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Appeals court set to rule anytime on high-stakes abortion pill case

The Justice Department has fired back at anti-abortion groups' argument that no harm would result from letting a ruling invalidating FDA approval of mifepristone go into effect.

The anti-abortion groups at the center of a closely watched Texas lawsuit over access to an abortion pill traded barbs with the Biden administration Wednesday as a federal appeals court could weigh in anytime on the controversial ruling that could endanger access to the medication.

The groups argued in a filing overnight that no harm results from the 5th U.S. Circuit Court of Appeals’ letting Judge Matthew J. Kacsmaryk’s order invalidating the Food and Drug Administration’s 23-year-old approval of mifepristone go into effect.

The groups had challenged how the drug was originally approved and claimed the FDA ignored safety risks — which it vigorously disputes.

Kacsmaryk’s ruling was “meticulously considered,” the plaintiffs argued.

“[T]he order merely removes mifepristone from the mails and the market,” lawyers for the plaintiffs wrote. “[A]bortion will still be available in states that permit it.”

The Justice Department fired back Wednesday, arguing that if the ruling is “allowed to take effect, the court’s order will cause irreparable harm across the country.” 

“The district court purported to be acting in a restrained manner; but there is nothing modest about upending the decades-long status quo by blocking access nationwide to a safe and effective drug,” Justice Department lawyers argued.

Mifepristone is part of the standard two-pill regimen for medication abortions. Democratic governors in New York and California announced plans this week to stockpile misoprostol, the second drug in the regimen. But it’s slightly less effective when taken alone, and it can cause more cramping and bleeding. The plaintiffs also want misoprostol banned, but it wasn’t part of their original injunction request and isn’t covered by Kacsmaryk’s decision.  

The Justice Department and Danco Laboratories, which manufactures a brand of mifepristone, have asked the 5th Circuit to issue an “administrative stay” of Kacsmaryk’s ruling to allow more time for the legal process to play out, as well as a longer pause on the ruling during the appeals process.

The court could rule at any time. Kacsmaryk’s ruling is set to go into effect early Saturday barring intervention from the court.

A conflicting ruling from U.S. District Judge Thomas Rice in Washington state, however, has caused some uncertainty about the immediate practical and legal effect of Kacsmaryk’s decision. Rice’s ruling requires the FDA to keep mifepristone on the market, and the Justice Department has asked him to provide guidance on how to reconcile his order with Kacsmaryk’s decision. 

The Biden administration has condemned Kacsmaryk’s ruling, as has a coalition of more than 600 drugmakers, biotech leaders and pharmaceutical advisers, some of whom weighed in with their own brief late Tuesday.

“Far from being limited to one drug, the logic of the district court’s order overturns the long-settled legal basis of FDA’s drug-approval process. Unless stayed, the district court’s lawless opinion will empower any plaintiff to grind drug approvals to a halt, disrupting patients’ access to critical medicines,” they wrote.

The case has also produced a flurry of amicus court filings from outside advocacy groups, physicians associations, Democratic and Republican lawmakers and former Justice Department officials across the ideological spectrum — all racing to have their say before the 5th Circuit issues a decision.