Judge halts FDA approval of abortion pill mifepristone

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A federal judge in Texas on Friday ordered a hold on the U.S. approval of the abortion medication mifepristone, throwing into question access to the nation’s most common method of abortion in a ruling that waved aside decades of scientific approval.

The abortion drug has been widely used in the U.S. since 2000 and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration. Mifepristone is one of two drugs used for medication abortion in the United States, along with misoprostol, which is used to treat other medical conditions.

U.S. District Judge Matthew J. Kacsmaryk, a Trump administration appointee in Amarillo, Texas, signed an injunction directing the FDA to stay mifepristone’s approval while a lawsuit challenging the safety and approval of the drug continues. The immediate impact of the ruling was not clear, including how quickly access to the abortion pill might be curtailed.

The judge didn’t go as far as the plaintiffs wanted by withdrawing or suspending the approvals of chemical abortion drugs and removing them from the list of approved drugs. But he put a “stay” or hold on approval of the drug. His ruling, however, doesn’t immediately go into effect, as he gives the federal government seven days to appeal.

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Federal lawyers representing the FDA are expected to swiftly appeal.

Clinics and doctors that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but it is widely used in countries where mifepristone is illegal or unavailable.

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