A federal judge in Texas has issued a temporary stay on the US Food and Drug Administration’s (FDA) approval of mifepristone, one of two pills used for medication abortions. Judge Matthew Kacsmaryk’s decision is expected to have far-reaching impacts on reproductive healthcare across the United States, and it gives the administration of President Joe Biden seven days to appeal before the temporary ban goes into effect. The decision is considered a victory for anti-abortion advocates, as it would render sales of the widely used drug illegal.
Kacsmaryk’s ruling is believed to be the first instance of a single judge overruling the medical authority of the FDA. Shortly after the injunction was announced, a judge in Washington state, Thomas O Rice, issued another ruling that would block “any action to remove mifepristone from the market.” The withdrawal of mifepristone’s FDA approval comes at the request of plaintiffs in a Texas case, a coalition of anti-abortion medical providers called the Alliance for Hippocratic Medicine.
The plaintiffs filed a preliminary injunction to remove mifepristone from the market as they pursue a lawsuit that alleges the FDA was wrong to approve the drug over two decades ago. The case is being heard before a federal court in Amarillo, Texas. The injunction would last for the duration of the case or until a successful appeal. Mifepristone has been available in the US since 2000 and is approved for use in the first 10 weeks of pregnancy, in combination with a second pill, misoprostol. Medical abortion, conducted with pills, is now the most common form of abortion in the country.
The Guttmacher Institute estimates that, in 2020, more than half of all abortions in the US were completed using a combination of mifepristone and misoprostol, an increase from 39 percent in 2017. It is widely considered safe to use. Abortions are possible with misoprostol alone, but that drug regimen is considered not as effective.
Friday’s decision comes less than a year after the Supreme Court overturned Roe v Wade, the landmark 1973 decision that established the constitutional right to abortion. That decision, issued in June 2022, allowed state governments to govern abortion access within their borders, resulting in near-total bans in an estimated 13 states.
Friday’s decision, however, has national implications. In a February statement, the pro-abortion group NARAL wrote, “If FDA approval of mifepristone is revoked, 64.5 million women of reproductive age in the US would lose access to medication abortion care, an exponential increase in harm overnight.” It added, “With a safety record of over 99 percent, medication abortion care is safer than Tylenol.”
The plaintiffs’ overall lawsuit alleges that the FDA failed “to abide by its legal obligations to protect the health, safety and welfare of women and girls” when it approved mifepristone and calls for its removal from the market. Kacsmaryk, an appointee of former Republican President Donald Trump, has yet to rule on the lawsuit.
In his ruling to grant the injunction, Kacsmaryk wrote, “Simply put, FDA stonewalled judicial review – until now.” He cited multiple attempts by the plaintiffs to pull mifepristone off the market. “Before Plaintiffs filed this case, FDA ignored their petitions for over 16 years.”
This is a developing story, and more details are expected to follow.