The drug, mifepristone, was approved for use by the Food and Drug Administration more than two decades ago. It’s used in combination with a second drug, misoprostol. The 5th U.S. Circuit Court of Appeals in New Orleans ruled Wednesday just before midnight, and the case may now be headed to the U.S. Supreme Court.
By a 2-1 vote, a panel of three judges — from an appellate court known for conservatism — narrowed for now a decision by a lower court judge in Texas that had completely blocked the FDA’s approval of the drug following a lawsuit by mifepristone’s opponents.
The lower court ruling had been on pause for a week to allow an appeal.
Under the appeals court order, the FDA’s initial approval of mifepristone in 2000 is allowed to remain in effect.
But changes made by the FDA since 2016 relaxing the rules for prescribing and dispensing mifepristone would be placed on hold. Those include extending the period of pregnancy when the drug can be used and allowing it to be dispensed by mail without any need to visit a doctor’s office.
The two judges who voted to tighten restrictions, Kurt Engelhardt and Andrew Oldham, are appointees of former President Trump. The third judge, Catharina Haynes, is an appointee of former President George W. Bush. She said she would have temporarily put the lower court ruling on hold entirely to allow oral arguments in the case.
Either side, or both, could take the appeals court’s action to the Supreme Court. Opponents of the drug could seek to keep the full lower court ruling in effect. The Biden administration, meanwhile, could ask the high court to allow all the FDA changes to remain in place while the case continues to play out.
The appeals court judges in the majority noted that the Biden administration and mifepristone’s manufacturer “warn us of significant public consequences” that would result if mifepristone were withdrawn entirely from the market under the lower court ruling. But the judges suggested changes the FDA made making mifepristone easier to obtain since 2016 were less consequential than its initial approval of the drug in 2000. It would be “difficult” to argue the changes were “so critical to the public given that the Nation operated — and mifepristone was administered to millions of women — without them for sixteen years,” the judges wrote.
When the drug was initially approved in 2000 the FDA limited its use to up to seven weeks of pregnancy. It also required three in-person office visits: the first to administer mifepristone; the next to administer the second drug, misoprostol; and the third to address any complications. It also required a doctor’s supervision and a reporting system for any serious consequences associated with the drug.
If the appeals court’s action stands, those would again be the terms under which mifepristone could be dispensed for now.
Democratic leaders in states where abortion remains legal since the Supreme Court overturned Roe vs. Wade last year — including California — say they are preparing in case mifepristone becomes restricted.
New York Gov. Kathy Hochul said Tuesday that her state would stockpile 150,000 doses of misoprostol, the second drug used in two-pill medication abortions.
Pharmaceutical executives this week also signed a letter that condemned the Texas ruling and warned that FDA approval of other drugs could be at risk if U.S. District Judge Matthew Kacsmaryk’s decision stands. There is virtually no precedent for a lone judge overturning the medical recommendations of the FDA.
The lawsuit challenging mifepristone’s approval was brought by the Alliance Defending Freedom, which was also involved in the Mississippi case that led to the Supreme Court’s Dobbs ruling, which overturned Roe vs. Wade. At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency did not adequately review safety risks.
Mifepristone has been used by millions of women for the last 23 years, and complications from its use occur at a lower rate than problems in wisdom teeth removal, colonoscopies and other routine procedures, medical groups have recently noted.