A federal judge in Texas has temporarily withdrawn approval for the use of mifepristone, one of two pills used for drug-induced abortions, in a ruling that will have major implications for reproductive health care in the United States.
In a victory for anti-abortion advocates, Judge Matthew Kacsmaryk issued a 67-page ruling suspending the U.S. Food and Drug Administration’s (FDA) approval of mifepristone, which would make the sale of the widely used drug illegal.
The decision gives Democratic President Joe Biden’s administration seven days to appeal before the temporary ban takes effect.
Kacsmaryk’s decision is considered the first time a single judge has overruled the FDA’s medical authority. Shortly after the order was announced, a Washington state judge, 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.
They filed a preliminary injunction to remove mifepristone from the market, filing a lawsuit alleging that the FDA was wrong to approve the drug more than two decades ago.
The case is being heard by a federal court in Amarillo, Texas. The order would last for the duration of the case or until a successful appeal.
“Simply put, the FDA has held back judicial review — so far,” Kacsmaryk wrote in his ruling to grant the injunction. He cited multiple attempts by the plaintiffs to withdraw mifepristone from the market. “Before plaintiffs filed this case, the FDA ignored their petitions for more than 16 years.”
Kacsmaryk, an appointee of former Republican President Donald Trump, has yet to rule on the plaintiffs’ overall lawsuit. It alleges that the FDA “failed to comply with its legal obligations to protect the health, safety and well-being of women and girls” when it approved mifepristone and called for the drug to be removed from the market.
The Biden administration has already indicated its willingness to challenge the ruling.
Boarding a plane in Nashville, Tennessee, Vice President Kamala Harris said, “There is no question that the President and I will stand with the women of America and do everything we can to make sure that women have the power to make decisions about their care.”
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 – performed with pills – is now the most common form of abortion in the country.
The Guttmacher Institute estimates that more than half of all abortions in the US were completed with a combination of mifepristone and misoprostol in 2020, up from 39 percent in 2017. It is generally considered safe to use.
Abortions can be performed safely with misoprostol alone, but the single-drug regimen is not considered 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 regulate access to abortion within their borders, resulting in near-total bans in an estimated 13 states and partial bans elsewhere.
However, Friday’s decision has national implications. In a February statement, the pro-abortion group NARAL wrote: “If the FDA approval of mifepristone is withdrawn, 64.5 million women of childbearing age in the U.S. would lose access to abortion care medication, an exponential increase in harm from one day to the next.”
It added, “With a safety record of over 99 percent, drug-induced abortion care is safer than Tylenol.”
Planned Parenthood, a nonprofit reproductive health organization that advocates access to abortion, condemned Kacsmaryk’s decision on Friday as “unprecedented and harmful.”
“Today’s decision to challenge the FDA’s decades-long approval of mifepristone demonstrates just how far anti-abortion activists will go to further restrict abortion across the country,” Planned Parenthood President Alexis McGill Johnson wrote on Twitter.
“We should be furious that the approval of a safe and effective method of abortion can be overruled by ONE judge.”
News of the federal judge’s order also rebounded across the political spectrum as lawmakers weighed in on its implications. For example, Democratic Senator Elizabeth Warren called on the Biden administration to take swift action to appeal the ruling.
“A Trump-appointed judge in Texas thinks he knows better than decades of scientific evidence and ruled to block access to abortion medications nationwide,” she wrote in a Twitter thread. “We cannot allow one right-wing extremist to push aside women, their doctors and the scientists” at the FDA.
Her Democratic counterpart, New York Senator Chuck Schumer, warned the ruling “could plunge our country into chaos.” He called Kacsmaryk an “extremist” and “activist judge”.
Kacsmaryk, appointed in 2019, is seen as a religious conservative sympathetic to right-wing causes. He has ruled that federal programs that provide birth control to minors without parental consent are illegal, and previously removed health care protections for transgender people.
As the sole federal judge in Amarillo for the Northern District of Texas, Kacsmaryk presides over the vast majority of cases filed there — making the city a hot spot for conservative prosecutors seeking a sympathetic verdict, critics say.