Access to the common abortion pill mifepristone will remain unchanged, for now, after the Supreme Court sided Friday with the Biden administration and paused a lower court ruling.
The justices, in a brief order, said they will put on hold a ruling from a Texas federal judge while the Biden administration’s appeal proceeds.
The decision is a temporary victory for the Biden administration that for now, keeps the Food and Drug Administration’s authority on drug approvals.
Justices Clarence Thomas and Samuel Alito, two of the court’s conservatives, said they would have denied the request for a pause.
“As a result of the Supreme Court’s stay, mifepristone remains available and approved for safe and effective use while we continue this fight in the courts,” President Biden said in a statement.
“I continue to stand by FDA’s evidence-based approval of mifepristone, and my administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs,” Biden said.
Biden reiterated his calls for the public to elect more pro-abortion lawmakers.
“The American people must continue to use their vote as their voice, and elect a Congress who will pass a law restoring the protections of Roe v Wade,” Biden said.
Alito, in dissent, wrote that his position did not reflect any view on the merits of FDA’s mifepristone actions. He noted past criticisms levied against the court’s use of the so-called shadow docket, referring to when the high court issues emergency rulings without oral argument or a significant record.
“I did not agree with these criticisms at the time, but if they were warranted in the cases in which they were made, they are emphatically true here,” Alito wrote.
On April 7, U.S. District Judge Matthew Kacsmaryk suspended the Food and Drug Administration’s 23-year-old approval of mifepristone. Kacsmaryk ruled the agency’s approval process was improperly rushed and resulted in an unsafe drug regimen getting on the market.
The 5th U.S. Circuit Court of Appeals last week paused part of Kacsmaryk’s ruling until it considers the government’s appeal, temporarily preserving the FDA’s original approval of mifepristone. But it left in place another part of the ruling that blocked steps the FDA has taken since 2016 to ease access to mifepristone.
“As is common practice, the Supreme Court has decided to maintain the status quo that existed prior to our lawsuit while our challenge to the FDA’s illegal approval of chemical abortion drugs and its removal of critical safeguards for those drugs moves forward,” said Erik Baptist, senior counsel at Alliance Defending Freedom, the legal group representing the mifepristone challengers.
“Our case seeking to put women’s health above politics continues on an expedited basis in the lower courts,” he said in a statement.
The high court’s emergency order pauses those remaining portions, which would have otherwise gone into effect Friday night.
Those preserved changes include allowing mifepristone to be sent through the mail, lifting a requirement for three in-person visits, approving a generic, and approving the drug’s use up to 10 weeks into a pregnancy, rather than seven weeks.
Danco Laboratories, which makes the brand name version called Mifeprex, joined the Biden administration in asking for the stay.
Danco had told the justices in court filings that, in order to market mifepristone, it would have needed to completely change the drug’s packaging and label and then ask FDA to approve it, typically a monthslong process.
“That would not take place, however, unless the FDA elected to use its enforcement discretion to stop Danco, and the applicants’ papers do not provide any reason to believe the FDA would make that choice,” Alito wrote.
“The FDA has previously invoked enforcement discretion to permit the distribution of mifepristone in a way that the regulations then in force prohibited, and here, the Government has not dispelled legitimate doubts that it would even obey an unfavorable order in these cases, much less that it would choose to take enforcement actions to which it has strong objections,” he continued.
However, federal officials have indicated since the initial decision earlier this month that they were not interested in using enforcement discretion as a way to circumvent a court ruling.
The 5th Circuit has scheduled an oral argument in the government’s appeal for May 17. Access to mifepristone will remain unchanged at least until the three-judge panel issues its ruling, but a party could then again appeal to the Supreme Court.
If they do, the pause will automatically extend until the high court issues its judgment in the case or declines to hear the dispute.
— Updated 7:44 p.m.