Judge blocks FDA approval of abortion pill mifepristone

A federal judge in Texas on Friday ordered a stay on US approval of the abortion drug mifepristone, defying decades of scientific approval.

Abortion medication has been widely used in the US since 2000 and there is essentially no precedent for a single judge overruling the Food and Drug Administration’s medical decisions. 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.

In Amarillo, Texas, Trump administration-appointed US District Judge Matthew J. Kaksmarik signed an injunction directing the FDA to halt approval of mifepristone while a lawsuit challenging the drug’s safety and approval continues. But the immediate impact of the ruling was unclear.

Plaintiffs didn’t go as far as they wanted by withdrawing or suspending approval of chemical abortion drugs and removing them from the list of approved drugs. But he put a “stay” or moratorium on the drug’s approval. However, his decision does not come into force immediately.

Kacsmaryk gave the government seven days to appeal.

Federal attorneys representing the FDA are expected to swiftly appeal.

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

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

Courts have long sided with the FDA on issues of drug safety and effectiveness. But the agency’s authority faces new challenges in a post-Roe legal environment in which abortion is banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion drugs.

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