A lawsuit filed by anti-abortion groups seeking to ban the use of mifepristone, an abortion pill widely used in the United States, has been heard by a judge in Texas. The Alliance for Defending Freedom and other groups asked Judge Matthew Kacsmaryk to revoke or suspend the drug’s approval, which was granted by the Food and Drug Administration (FDA) more than 20 years ago. If successful, the move would represent an unprecedented challenge to the FDA and would further reshape reproductive rights in the US following the overturning of the landmark 1973 Roe v Wade ruling earlier this year.
Abortion pills are now the most common form of abortion in the US, accounting for over half of all procedures since 2020, according to the Guttmacher Institute. Ahead of Wednesday’s hearing, the abortion rights group NARAL warned that if Kacsmaryk ruled to revoke the FDA’s approval of mifepristone, it would be based on “anti-choice ideology” rather than science or evidence. Since the Supreme Court’s decision to strike down Roe v Wade, numerous Republican-governed states have introduced severe restrictions or outright bans on abortion, with anti-abortion campaigners also targeting abortion pills.
Mifepristone is the first of two pills taken to induce an abortion. The pill stops a pregnancy from proceeding, and a second pill taken up to 48 hours later, misoprostol, causes cramps, bleeding and the emptying of the uterus. The process can be completed safely at home and is approved for up to 10 weeks of pregnancy. The Texas lawsuit alleges that the FDA’s approval of mifepristone in 2000 was flawed for several reasons, including an inadequate review of the pill’s safety risks. The suit also challenges several later FDA decisions that loosened restrictions on the pill, including eliminating a requirement that women pick it up in person.
However, abortion rights advocates have criticised the lawsuit as another attack on reproductive justice in the US. A small group of protesters demonstrated outside the courthouse in Amarillo, Texas, where the case was heard. They carried signs bearing slogans such as “Not your uterus, not your decision” and “Defend medication abortion”. Lindsay London, a 41-year-old nurse, said the case was “100 percent ideologically based”. Major medical organisations, including the American College of Obstetricians and Gynecologists, have supported the FDA’s approval of mifepristone, stating that it “has been thoroughly studied and is conclusively safe”.
Legal experts have also noted that there is little precedent for a lone judge overruling the scientific assessment of the FDA. In a January filing, the FDA stated that halting the sale of mifepristone would “dramatically” harm the public interest and push women to undergo unnecessary surgical abortions. It is not clear when Kacsmaryk will make his decision, but if he rules in favour of the plaintiffs, it is expected that the US government will appeal. If he rules against the FDA, it is unclear how quickly access to mifepristone could be curtailed or how the process would work. The FDA has its own procedures for revoking drug approvals, which involve public hearings and scientific deliberations and can take months or years.