How A Texas Lawsuit Could Alter Mifepristone Access in U.S.
The future of medication abortions across the U.S.—even in states with few abortion restrictions—is on the line. Experts call a recent, soon-to-be-decided lawsuit the most consequential court case for nationwide abortion access since the overturning of Roe v. Wade.
A ruling is expected as soon as Feb. 24. Here’s what to know about the case.
What the lawsuit says
The suit, filed Nov. 18, 2022 on behalf of the anti-abortion physician’s group Alliance for Hippocratic Medicine (AHM), seeks to overturn the U.S. Food and Drug Administration (FDA)’s approval of mifepristone: one of the two prescription pills that are typically used in combination to terminate pregnancies, and which account for more than half of all U.S. abortions. AHM holds that the FDA “failed America’s women and girls” because the regulator approved mifepristone via an “accelerated” process more than two decades ago. The FDA has stated that mifepristone was approved within the guidelines at the time and has continued to be evaluated and regulated appropriately.
The lawsuit is being tried during a confusing time for medication abortion access. Recently, the Biden Administration made moves to expand legal access to the pills; in early January, the FDA released new rules allowing all pharmacies to offer mifepristone, and in 2021, the agency abolished an in-person appointment requirement, which allowed doctors to prescribe the medication remotely and for patients to receive it via mail.
Read More: What to Know About Abortion Pills Post-Roe
Abortion-rights advocates are particularly concerned about the AHM’s decision to file the suit in Amarillo, Texas, where Judge Matthew Kacsmaryk was confirmed to a lifetime federal appointment in 2019. Of all federal judges appointed by former President Donald Trump, Kacsmaryk’s views are believed to be among the more openly conservative and driven by Christian dogma.
The practice of judge shopping, where political and religious organizations like the AHM specifically seek out jurisdictions with judges that they believe are likely to hand out the results they want, has kept Kacsmaryk particularly busy in Amarillo, Vox reports. During his tenure, Kacsmaryk has worked to thwart the Biden Administration’s attempts at loosening immigration restrictions, to prevent the adoption of guidelines that would protect transgender people in the workplace, and to require parental approval for minors in Texas to obtain federally funded birth control, among other conservative goals. It’s “not surprising” that this case, too, has ended up before the judge, says Texas state representative Donna Howard, who is a Democrat. “It’s pretty frightening in terms of the potential implications not only for those of us in Texas, but for the entire country.”
What is mifepristone, and why is it being targeted?
Mifepristone is a progesterone-blocking pill used to initiate endometrial shedding and essentially dislodge a pregnancy. The FDA first approved it in 2000, and since then, doctors have widely considered the combination of mifepristone and another medication called misoprostol the gold standard for safe abortion care. The two-step regimen, which is approved for use at up to 10 weeks of pregnancy, has become so common that it now accounts for more than half of abortions in the U.S., according to the Guttmacher Institute.
Although misoprostol-only abortions have also proven to be safe and effective (a recent study put the single-pill regimen’s success rate at 88% for pregnancies up to 10 weeks), they can be slightly more painful.
Misoprostol is an FDA-approval ulcer treatment, but its ability to prompt cervical contractions and dilation mean that it’s used off-label to assist with abortions, inducing labor, inserting IUDs, and a number of other reproductive health purposes. Mifepristone, by contrast, has been specifically approved for use in medicated abortion, and has fewer other uses, making it an easier target for groups looking to complicate and reduce access to reliable abortion care.
When will it be decided?
Though a ruling was initially expected as early as Feb. 10, the judge overseeing the case has given AHM until Feb. 24 to respond to the opposition statements submitted by Danco Laboratories, the manufacturer of Mifeprex (mifepristone’s brand-name variety). Both Danco and the FDA filed formal complaints against the suit in January, while GenBioPro, the maker of generic mifepristone, remains embroiled in a separate January lawsuit challenging West Virginia’s statewide ban of the drug—a case that the outcome of the Texas suit could now affect.
If the Texas case is decided in favor of AHM, mifepristone could be taken off the market in all 50 states. A recent release from NARAL Pro-Choice America estimates that 64.5 million American women would lose access to medication abortion care if FDA approval of the drug is revoked (though Americans would likely still be able to mail-order the pills from organizations outside the U.S., a practice that remains a legal gray area.)
Angela Vasquez-Giroux, vice president of communications and research at NARAL, says the reproductive rights community has interpreted the two-week extension of the ruling deadline as a bit of a “reprieve” in a stressful litigation process. “No one was expecting to get this two-week extension,” she says. But, perhaps counterintuitively, given that the decision may have been made to buy time for AHM’s final response, it’s also been helpful for the other side, Vasquez-Giroux says. “Ultimately, it’s allowing us more time to educate more people about what the case is, and what’s at stake.”
With the extension comes the opportunity for more groups and officials to weigh in before the case is decided. The list of briefs shared with Texas courts grew overnight after the extension was announced Feb. 9. Among them are a brief signed by 67 U.S. congresspeople and another from a collection of 22 Republican state attorneys general, both challenging the FDA’s grounds for originally approving mifepristone. On the other side, 22 Democratic attorneys general filed a brief citing the drug’s long track record of being safe, effective, and closely monitored by the FDA.
Legal experts have suggested that the basis of AHM’s case is shaky, and that many other federal judges would be unlikely to agree to hear it due to the length of time that mifepristone has been in use and its positive safety profile. The FDA has kept a close eye on the drug, reevaluating it periodically in its Risk Evaluation and Mitigation Strategy program. But the politicization of the case makes it less of a long shot than it might be for the average medication with a similar safety profile to mifepristone. Even if Kacsmaryk does rule in favor of the FDA, the case is likely to make its way up to the U.S. Supreme Court via the overwhelmingly conservative Fifth Circuit Court of Appeals.
Vasquez-Giroux hopes that voters who supported access to abortion don’t “automatically turn their ears off” because the suit is coming out of Texas. “The thing that is most upsetting and shocking for folks, when they do find out about this,” she says, “is learning that this would override their votes and their desires in blue states.”
Health care providers across the country are taking the threat seriously by preparing to offer misoprostol-only abortions if needed. Even if it doesn’t come to that, experts say, any outcome that forces underfunded clinics to reassess the services they’re legally able to provide could mean some individuals missing out on services in the short term.
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