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FDA approval of abortion pill mifepristone in limbo after conflicting rulings

Future access to the most commonly used abortion method in the country was in limbo Friday following conflicting federal court rulings issued minutes apart over the legality of abortion pill mifepristone, which has been FDA-approved for more than two decades.

District Judge Matthew Kacsmaryk, a Trump appointee from Texas, ordered a hold on federal approval of the drug despite decades of approval by scientists and healthcare experts.

Around the same time, District Judge Thomas O. Rice, an Obama appointee from Washington, ordered the opposite — barring authorities from restricting access to mifepristone in at least 17 states where Democrats have sued to protect availability.

In the wake of the dueling rulings, the Associated Press reported that mifepristone appeared to remain at least immediately available. 

Mifepristone is the first of a two-drug regimen that has long been the standard for medication abortion in the US since it was approved by the FDA in 2000. 

The drug is one of two used for medication abortion in the United States, along with misoprostol, which is also used to treat other medical conditions and used as the second drug in the chemical abortion regimen.

There is no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration.

Kacsmaryk signed an injunction directing the FDA to stay mifepristone’s approval while a lawsuit in Texas challenging the safety and approval of the drug continues. The government has seven days to appeal.

“Simply put, FDA stonewalled judicial review — until now,” Kacsmaryk wrote in the 67-page ruling.

Plaintiffs wanted Kacsmaryk to go even further by withdrawing or suspending the abortion medication from the list of approved drugs.

Federal lawyers representing the FDA are expected to swiftly appeal the ruling and the White House is reportedly reviewing the decision.

US Clinics and doctors that prescribe the combination of mifepristone and misoprostol have said they plan to switch to using only misoprostol — slightly less effective at terminating pregnancies — if mifepristone were pulled from the market.

Misoprostol is widely used for abortions in countries where mifepristone is not legal.

The Texas lawsuit was filed by the Alliance Defending Freedom who were involved in the Mississippi case that led to Roe v. Wade’s reversal. The suit alleges that the FDA did not adequately review its safety risks when it approved the drug 23 years ago.

While courts have long deferred to the FDA on issues of drug safety and effectiveness, the agency has found itself in uncharted waters in a post-Roe country in which abortions are banned or unavailable in 14 states, while16 states have laws specifically targeting abortion medications.

Experts do not expect any immediate impact from the conflicting rulings.

“This has never happened before in history — it’s a huge deal,” Greer Donley, a professor specializing in reproductive health care at the University of Pittsburgh Law School, told AP.  “You have a federal judge who has zero scientific background second guessing every scientific decision that the FDA made.”

Last month, top New York officials demanded the nation’s major pharmacy chains reveal their plans about making the abortion pill mifepristone available after Walgreens said it would not distribute abortion pills in some Republican states.

A letter signed by Gov. Kathy Hochul and state Attorney General Letitia James requested Walgreens, CVS Health and Rite Aid show their commitment to dispense mifepristone at pharmacies and via mail in the state.

In February, 20 Republican state attorneys general wrote to Walgreens threatening legal consequences if Walgreens provided mifepristone to consumers in their pharmacies across the country.

With Post wires

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