DOJ to ask Supreme Court to put abortion pill limits on hold
A federal appeals court ruled that the abortion pill mifepristone can still be used for now but restored restrictions on the drug in a decision that the Justice Department said Thursday it would swiftly challenge at the Supreme Court.
At stake in an accelerating legal battle that began in Texas is nationwide access to the most common method of abortion in the U.S., less than a year after the reversal of Roe v. Wade prompted more than a dozen states to effectively ban abortion outright.
In a ruling late Wednesday, the 5th U.S. Circuit Court of Appeals in New Orleans temporarily narrowed a ruling by a lower court judge in Texas that had completely blocked the Food and Drug Administration’s approval of mifepristone. But a divided three-judge panel still reduced the period of pregnancy when the drug can be taken and said it could not be dispensed by mail.
The ruling preventing the pill from being sent by mail amounts to another significant constraint of abortion access and was cheered by opponents of the drug. The Justice Department said it would ask the U.S. Supreme Court for an emergency order to put any action on hold.
“We are going to continue to fight in the courts, we believe the law is on our side, and we will prevail,” White House Press Secretary Karine Jean-Pierre said Thursday, speaking from Dublin during a visit by President Joe Biden.
Mifepristone was approved by the FDA more than two decades ago and is used in combination with a second drug, misoprostol.
Abortion rights groups expressed relief that the FDA approval would remain in place for now but criticized the court for reinstating restrictions on the drug. Whole Woman's Health, an abortion provider that operates six clinics in five states, said in a tweet it was continuing to offer mifepristone in clinics and through virtual services while reviewing the decision.
In the 2-1 vote, the judges put on hold changes made by the regulator since 2016 that relaxed the rules for prescribing and dispensing mifepristone. Those included extending the period of pregnancy when the drug can be used from seven weeks to 10 and allowing it to be dispensed by mail, without any need to visit a doctor’s office.
The panel's decision came just days after the Justice Department swiftly appealed the far-reaching ruling by a federal judge in Texas that blocked the FDA’s approval of the pill in a lawsuit by the drug's opponents. There is virtually no precedent for a lone judge overturning the regulator's medical decisions.
The lawsuit challenging the drug’s approval was brought by the Alliance Defending Freedom, which also argued for overturning Roe v. Wade and indicated it was content for now in the mifepristone case. Erin Hawley, an attorney for the group, said it had no plans to seek an appeal that might restore the Texas court's full ruling.
“The 5th Circuit’s decision is a significant victory for the doctors we represent, women’s health, and every American who deserves an accountable federal government acting within the bounds of the law,” Hawley said.
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 for now to allow oral arguments in the case.
Adding to the uncertainty, a separate federal judge in Washington last week ordered the FDA not to do anything that might block mifepristone’s availability in 17 Democrat-led states suing to keep it on the market. The judge in that case has not yet to responded to the Justice Department seeking additional clarity this week.
The appeals court judges in the majority in Wednesday's decision 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 FDA changes 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, 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 of 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 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.
The White House also has contingency plans in place, but Jean-Pierre held off detailing them while legal action continued. Instead, she described a proposed new federal rule to limit how law enforcement and state officials collect medical records if they investigate women who flee their home states to seek abortions elsewhere.
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.
At the core of the Texas 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. While less drastic than completely overturning the drug's approval, the latest ruling still represents a stark challenge to the FDA’s authority overseeing how prescription drugs are used in the U.S. The panel overturned multiple decisions made by FDA regulators after years of scientific review.
Common side effects with mifepristone include cramping, bleeding, nausea, headache and diarrhea. In rare cases, women can experience excess bleeding that requires surgery to stop.
Still, in loosening restrictions on mifepristone, FDA regulators cited “exceedingly low rates of serious adverse events.”
More than 5.6 million women in the U.S. had used the drug as of June 2022, according to the FDA. In that period, the agency received 4,200 reports of complications in women, or less than one tenth of 1% of women who took the drug.