, whose supply appears to be safe and reliable, will mail it to your door. The most popular provider is Aid Access, which is led by a Dutch physician who mails the pills from India. Tens of thousands of Americans have safely terminated their pregnancies with the help of Aid Access since the Supreme Court overturned Roe v. Wade. All red states do criminalize the use of overseas abortion pills—either through a direct ban or application of other laws like the unauthorized practice of medicine. And anti-abortion advocates are currently lobbying red state prosecutors to investigate and charge people who use or provide these pills, though they’ve had no success so far.
Last question: I thought America being in a constitutional crisis would be more obvious, or feel like a bigger deal? What is going to happen next, and how much worse could it get?
Well first, it could get a lot worse! Republicans are increasingly seeking carceral solutions to the ongoing, widespread availability of medication abortion. One activist has filed a lawsuit attempting to bankrupt several Texas women who helped their friend obtain mifepristone. Conservatives will keep enlisting courts, prosecutors, and prisons to crack down on these pills even if their frontal assault on FDA approval fails.
The people fomenting this constitutional crisis are smart enough to push it forward step by step. It will not happen all at once, but instead unfurl slowly, so that most Americans don’t realize it’s happening until it threatens them directly. (One reason this case has gotten so much attention is that it has caused residents of blue states to understand the stakes here.) A bare-knuckled power struggle within the judiciary is an omen of more frighteningly antidemocratic maneuvers to come. By the time you feel this crisis yourself, it may be too late to stop.
