For weeks, abortion rights advocates have been waiting for a potential bombshell: A conservative federal judge in Texas is expected to effectively outlaw the most popular method of abortion nationwide.
Now, the day may finally be here. Judge Matthew Kacsmaryk, a Donald Trump appointee affiliated with the religious right, scheduled a hearing in the lawsuit challenging the FDA approval of mifepristone—the medication used in some 50 percent of abortions—for Wednesday morning. After the hearing, Kacsmaryk could issue a temporary injunction at any time.
The late notice of the hearing is “highly unusual,” as the Washington Post reported Saturday. In an unannounced call with lawyers on both sides of the case on Friday, Kacsmaryk requested they keep the upcoming hearing secret to avoid an “unnecessary circus-like atmosphere” at the courthouse, explaining that the case had already brought “a barrage of death threats and protesters and the rest,” according to a transcript of the hearing. Kacsmaryk had originally planned not to place the hearing on the public court docket until Tuesday afternoon—making it difficult for media or other members of the public to get to the remote Amarillo courthouse. But after the Washington Post reported on the plans and a coalition of media organizations filed an objection, Kacsmaryk quietly placed a notice about the upcoming hearing on the docket.
The lawsuit Kacsmaryk is considering was brought by the Alliance Defending Freedom, the conservative Christian legal behemoth that drafted the Mississippi abortion ban at the heart of the case that overturned Roe v. Wade. The complaint, filed on behalf of four doctors and a handful of anti-abortion medical organizations, claimed that the FDA had overlooked potentially harmful side effects when it green-lit mifepristone 23 years ago. (According to the FDA, the original approval of mifepristone was based on “a thorough and comprehensive review of the scientific evidence” that found the drug was “safe and effective” when used as directed, and follow-up data in the ensuing years has turned up no new safety concerns.) In addition, the lawsuit argues the FDA’s approval “exceeded its regulatory authority” in part because pregnancy is not an “illness,” and also because an 1873 federal law made it a crime to distribute “obscene, lewd or lascivious” material through the mail, including “any article or thing” intended to be used for abortion.
The arguments in the case are seen by legal experts as a stretch, and that’s being generous. But in a strategic move, Alliance Defending Freedom filed the complaint in Amarillo, Texas—virtually guaranteeing that it would be heard by Judge Kacsmaryk. A former staff attorney for a religious-right legal firm, the controversial judge was already known for making anti-abortion and anti-LGBTQ statements at the time he was nominated by Trump and confirmed by a Republican Senate. Since then, conservative legal activists have been lining up to send him their cases—and he’s delivered, forcing the Biden administration to reinstate Trump’s “Remain in Mexico” border policy. In two cases late last year, Kacsmaryk ruled that anti-LGBTQ discrimination was permissible in heath care and struck down a rule that had promised confidentiality to teens who sought birth control from federally funded family planning programs. Both lawsuits happen to have been filed by former Texas solicitor general Jonathan Mitchell, the architect of the state’s 6-week abortion ban and its “bounty hunter” enforcement mechanism.
The medication at issue in the lawsuit, sold under the brand name Mifeprex, has been approved by the FDA for over two decades as part of a two-drug regimen to end pregnancies within the first 10 weeks. Mifepristone blocks the hormone progesterone, causing pregnant peoples’ uterine lining and implanted embryo to begin breaking down. The second drug in the regimen, the anti-ulcer drug misoprostol, is taken 24 to 48 hours later to soften the cervix and cause contractions. The drugs can be taken safely at home and are successful in 99.6 percent of cases, according to the National Academies of Sciences, Engineering, and Medicine.
Despite mifepristone’s sterling safety record, the FDA has long placed extra restrictions on it, such as a requirement that heath care providers receive a special certification in order to prescribe it. Over the years, the agency has rolled back some of its rules, making medication abortion more accessible; by 2020 it accounted for 53 percent of all facility-based abortions, according to the Guttmacher Institute. Last year, the FDA made a pandemic-era rule change permanent, allowing providers to prescribe mifepristone via telehealth and send patients abortion pills through the mail. And in January, the FDA tweaked the rules again, allowing specially certified pharmacies to distribute it.
Medication abortion was hailed as the future of abortion after the Supreme Court ruled last June that people did not have a constitutional right to end their pregnancy. “Despite the power of the imagery, the end of legal abortion would not mean a return to back alleys and coat hangers, but pills and women taking their reproductive lives into their own hands,” my colleague Becca Andrews wrote last year. The pills, after all, are safe, effective, and easily transported by mail, though a plethora of state laws have attempted to block that practice.
Its popularity makes it a target of conservative attacks. But some legal experts argue that if Kacsmaryk tries to ban mifepristone, the FDA wouldn’t be required to enforce the decision and pull the drug from the market, at least not right away. And Sen. Ron Wyden had urged the White House to “ignore” an abortion-hostile ruling from Kacsmaryk: “Don’t give in to the courtwashing. Protect the fundamental rights and wellbeing of all women in America. The FDA should go on just as it has for the last 23 years since it first approved mifepristone.”
With mifepristone’s approval revoked, more pregnant people would be expected to seek resource-intensive surgical abortions, adding to the overload of patients at clinics in states where abortion remains legal. Many providers plan to begin offering off-label, misoprostol-only abortions. Though somewhat less effective than the two-drug regimen, the misoprostol-only regimen is well-studied and used around the world in places where mifepristone is unavailable. (The World Health Organization supports using misoprostol alone to end pregnancy and publishes guidelines on how to do so safely.) Planned Parenthood, Abortion on Demand, Aid Access, Carafem, Choix, Forward Midwifery, Hey Jane, and Just the Pill are all prepared to offer misoprostol-only abortions, according to Susan Rinkunas of Jezebel.
If Kacsmaryk bans mifepristone, the order would be temporary, for now. But any appeal of the ruling would go to the Fifth Circuit Court of Appeals, the most conservative circuit in the country—and then onto a Supreme Court still ruled by the majority that overturned Roe v. Wade.