Judge halts FDA approval of abortion pill mifepristone

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Judge halts FDA approval of abortion pill mifepristone
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A federal judge in Texas has thrown into jeopardy the most common method of abortion in the U.S., ordering regulators to temporarily halt their approval of the drug mifepristone for abortion

FILE - Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., March 16, 2022. A federal judge in Texas on Friday, April 7, 2023, 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. Federal lawyers representing the FDA are expected to swiftly appeal the ruling.

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. But the immediate impact of the ruling was unclear. 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.

The lawsuit was filed by the Alliance Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because it did not adequately review its safety risks.

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