A federal judge in Texas on Friday ordered the suspension of the approval of the US abortion drug mifepristone, raising questions about the nation’s access to the nation’s most popular abortion method in a dropped ruling. through decades of scientific approval.
The abortion pill has been widely used in the US since 2000, and there is essentially no precedent for a lone judge to overrule medical decisions by the Food and Drug Administration. Mifepristone is one of two drugs used for medical abortion in the United States, along with misoprostol, used to treat other medical conditions.
U.S. District Judge Matthew J. Kacsmaryk, a Trump administration appointee in Amarillo, Texas, signed an order directing the FDA to continue approving mifepristone while a lawsuit challenges its safety and approval. This medicine is still on. But the immediate impact of the ruling is unclear.
He did not go as far as the plaintiffs wanted by withdrawing or suspending the approval of chemical abortion drugs and removing them from the list of approved drugs. But he has “paused” or halted approval of the drug. However, his ruling did not take effect immediately.
Kacsmaryk gave the government seven days to appeal.
Federal attorneys representing the FDA are expected to quickly appeal.
Mifepristone is part of a two-drug regimen that has long been the standard for medical abortions in US clinics, and doctors who prescribe the combination say they plan to switch to using it alone. misoprostol. The single-drug approach is slightly less effective at terminating a pregnancy.
The lawsuit was filed by the Alliance to Defend Freedom, which is also involved in the Mississippi case that led to Roe v. Wade is overturned. At the heart of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency did not adequately consider its safety risks.
The court has long adjourned to the FDA on issues of drug safety and effectiveness. But the authority faces new challenges in the post-Roe regulatory environment, in which abortion is banned or unavailable in 14 states, while 16 states have laws specifically targeting to the abortion pill.
