The Biden administration is asking the Supreme Court to restore access to abortion pills

One of the drug’s makers, Danco Laboratories, also asked the justices to overturn the appeals court’s decision and maintain existing access to the drug for the time being. The appeals court’s actions “created regulatory chaos across the country,” the company’s lawyers said.

The urgent appeals stem from a ruling last week by a federal district court judge in Texas and a subsequent ruling Wednesday by the New Orleans-based 5th Circuit Court of Appeals. Texas-based Judge Matthew Kaczmarik said the FDA’s 23-year-old approval of mifepristone — as well as the agency’s more recent policies to expand access to the drug — should be ended. A three-judge panel of the 5th Circuit blocked the part of Kacsmaryk’s ruling that suspended the original approval, but the panel agreed with him that policies expanding access should be put on hold.

Those policies, among other things, authorized a generic version of mifepristone and allowed the drug to be mailed, prescribed via telemedicine, and dispensed at retail pharmacies. The policies also expanded the drug’s approved use during the first 10 weeks of pregnancy, compared to the first seven weeks.

The Justice Department and Danco sent their requests to Judge Samuel Alito, who initially handles emergency appeals from the 5th Circuit. Alito is likely to take the requests to the full Supreme Court.

Without action from the Supreme Court, the 5th Circuit ruling is scheduled to take effect Saturday, and access to mifepristone — which is used in more than half of abortions nationwide — could be immediately curtailed.

The Justice Department complained that the “arbitrarily shortened” terms set by lower courts had unintended consequences that could put women at risk.

“Issues of such imperative public importance should not be addressed in this manner,” Prelogar wrote on behalf of the US government.

Danko argued in his appeal that while the 5th Circuit’s decision technically left the FDA’s initial approval of mifepristone in place, it could function as a temporary ban on the drug in practice.

It would be “extremely difficult, if not impossible” for Danco to continue making and selling mifepristone if the Supreme Court did not intervene, the company’s lawyers wrote.

That’s because the company may have to stop distributing the drug entirely for a while as the drug’s official labeling must be revised to comply with the court’s directive, a process that could take months. Meanwhile, selling the drug in its old packaging could be considered a crime, the company said.

The drugmaker also said it faces a potential catch-22: It needs approval for new labels and other materials to comply with the 5th Circuit’s directive, but the FDA may not be able to grant that approval because of a separate order from a judge in Washington State prohibits the FDA from taking any action to limit access to the drug in many states.

“In the face of this uncertainty, Danco may be forced to cease operations,” the company said.

Both Danko and the Justice Department highlighted the confusion created by the conflicting court orders. While the 5th Circuit ordered access to the drug revoked nationwide, Washington Judge Thomas Rice ordered the FDA to maintain the current level of access to the drug in 17 states and Washington

“FDA faces a clear threat of irreparable harm from conflicting court orders,” Prelogar wrote.

“The result is an unstoppable impasse for Danco, for providers, for women and for health care systems trying to navigate these uncharted waters,” the firm’s lawyers added.

Danko and the Justice Department also argued that the anti-abortion doctors who brought the challenge lacked standing to do so, disputing that they faced immediate harm from potentially having to treat patients who took the pills and had a complication.

“Their claims of future harm amount to nothing more than a general statistical possibility that, out of the universe of all women who may seek medical abortion, one of their member physicians will be ‘forced’ to treat such a woman sometime, somewhere,” They write Danko’s attorneys, adding, “A doctor’s job is to treat patients. This is true regardless of whether the doctor agrees with the patient’s choice that prompted him to seek medical attention.

A lawyer who represents anti-abortion groups challenging the abortion pill said in a statement Friday that her team will ask the justices to allow the lower court rulings to stand.

“The FDA has illegally approved chemical abortion drugs and shirked its legal responsibility to answer the questions of the American people for two decades,” said Erin Hawley, senior counsel at the Alliance Defending Freedom. “The 5th Circuit correctly required the agency to prioritize women’s health by restoring critical safeguards, and we will urge the Supreme Court to uphold that accountability.”

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