The Biden administration has joined an appeal to the US Supreme Court to preserve access to the abortion drug mifepristone as the case makes its way up the legal ladder.
Both the US Department of Justice and Danco Laboratories, the manufacturer of the drug, filed requests with the Supreme Court two days after a lower court tightened rules around the drug but maintained access to it.
The briefing from the Justice Department asked for a stay to maintain the status quo as the court considers the appeal.
“The government also respectfully requests an mediate administrative stay to preserve the status quo while the Court considers this application,” the briefing reads.
“More than five million Americans have ended their pregnancies using the drug,” the briefing says. “Today, more than half of women in this country who choose to terminate their pregnancies rely on mifepristone to do so.”
The briefing also criticised the plaintiffs in the original Texas case for their extraordinary actions to halt the drug’s approval.
“They did not sue until more than two decades after mifepristone’s approval, delayed three years before petitioning FDA to reconsider its modifications to the conditions on mifepristone’s distribution, waited nearly a year to sue after FDA denied that petition, and then unsuccessfully urged the district court to defer consideration of preliminary relief until after a trial on the merits,” the briefing said.
The move from the Biden administration comes after the US 5th Circuit Court of Appeals in New Orleans granted a request from the US Department of Justice to put on hold a ruling from US US District Judge Matthew Kacsmaryk that blocked the US Food and Drug Administration’s approval of mifepristone.
Danco Laborities excoriated the ruling in the Fifth Circuit in its briefing, saying it caused “regulatory chaos.”
“ The direct consequence of the Fifth Circuit’s ruling is that FDA must effectuate a series of extensive approvals to implement the Fifth Circuit’s rollback,” the briefing said. “Without those approvals, Danco cannot legally market and distribute mifepristone.”
As of right now, the drug remains on the market. But the court of appeals made it harder for Americas to obtain, as it rolled back regulations that the FDA loosened to expand access to the drug.
The FDA had previously expanded approval for the drug for up to 10 weeks of pregnancy, but the court of appeals ruling reduced that to seven weeks.
“As far as the record before us reveals, FDA has not structured the distribution of any comparable drug in this way,” the three-judge panel said in its ruling.
US Attorney General Merrick Garland said on Thursday that the Justice Department would “be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”
The briefing said the rolled back rules could have serious implications.
“If allowed to take effect, the lower courts’ orders would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority,” it said. “ The resulting disruption would deny women lawful access to a drug FDA deemed a safe and effective alternative to invasive surgical abortion.”
The ruling came after Judge Kacsmaryk issued a ruling revoking the FDA’s 23-year approval of the drug. The drug is taken in conjunction with a second drug called misoprostol.
The new rules would take place by Saturday if the court does not take action.
Alex Woodward and Rachel Sharp contributed reporting.
