As the legal battle over abortion medication mifepristone swells from the left and right, two opposing rulings make the future of the drug's approval even more unclear.
The pill, which has been approved by the FDA for more than 20 years, is at the heart of litigation following the Supreme Court’s historic decision to overturn Roe v. Wade. Its FDA approval is being called into question by states and groups who wish to ban abortion altogether, including by the use of the pill.
On Friday, judges in Washington State and Texas issued separate rulings in mifepristone-related lawsuits. The decisions opposed each other, leaving the question of medical abortion access even more up in the air.
U.S. District Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas ruled to suspend the FDA’s mifepristone approval.
On the same day, U.S. District Judge Thomas O. Rice, a Barack Obama appointee in Washington State, made the opposite ruling by ordering U.S. authorities not to make any changes that would restrict access to the pill in 17 states and Washington D.C.
Kacmaryk concluded that the FDA “exceeded its authority” with the approval as the pill doesn’t provide a “meaningful therapeutic benefit” for patients, he wrote in the 67-page filing. The ruling came in the form of a primary injunction in a lawsuit against the FDA from the Alliance for Hippocratic Medicine, an anti-abortion group that sued the agency in November for allegedly rushing its 2000 mifepristone approval.
President Joe Biden immediately issued a statement pushing back on the ruling, calling it another “unprecedented step in taking away basic freedoms from women” and putting their health at risk.
Legal experts say that the FDA has the authority to decide not to enforce a halt on a drug if it considers it to be safe and effective. If the ruling stands, the agency could issue a determination that it will not enforce the ruling, or it could argue that it won’t be able to stop the drug from reaching patients across the country, according to The New York Times.
Meanwhile, Rice’s ruling later that day came in response to the 17 states that sued the FDA for opposing reasons. The Democratic states want the FDA to lift its additional regulations on the drug, arguing that the agency is “singling out mifepristone” for restrictions that aren’t in place for other drugs. While the judge didn’t move to lift those restrictions, he did order that the FDA not do anything to limit the current access to the drug.
With the conflicting rulings putting the FDA in the middle of the issue, the litigation could go straight to the Supreme Court, NPR reports from legal expert opinion. The unprecedented nature of the injunctions means there shouldn’t be an immediate impact on the drug's access, but it could open the door to other moves to question the FDA’s authority and revoke certain approvals, according to the publication.