Access to abortion pill in the US plunged into uncertainty by competing rulings

For now, the drug which was approved by the Food and Drug Administration in 2000 appeared to remain at least immediately available in wake of two separate rulings that were issued just minutes apart by federal judges in Texas and Washington.

US District Judge Matthew Kacsmaryk, a Trump appointee, ordered a hold on federal approval of mifepristone in a decision that overruled decades of scientific approval.

But that decision came at nearly the same time that US District Judge Thomas O Rice, an Obama appointee, essentially ordered the opposite and directed US authorities not to make any changes that would restrict access to the drug in at least 17 states where Democrats sued in an effort to protect availability.

The extraordinary timing of the competing orders revealed the high stakes surrounding the drug nearly a year after the US Supreme Court overturned Roe v Wade and curtailed access to abortion across the country.

“FDA is under one order that says you can do nothing and another that says in seven days I’m going to require you to vacate the approval of mifepristone,” said Glenn Cohen of Harvard Law School.

The abortion drug has been widely used in the US since securing FDA approval 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 also used to treat other medical conditions.

Judge Kacsmaryk signed an injunction directing the FDA to stay mifepristone’s approval while a lawsuit challenging the safety and approval of the drug continues. His 67-page order gave the government seven days to appeal.

“Simply put, FDA stonewalled judicial review — until now,” Judge Kacsmaryk wrote.

He did not go as far as the plaintiffs wanted by withdrawing or suspending approval of the chemical abortion drug and removing it from the list of approved drugs.

Federal lawyers representing the FDA are expected to swiftly appeal. The White House was reviewing the decision.

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 US.

Clinics and doctors that prescribe the combination have said they plan to switch to using only misoprostol. The single-drug approach is slightly less effective at ending pregnancies.

The lawsuit in the Texas case 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.

Democrats and abortion rights groups slammed the ruling out of Texas.

“Abortion is still legal and accessible here in California and we won’t stand by as fundamental freedoms are stripped away,” California Governor Gavin Newsom said.

Legal experts warned that the ruling could upend decades of precedent, setting the stage for political groups to overturn other FDA approvals of controversial drugs and vaccines.