The Justice Department is seeking emergency relief from the U.S. Supreme Court in a Texas case involving limited access to the abortion drug mifepristone.
Late Wednesday, the U.S. Court of Appeals for the Fifth Circuit ruled that mifespristone, which in the U.S. is used in most medication abortions and to treat miscarriages, is approved for use up to seven weeks of pregnancy during the appeals process, but could no longer be dispensed by mail.
This was a dial back from the previous approval of up to 10 weeks and access to the prescribed medication through the mail.
"The Justice Department strongly disagrees with the Fifth Circuit's decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal. We will 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," Attorney General Merrick Garland wrote in a statement announcing the Justice Department's action.
Lawyers for the Biden administration had previously asked the Fifth Circuit Court of Appeals for an emergency stay on a lower court's injunction ruling by U.S. District Judge Matthew Kacsmaryk that was slated to go into effect Friday and would block the Food and Drug Administration's approval of mifepristone.
Department of Justice lawyers argued that "the district court upended decades of reliance by blocking FDA's approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court's own misguided assessment of the drug's safety."
The Supreme Court has not yet indicated if it will take up the case.
The Fifth Circuit's decision drew rebuke from Vice President Kamala Harris on Tuesday. It "second-guesses the agency's medical experts," she said. "If this decision stands, no medication — from chemotherapy drugs, to asthma medicine, to blood pressure pills, to insulin — would be safe from attacks."
Background: How the case got to this point
Since it was first approved by the FDA in September 2000, mifepristone has been used by about 5 million women. The drug has demonstrated strong records of both efficacy and safety: When taken in accordance with agency guidelines, the two-pill regimen successfully ends a pregnancy over 99.6% of the time, and fewer than half a percent of patients experience major complications, according to the NIH.
The original approval allowed mifepristone to be used to end pregnancies through seven weeks. The agency expanded that to 10 weeks and loosened some other safety restrictions in 2016, then approved a generic version in 2019. Amid the COVID-19 pandemic in 2021, the FDA allowed the drug, which is available only by prescription, to be obtained by mail.
Several major medical organizations, including the American Medical Association, say that mifepristone is safe and have urged courts to preserve access.
In November 2022, a coalition of anti-abortion groups and doctors filed a federal lawsuit in Texas district court challenging the FDA's approval of the drug.
The plaintiffs argued that the FDA based its original decision on "transparently false conclusions" about the drug's benefits and risks. Then, they contend that the FDA "failed to satisfy ... rigorous scientific standards" when it later expanded access to the drug.
On April 7, Kacsmaryk sided with the conservative groups and issued a preliminary injunction to vacate the FDA's approval of the drug altogether — a decision with expansive ramifications that legal experts called "unprecedented." In his ruling, Kacsmaryk, a Trump appointee, adopted much of the language of the anti-abortion advocates, including referring to abortion providers as "abortionists" and fetuses as "unborn children."
He stayed his own injunction for seven days to allow an appeals court to weigh in, allowing the drug to remain available in the meantime. The FDA requested an emergency stay of Kacsmaryk's decision, asking the Fifth Circuit Court of Appeals to weigh in by midday Thursday.
Late Wednesday night, just before midnight Eastern Time, the appellate panel issued a complicated ruling on the injunction, siding in part with the FDA and part with the anti-abortion coalition.
It would allow the FDA's original approval of mifepristone to remain in place, the panel said, finding that the statute of limitations to challenge it had likely passed in the 23 years since that approval was first issued.
But the three-judge panel also allowed Kacsmaryk's injunction to remain in effect on the FDA's later actions on mifepristone, including the expansion to 10 weeks of pregnancy and telehealth access — a decision that could greatly diminish access to the drug.
Questions remain about a potentially competing order out of another federal court in Washington
There, a group of Democratic attorneys general from 17 states and the District of Columbia had sued the FDA to expand access to mifepristone.
Earlier this month, Judge Thomas Rice, an Obama appointee, issued his own preliminary injunction, ordering the FDA to preserve status quo access to mifepristone in the jurisdictions represented by the attorneys general — including the telehealth access and approval for use up to 10 weeks of pregnancy.
On Thursday evening, Rice issued an order affirming that for the 17 states and D.C. — the parties in the case before him — access to mifepristone should remain unchanged, regardless of the Texas judge's injunction and the Fifth Circuit's decision. So these cases remain on a collision course.
The Supreme Court's decision could clarify the path forward.
With access to the drug uncertain, some states have stocked up on mifepristone, along with the second drug in the two-pill regimen, misoprostol. Misoprostol is commonly used outside of the U.S. as the sole drug in medication abortions.
