An appeals court partially overturned a Texas federal judge's preliminary injunction on April 12 by allowing the abortion pill mifepristone to remain on the market, but it cannot be mail ordered. On April 13, the Justice Department appealed this to the Supreme Court.
Two of three appellate judges said the April 7 decision in Texas — which looked to block mifepristone and allowed seven days for an appeal — has some standing, adding that the FDA failed "to regulate this potent drug" and the potential harm "is sufficiently concrete."
The two-drug regimen of medication abortion is safe and 97.4 percent effective, according to the FDA.
"We do not hold that doctors have standing to challenge FDA's actions whenever the doctor sees a patient experiencing complications from an FDA-approved drug," the judges wrote. They said the issue is with mail-order abortion pills, which "cut[s] out doctors from the prescription and administration," leading to "plaintiff doctors and their associations [being] injured by the consequences."
"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 said in a statement.
As the case awaits Supreme Court action, patients will now need the supervision of a qualified physician to obtain the pills.
Mifepristone is more effective than ibuprofen, but the appellate court said other comparisons between the painkiller and the abortion pill are unfounded because mifepristone comes with a "black box" warning of fatal bleeding risks. Prolonged bleeding occurs among 8 percent of those who take medication abortion, and death happens "very rarely," the FDA says.
The judges said the FDA studied the safety consequences of the drug's 2016 allowance for mail-order status "in isolation" but not "as a whole." The 2016 change to mifepristone also extended its approval for the first 10 weeks of pregnancy instead of seven.
Mifepristone will remain available as the appeals court considers more evidence, including a further review of the Comstock Act, an 1873 rule that outlaws "immoral" and "indecent" publications to be mailed. With a similar case unfolding in Washington state, the case of mifepristone's approval and use likely will head to the Supreme Court.
The appeal was expedited to the next available oral argument calendar date.
Read more about the effects of the case here and here.