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HomeNewsJudge halts FDA approval of abortion pill mifepristone

Judge halts FDA approval of abortion pill mifepristone

By Paul J. Weber and Matthew Perrone | Associated Press

AUSTIN, Texas — A federal judge in Texas on Friday ordered US approval of the abortion drug mifepristone, calling into question access to the country’s most common method of abortion in a ruling that overturned decades of scientific approval.

The abortion drug has been widely used in the US 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 in the United States for medicated abortion, 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 a court order directing the FDA to withdraw approval of mifepristone while a lawsuit over the drug’s safety and approval continues. But the immediate impact of the ruling was unclear.

He did not go as far as prosecutors wanted by withdrawing or suspending the approval of chemical abortion drugs and removing them from the list of approved drugs. But he put a “stay” or wait for the drug to be approved. However, his statement does not take effect immediately.

Kacsmaryk gave the government seven days to appeal.

Federal attorneys representing the FDA are expected to appeal soon.

Clinics and doctors who prescribe the two-drug combination have said that if mifepristone were taken off the market, they would switch to using just the second drug, misoprostol. That single-drug approach has slightly lower effectiveness in terminating pregnancies, but is widely used in countries where mifepristone is illegal or unavailable.

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Mifepristone is part of a two-drug regimen that has long been the standard for drug-induced abortion in U.S. clinics, and doctors who prescribe the combination say they plan to switch to using misoprostol alone. The single-drug approach is slightly less effective at terminating pregnancies.

The lawsuit was brought by the Alliance Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. At the heart of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because it failed to adequately assess its safety risks.

Courts have long delayed the FDA on issues such as drug safety and effectiveness. But the agency’s authority faces new challenges in a post-Roe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications.



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