The justices voted to hear the Biden administration’s appeal and reconsider rulings by conservative judges in Texas who disagreed with the Food and Drug Administration’s view that mifepristone is safe and effective and may be dispensed widely.
At issue are FDA regulations in 2016 and 2021 that extended the time for using the pills from seven weeks to 10 weeks of pregnancy and allowed for dispensing the medication without requiring one or more visits to a doctor’s office. Currently the pills may be dispensed through a pharmacy or sent through the mail.
Since the drugs were first approved by the FDA in 2000, they have been used by more than 5 million women in this country and even more around the world, government lawyers said.
The FDA case will be heard in the spring, and it is the most significant abortion case since the court’s conservative majority struck down the constitutional right to abortion in 2022.
If the court were to rule for antiabortion advocates who sued in Texas, it would limit the legal use of abortion medication to seven weeks of a pregnancy and require patients to make one or more visits to a doctor.
In April, the administration won a temporary victory when the justices voted to block the rulings of a west Texas judge and the 5th Circuit Court of Appeals. Justices Clarence Thomas and Samuel A. Alito Jr. dissented.
In her appeal, Solicitor Gen. Elizabeth B. Prelogar argued the antiabortion activists who brought the case in Amarillo, Texas, had no standing to sue, and she said the Texas judges had no basis for overturning the FDA’s regulations.
She said the Texas “decisions mark the first time any court has restricted access to an FDA-approved drug based on disagreement with FDA’s expert judgment about the conditions required to assure that drug’s safe use — much less done so after those conditions had been in effect for years.”
While the district judge in Amarillo would have ordered the drugs to be taken off the market, the 5th Circuit judges agreed it was too late to challenge the FDA’s decisions in 2000 to approve the use of mifepristone. But the 5th Circuit rejected regulatory updates in 2016 and 2021 that allowed for dispensing the drugs through pharmacies and the mail.
She said the courts should not veto “a scientific judgment FDA has maintained across multiple administrations” and impose “unnecessary restrictions on the distribution of a drug that has been used safely by millions of Americans over more than two decades.”
Lawyers for the Alliance Defending Freedom, which sued to halt use of the abortion pills, described the 5th Circuit’s approach as “a modest decision [that] merely restores the common-sense safeguards under which millions of woman have taken chemical abortion drugs.”
If the administration’s rules are upheld, they said, the “national mail-order abortion scheme” would effectively make the procedure available nationwide.