US judge suspends approval of mifepristone

A 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 U.S. Department of Justice said it will do.

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 U.S. 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.

“The Court in this case has substituted its judgment for FDA, the expert agency that approves drugs,” President Joe Biden said in a statement released by the White House late Friday. “If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.”

‘EXTREME ANTI-CHOICE AGENDA’

The ruling will likely inflame the fraught U.S. politics of abortion, which have divided the country since last year’s U.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.

The Biden administration, responding to the lawsuit, had said the drug’s approval was well supported by science, and that the challenge comes much too late.

While conservative states have banned abortion, others have moved to protect access.

Also on Friday, U.S. District Court Judge Thomas Rice in Spokane, Washington, in a separate lawsuit, issued a preliminary order blocking the FDA from making any changes to the current availability of mifepristone. His ruling applied to the 17 states that sued.

Greer Donley, associate professor at the University of Pittsburgh Law School, said there was “definitely a direct conflict” between the Texas and Washington orders, which could bring the case before the U.S. Supreme Court more quickly.

The Justice Department had argued that a ruling in favor of the plaintiffs in Texas would undercut trust in the FDA, the agency that signs off on the safety of food products and drugs, and would increase the burden on surgical abortion clinics already overcrowded with women coming from states that now ban the procedure.

By choosing to sue in Amarillo, the plaintiffs ensured that the case would go before Kacsmaryk, a conservative former Christian activist.

The appeal will go to the New Orleans-based 5th U.S. Circuit Court of Appeals, which has a conservative reputation, with more than two-thirds of its judges appointed by Republican presidents.

The next stop after the 5th Circuit would be the Supreme Court with its 6-3 conservative majority.

Mifepristone is available under the brand name Mifeprex and as a generic. Mifeprex maker Danco Laboratories on Friday filed a notice that it would appeal Kacsmaryk’s decision.

The FDA in January said that the government for the first time will allow mifepristone to be dispensed at retail pharmacies.

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