US judge suspends approval of mifepristone in latest abortion setback

TEXAS – A United States (US) judge in Texas on Friday suspended the two-decade-old approval of the abortion pill mifepristone while a legal challenge proceeds, dealing another setback to abortion rights in the United States.

Adding to the volatile legal landscape around abortion, a federal judge in Washington state on Friday issued a seemingly conflicting injunction that prevented federal regulators from altering access to the same abortion drug.

The 67-page ruling by US District Judge Matthew Kacsmaryk in Amarillo, Texas, will not take effect for one week, in order to give the Biden administration a chance to file an emergency appeal, which the US Department of Justice said it will do.

Judge Kacsmaryk’s ruling is a preliminary injunction that would essentially ban sales of mifepristone while the case by anti-abortion groups before him continues. The judge, who was appointed to the bench by Republican President Donald Trump, has not yet made a final ruling on the merits of the challenge.

However, in his ruling he found that the lawsuit is substantially likely to succeed. He said that the US Food and Drug Administration had ignored risks in approving the drug.

“The Court does not second-guess FDA’s decision-making lightly,” he wrote. “But here, FDA acquiesced on its legitimate safety concerns – in violation of its statutory duty – based on plainly unsound reasoning and studies that did not support its conclusions.”

The case was brought by four anti-abortion groups headed by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors who sued the FDA in November. They contend the agency used an improper process when it approved mifepristone in 2000 and did not adequately consider the drug’s safety when used by girls under age 18 to terminate a pregnancy.

“By illegally approving dangerous chemical abortion drugs, the FDA put women and girls in harm’s way, and it’s high time the agency is held accountable for its reckless actions,” said Erik Baptist of the Alliance Defending Freedom, which filed the case.

‘Extreme anti-choice agenda’

The ruling will likely inflame the fraught US politics of abortion, which have divided the country since last year’s Supreme Court ruling that overturned a women’s constitutional right to the procedure.

“Democrats will do everything in our power to fight back to ensure access to safe and legal abortion is protected, and voters will hold every last Republican accountable for an extreme anti-choice agenda,” said Jaime Harrison, the chair of the Democratic National Committee.

Since the Supreme Court ruled, 12 of the 50 states now ban abortion outright while many others prohibit it after a certain length of pregnancy, according to the Guttmacher Institute, a research organization that supports abortion rights.

Mifepristone is part of a two-drug regimen, administered in combination with misprostol, for medication abortions in the first 10 weeks of pregnancy. The drugs account for more than half of all abortions in the country.

Some abortion providers have said that if mifepristone is unavailable, they would switch to a misoprostol-only regimen for a medication abortion, which is not as effective. It is not yet clear how widely available it would be.

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