Federal judge halts FDA approval of abortion pill mifepristone

AUSTIN, Texas — 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. But the immediate impact of the ruling was unclear.

He 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.

Kacsmaryk gave the government seven days to appeal.

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.

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

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.

Courts have long deferred to 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 abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications.