The 5th U.S. Circuit Court of Appeals ruled Aug. 16 that the Food and Drug Administration (FDA) must reinstate safety precautions and restrict distribution for the chemical abortion drug mifepristone.
Under the new ruling, women will only be allowed to use mifepristone in the first seven weeks of pregnancy and will not receive a prescription before an in-person doctor’s visit. The court also prohibited telemedicine prescriptions and mailed shipments of mifepristone.
The order is not effective immediately due to the Supreme Court’s previous decision to allow mifepristone to stay on the market during litigation. It’s expected that the Biden administration will appeal the court’s ruling and the case will head to the Supreme Court.
Last fall, four pro-life medical groups represented by Alliance Defending Freedom sued the FDA for overlooking the safety of women and fast-tracking mifepristone’s approval in 2000.
In 2016, the FDA further pushed to expand the availability of mifepristone by making multiple relaxed changes, including allowing women to use the drugs up to 10 weeks of pregnancy and enabling non-doctors to prescribe the drug. The administration continued to ignore the drug’s potential dangers to women and in 2021removed required in-person medical visits to allow access by mail and telemedicine.
Clinical studies have shown that mifepristone can cause adverse events in women, such as heavy bleeding, infection and incomplete abortion. According to the Charlotte Lozier Institute, “Chemical abortion has a complication rate four times that of surgical abortion, and as many as one out of five women will suffer a complication.”
Since the Dobbs decision, chemical abortions have become increasingly popular, especially for women who live in states where abortion is limited or banned. This means even more women—and preborn babies—are at risk due to mifepristone.
“The 5th Circuit rightly required the FDA to do its job and restore crucial safeguards for women and girls, including ending illegal mail-order abortions,” said Alliance Defending Freedom Senior Counsel Erin Hawley in a statement. “The FDA will finally be made to account for the damage it has caused to the health of countless women and girls and the rule of law by unlawfully removing every meaningful safeguard from the chemical abortion drug regimen.
“The FDA’s unprecedented and unlawful actions did not reflect scientific judgment but rather revealed politically driven decisions to push a dangerous drug regimen without regard to women’s health or the rule of law. This is a significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women.”
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