In August 2023, the Fifth Circuit Court affirmed a lower court ruling that the FDA must reinstate restrictions on the mifepristone pill in place before 2016. Those restrictions are currently on hold pending the Supreme Court’s decision. The ruling could also determine up to what point in pregnancy is it legal to take mifepristone.
The FDA first approved mifepristone for abortion in 2000 but included some restrictions on dispensation to prevent severe side effects. One restriction was that the drug had to be prescribed and dispensed in person.
That changed in 2021 when the FDA decided that the in-person requirement put a “burden on the health care delivery system.”
Over the years, other restrictions on the drug have been removed. In 2016, the FDA determined that the drug can be used when a woman is pregnant with a child at 70 days’ gestation. Before 2016, the gestational limit was seven weeks. The FDA also decided in 2016 that non-physicians could prescribe the pill.
After briefs were filed in the Supreme Court this month, Alliance Defending Freedom senior counsel Erin Hawley, whose law firm argued the case in the Fifth Circuit Court, called the Biden administration “reckless.”
“Women and girls should have the ongoing care of a doctor when taking high-risk drugs. But the Biden administration is defending the FDA’s reckless removal of the safety standards it originally deemed necessary for women who use abortion drugs.”