A Federal Judge in Amarillo Just Suspended Approval of a Key Drug Used in Medication Abortions. But the Situation Is Complicated. 

On Friday morning, Matthew J. Kacsmaryk, a federal judge in the Northern District of Texas, issued an unprecedented ruling: he granted an injunction staying the Food and Drug Administration’s two-decade-old approval of mifepristone, one of the two drugs that patients across the country use in combination to terminate early-stage pregnancies at home. Access to the pill, which was already banned in Texas, may now be restricted across the country. 

Mifepristone was first approved by the FDA in 2000. Those bringing the lawsuit Kacsmaryk ruled on, a collection of anti-abortion organizations, acknowledged that the drug has been administered for decades. However, plaintiffs argued that the FDA exceeded its authority when it approved the drug in 2000 because “pregnancy is not an illness,” and claimed the agency ignored “intense side effects,” despite the drug having been used safely for more than twenty years. There is no precedent for a judge reversing a decades-long FDA approval for a drug that has been safely administered. Nonetheless, Kacsmaryk, an anti-abortion conservative nominated by Donald Trump in 2017, issued the ruling, declaring that the FDA improperly approved the drug. 

Kacsmaryk’s ruling acknowledges that the Biden administration is likely to appeal this decision; accordingly, his ruling allows for a seven-day delay, during which the pill can be accessed, for the Fifth Circuit Court of Appeals to intervene. If it does not, mifepristone could be blocked from distribution around the country, effective April 14. Kacsmaryk’s decision is complicated, however, by another federal district judge’s ruling in a separate lawsuit against the FDA brought in Washington. There, seventeen states, as well as the District of Columbia, sought an injunction against the federal agency that would prevent it from making any changes to the approval status of mifepristone; that injunction was also granted, leaving the agency facing two contradictory orders. Both an appellate lawyer and a reproductive rights lawyer reached by Texas Monthly were uncertain what the conflicting rulings would mean for the drug’s availability.

Should the Biden administration appeal immediately, and should the Fifth Circuit overturn Kacsmaryk’s ruling, mifepristone will remain legal. The Fifth Circuit has a history of approving abortion restrictions, however, including those that the Supreme Court later finds unconstitutional. If either of those things does not happen, the conflict between the two federal district court decisions will need to be resolved at the Supreme Court, leaving the status of the drug once more in limbo. (The FDA could also appeal the Washington judge’s decision to the Ninth Circuit Court of Appeals, though it’s unclear why the agency would do so.) 

All of this creates a great deal of uncertainty and puts those who seek abortions in a complicated situation. Mifepristone is administered in conjunction with the ulcer drug misoprostol, which was not included in this lawsuit, and which was approved by the FDA in 1988. The two drugs together are 95 percent effective at terminating pregnancies before nine weeks. Misoprostol on its own, meanwhile, has been found to be somewhat less effective, at 88 percent. Should Kacsmaryk’s ruling go into effect, adapting to a different treatment regimen that offers a lower standard of care to patients will put doctors in an unusual position. 

“The burden on patients will be astronomical in both costs, time away from work and family, and speedy access to care,” Sonja Spoo, director of reproductive rights campaigns at the gender justice advocacy organization UltraViolet, told Texas Monthly. “Patients deserve the right to the full spectrum of treatment options that have been approved by the FDA, which are proven safe and effective.” 

Nonsurgical abortions are now the most common method for patients who seek the procedure, particularly in Texas, where surgical abortions are banned. According to a 2022 study from the Guttmacher Institute, 53 percent of all facility-based abortions are induced through medication. The drugs are cheaper, faster, and less invasive than a surgical procedure—especially as, in states where abortion remains legal, out-of-state patients have taxed the capacity of clinics to keep up with patient demand. “Understand this is all by design,” Spoo said. “The anti-abortion movement wants to make abortion completely unavailable and will not rest until that is true—no matter who is harmed.” 

The case didn’t land in Kacsmaryk’s courtroom by accident. Texas’s rules governing federal courts assign all cases filed in the city to him, and his reputation as an advocate from the bench for right-wing causes makes Amarillo an attractive venue for conservative plaintiffs seeking a friendly jurist. However, Kacsmaryk’s ruling could eventually end up being among the last that he makes in a case that was tailored specifically for him. In February, the Department of Justice filed a motion seeking to move yet another case that was filed in Amarillo with the intention of getting a favorable ruling from Kacsmaryk, arguing that “the public’s interest in the fair administration of justice would be harmed if a filing with strong indicia of judge shopping were left unchecked,” and that, because no party in that case lives in Amarillo, Kacsmaryk’s courtroom is an inappropriate venue for the case. That motion will be heard by Kacsmaryk himself, who will probably not be sympathetic to the idea that he’s a biased judge—but it will create a chain of appeal that can be pursued up to the Supreme Court, which has shown some interest in maintaining Americans’ confidence in the judiciary. 

Until then, venue shopping in Kaczmaryk’s court appears to have worked for the anti-abortion movement. Mifepristone is legal until April 14, at which point the Fifth Circuit could either overturn Kacsmaryk’s ruling or leave it in place. What comes after next week is unclear. Barring the court striking down Kacsmaryk, and given the unusual nature of a situation in which two district courts have given a federal agency contradictory orders, the question of whether mifepristone will continue to be available remains unsettled.