A federal appeals court has preserved access to an abortion drug for now but under tighter rules that would allow the drug only to be dispensed up to seven weeks, not 10, and not by mail.
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.
By a 2-1 vote, a panel of three judges narrowed for now a decision by a lower court judge in Texas Friday 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 also 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 both appointees of former President Donald Trump. The third judge, Catharina Haynes, is an appointee of former President George W. Bush. She said she would have put the lower court ruling on hold entirely temporarily to allow oral arguments in the case.
The decision could still be appealed to the U.S. Supreme Court. In the meantime, Democratic leaders in states where abortion remains legal since the Supreme Court overturned Roe v. Wade last year 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, another drug used in medication abortions.
Further complicating the legal landscape is a separate decision from a federal district judge in Washington, also issued Friday, that blocked the FDA from altering the status quo regarding to mifepristone’s availability in 16 states and the District of Columbia. Those states and D.C. sued the Biden administration in February over a set of restrictions imposed on the drug and sought to preserve access to it.
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 Roe v. Wade being overturned. 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 over the past 23 years, and complications from mifepristone occur at a lower rate than problems in wisdom teeth removal, colonoscopies and other routine procedures, medical groups have recently noted.
The FDA made several changes to the rules surrounding the abortion pill since its initial green light, including approving a generic version of mifepristone in 2019 and lifting a requirement that the pills be dispensed in-person in 2021, allowing the drug to be prescribed by a provider during telemedicine appointments and sent by mail.
Medication abortions accounted for more than half of the abortions in the U.S. in 2020, according to the Centers for Disease Control and Prevention, and the Biden administration told the 5th Circuit that serious adverse events are rare when mifepristone is used as directed by the FDA. More than 5 million women have take mifepristone since 2000, and only 28 deaths were reported through June 2022, though some were associated were “obvious alternative causes” unrelated to use of the abortion pill, according to the FDA.
“The court upended the status quo with its abrupt and sweeping nationwide order,” the Biden administration said in seeking a stay of Kacsmaryk’s ruling. “If allowed to take effect, that order will irreparably harm patients, healthcare systems, and businesses.”
