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Next phase in the medication abortion fight will be a quick-moving legal battle

<i>Evelyn Hockstein/Reuters/File</i><br/>Used boxes of Mifepristone pills
Evelyn Hockstein/Reuters/File
Used boxes of Mifepristone pills

By Tierney Sneed, CNN

A seven-day clock is ticking for the Biden administration and higher courts to address an untenable situation around medication abortion — one created by rival federal court rulings from judges in separate corners of the country.

While it’s not unusual for lower courts to disagree on major legal questions, the contradicting orders that came down Friday — within less than an hour of each other — marked the most high-pitched legal battle over abortion access since the Supreme Court reversed Roe v. Wade last year.

The Justice Department and a manufacturer of medication abortion drugs asked a federal appeals court on Monday to put on hold an order halting the US Food and Drug Administration’s approval of mifepristone, the first drug used in the medication abortion process.

The requests, filed on Monday before the US 5th Circuit Court of Appeals, are seeking a short-term administrative stay as well as a long-term stay pending appeal on a lower court ruling from US District Judge Matthew Kacsmaryk, who ordered the FDA’s approval of the drug to be suspended.

The Justice Department is asking for the 5th Circuit to act on its emergency request by noon Thursday, “to enable the government to seek relief in the Supreme Court if necessary.”

US Health and Human Services Secretary Xavier Becerra told CNN on Sunday that the administration intended to do everything it could to ensure that women have access to abortion pills “not just in a week — but moving forward, period.”

He said that “everything is on the table,” when asked if the FDA could ignore the ruling — a comment later walked back by a department spokesperson.

In the case in question, a lawsuit brought by anti-abortion activists in Texas, a judge said Friday that he was suspending the longstanding approval of the drug, but delayed his order by seven days to give the government time to seek a higher court’s intervention.

Less than an hour later, a federal judge in Washington state — who is overseeing a lawsuit brought by state Democratic attorneys general seeking to expand access to abortion pills — issued an order barring the FDA from taking any steps to reduce the drug’s availability. That order applies in the 18 jurisdictions that brought the lawsuit, but would seem to conflict with the Texas order, which applies nationwide.

Mifepristone was approved by the FDA nearly 23 years ago and medication abortion makes up the majority of abortions in the United States. Leading medical organizations have vehemently pushed back on the Texas judge’s assertions that the drug is unsafe.

Regardless of the exact procedural route, the next couple of days stand to be dramatic, and feature a flurry of court filings and high-stakes decisions that might be handed down with only limited explanation.

Even without the rival ruling from the judge in Washington state, Kacsmaryk’s decision to halt the 2000 approval is an unprecedented move, and one — if allowed to go into effect — that will inject significant uncertainty and confusion into what is already a tumultuous legal landscape around abortion.

The DOJ has not indicated how it will respond to the order from the Washington judge, US District Judge Thomas O. Rice. The department may be inclined to appeal it, so to wipe away a court order that also inserted a judge into FDA decision-making. But the department may opt to forgo emergency litigation over whether Rice’s order should be paused in the meantime.

On Monday, the Justice Department asked Rice to clarify how FDA should comply with his order if Kacsmaryk’s ruling is allowed to go into effect, with a filing that pointed to a “significant tension” between the two rulings. It’s asking Rice to clarify his ruling by Friday, ahead of when the Kacsmaryk order is scheduled to take affect absent an intervention from a higher court.

Uncertainty over how the ruling against abortion pills would be carried out

As even anti-abortion rights activists who brought the case have had to acknowledge, it is unprecedented for a federal judge to ordered a drug off the market that’s been approved for decades.

If Kacmsaryk’s ruling goes into effect, it raises a bevy of questions about how the order is supposed to be implemented, particularly while the FDA is under the separate judicial command to not reduce the drug’s availability in a large swath of the county.

Kacsmaryk’s opinion did not add clarity to this question. He is invoking a legal mechanism to halt the drug’s approval that was not among the remedies the plaintiffs were seeking.

One major question is how providers, distributors and manufacturers who were not party to the Texas case should respond to the order.

While mifepristone manufacturer Danco intervened as a defendant in the case, the other major manufacturer, GenBioPro, did not and is not a party in the litigation. GenBioPro said in a statement about the ruling Friday night it is “reviewing the court’s order in detail.”

“Nothing in the court’s order changes the decades of science and evidence regarding mifepristone’s safety and efficacy,” GenBioPro CEO Evan Masingill said in the statement. “As we review the court’s order, we will continue to make our product available. We will take any steps necessary to lawfully make mifepristone available and accessible to as many people as possible in the country.”

Legal experts have told CNN that, without any direction from the FDA otherwise, providers and distributors have no obligation to stop prescribing and dispensing mifepristone for abortions. A medication abortion regimen of only misoprostol — the second drug in the FDA-approved process — is also a potential option for providers to prescribe to patients seeking to terminate their pregnancies.

But the confusion and uncertainty about the effects of Kacsmaryk’s order stand to have a chilling effect on providers and patients.

Providers are already telling CNN that, even though Kacsmaryk’s ruling is not into effect, they’re changing the care and counsel they’re offering patients.

Against this backdrop, some Democrats are calling on the Biden administration to ignore the FDA’s ruling.

“I believe that the Biden administration should ignore this ruling,” Democratic Rep. Alexandria Ocasio-Cortez of New York told CNN on Friday. “The courts have the legitimacy and they rely on the legitimacy of their rulings, and what they are currently doing is engaged in an unprecedented and dramatic erosion of the legitimacy of the courts.”

Legal experts have argued that FDA has the option to issue non-enforcement guidance that could provide some solace to providers and others in the drug’s supply chain, but it’s unclear whether the agency is considering that option.

The administration has so far emphasized its fight against the ruling will be a legal response through the appeals in court.

This story has been updated with additional information.

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