Updated April 19 at 3:30 p.m.
The Supreme Court pushed the temporarily stay on an appellate court's mifepristone ruling to late Friday, according to a Wednesday order issued by Justice Sameul Alito.
The top court is currently considering filings from stakeholders—including drugmakers, the plaintiff anti-abortion medical group and the Biden administration—before it makes a decision on restrictions ordered by lower courts.
The temporary stay now expires at 11:59 p.m. on Friday, barring another extension.
April 14
The Supreme Court has placed a temporary hold on an appellate court ruling that restricts access to the abortion drug mifepristone.
Justice Samuel Alito issued an emergency ruling on Friday that stays a decision by the Fifth Circuit Court of Appeals until an emergency briefing on Wednesday. The decision comes after mifepristone maker Danco and the Department of Justice filed emergency requests with the court.
Drug maker Danco filed its emergency request on Friday for a stay of the federal appellate court ruling that was supposed to take effect this weekend.
“The Fifth Circuit’s unprecedented order has created regulatory chaos across the country,” the manufacturer said in the filing.
The court ruled that while mifepristone can remain on the market, it cannot be distributed by mail. It also cannot be prescribed for pregnancies at 10 weeks, reverting back to an earlier requirement of seven weeks.
The Fifth Circuit did overrule a lower court’s decision to suspend the Food and Drug Administration approval for mifepristone, which has been on the market since 2000.
Danco argues that the restrictions though are going to cause a massive “untenable limbo” for the healthcare industry.
FDA, for instance, has to “effectuate a series of extensive approvals to implement the Fifth Circuit’s rollback,” the filing said. “Without those approvals, Danco cannot legally market and distribute mifepristone.”
However, FDA is also under a court order from a federal judge in Washington from making any changes to the regulation and approval of mifepristone in 17 states and the District of Columbia. This is going to cause providers and systems to navigate “uncharted waters,” Danco wrote.
Danco's filing comes as prescriptions for the drug and misoprosotol have increased after the Supreme Court overturned Roe v. Wade last year.
The drug manufacturer also slammed the ruling for overturning settled precedent.
The appellate court took the FDA to task for removing an in-person dispensing requirement in 2016 and changed when the drug can be prescribed from a pregnancy of seven weeks to ten weeks. The court ruled that the FDA changed the drug’s approval but did not incorporate any studies into the exact boundaries of the modified approval.
But Danco said the court should have deferred to FDA’s expertise in evaluating data from dozens of clinical trials.
“The pharmaceutical industry could not have been clearer that such a judicial imposition on FDA of this sort of rigid matching requirement, untethered to anything in the statute or regulations, would be devastating,” Danco wrote. “If that were the rule governing FDA approvals, it would be unlikely that any drug on the market is properly approved.”
Danco called for the high court to stay the appellate court’s and lower court’s rulings in full pending an appeal. It should also have an expedited briefing and argument before the summer recess.
The case centers on a lawsuit brought by the anti-abortion group Alliance for Hippocratic Medicine. A lower court ruled that the FDA did not properly take into account the side effects of mifepristone and ignored for decades citizen petitions to strip its approval.
Judge Matt Kaczymaryk originally had stayed his ruling for a week to give the DOJ time to seek an emergency order from the Fifth Circuit.
The lower court applied the ruling nationwide, while the contradictory Washington ruling only applies to the states which sued for relief.