US judge withdraws approval for abortion pill during Texas case

Judge Matthew Kacsmaryk has placed a temporary stay on the FDA approval for mifepristone, used in medication abortions.

A waste bin with empty mifepristone packages
Mifepristone was approved by the US Food and Drug Administration in 2000 and has been on the market for more than 20 years [File: Evelyn Hockstein/Reuters]

A federal judge in Texas has temporarily withdrawn approval for the use of mifepristone, one of two pills used for medication abortions, in a ruling set to have widespread effects on reproductive healthcare across the United States.

In a victory for anti-abortion advocates, Judge Matthew Kacsmaryk issued a 67-page ruling placing a stay on the US Food and Drug Administration’s (FDA) approval of mifepristone, which would render sales of the widely used drug illegal.

The decision gives the administration of Democratic President Joe Biden seven days to appeal before the temporary ban goes into effect.

Kacsmaryk’s decision is considered 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.

They 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 more than 20 years 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.

“Simply put, FDA stonewalled judicial review – until now,” Kacsmaryk wrote in his ruling to grant the injunction. 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.”

Kacsmaryk, an appointee of former Republican President Donald Trump, has yet to rule on the plaintiffs’ overall lawsuit. It alleges 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 the drug’s removal from the market.

The Biden administration has already signalled its willingness to challenge the ruling.

As she boarded a plane in Nashville, Tennessee, Vice President Kamala Harris said: “There is no question that the president and I are going to stand with the women of America and do everything we can to ensure that women have the ability to make decisions about their healthcare.”

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 can be conducted safely with misoprostol alone but the one-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, allows state governments to govern abortion access within their borders, resulting in near-total bans in an estimated 13 states and partial bans elsewhere.

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.”

“With a safety record of over 99 percent, medication abortion care is safer than Tylenol,” it added.

The reproductive healthcare nonprofit Planned Parenthood, a proponent of abortion access, denounced Kacsmaryk’s decision on Friday as “unprecedented and harmful”.

“Today’s decision challenging the FDA’s decades-long approval of mifepristone exposes how far anti-abortion activists will go to further restrict abortion nationwide,” Planned Parenthood president Alexis McGill Johnson wrote on Twitter.

“We should be enraged that approval of a safe and effective abortion method could be overruled by ONE judge.”

News of the federal judge’s injunction also ricocheted across the political spectrum, with legislators weighing in on its implications. Democratic Senator Elizabeth Warren, for instance, called on the Biden administration to take swift action in appealing the ruling.

“One Trump-appointed judge in Texas thinks he knows better than decades of scientific evidence and ruled to block access to medication abortion nationwide,” she wrote in a Twitter thread.

“We can’t let one right-wing extremist overrule women, their doctors, and the scientists” at the FDA.

Her Democratic colleague, New York Senator Chuck Schumer, warned the ruling “could throw our country into chaos”. He called Kacsmaryk an “extremist” and “activist judge”.

Appointed in 2019, Kacsmaryk is seen as a religious conservative sympathetic to right-wing causes. He has ruled that federal programmes that provide contraception to minors without parental consent are unlawful and previously struck down healthcare protections for transgender people.

As the only federal judge in Amarillo for the Northern District of Texas, Kacsmaryk presides over the vast majority of the cases filed there. This makes the city a hot spot for conservative plaintiffs seeking a sympathetic ruling, according to critics.

If Kacsmaryk’s decision on Friday is appealed, the case is expected to go to the 5th Circuit Court of Appeals, which has a conservative majority.

Other lawsuits around the country, meanwhile, are seeking to expand access to mifepristone. Two such lawsuits are under way in West Virginia and North Carolina.

And in February, attorneys general from 12 states, led by Washington and Oregon, filed a lawsuit against the FDA for placing “burdensome” restrictions on mifepristone by including it in the Risk Evaluation and Mitigation Strategies (REMS) programme.

In their lawsuit, the states argue that mifepristone has been used more than 5 million times in the US “with very low rates of complications”.

Already, in January, the FDA loosened REMS restrictions around mifepristone “to reduce burden on the health care delivery system”.

In its guidelines, the FDA warns that medication abortion – like miscarriage and childbirth – can carry a risk of “life-threatening bleeding, infections or other problems”. But it emphasises that mifepristone “is safe when used as indicated”, based on a “thorough and comprehensive review of the scientific evidence”.

Source: Al Jazeera and news agencies