In a mixed ruling, an appeals court blocked Biden administration regulations making the abortion pill easier to access.
The regulations include a 2021 rule - part of the awful legacy of COVID - allowing patients to get abortion pills in the mail.
It's the latest development in a high-profile legal dispute over the controversial drug mifepristone, used to induce more than half of abortions in the nation.
A panel of the Fifth Circuit appeals court declined to touch the original FDA approval in 2000, but found the agency went too far under Biden when it loosened restrictions on the drug.
The court blocked regulations allowing the drug to be ordered through the mail and prescribed by someone other than a doctor, as well as a 2016 rule expanding the window for the pill's use from seven to 10 weeks.
The panel consisted of Jennifer Walker Elrod, a George W. Bush appointee, and Trump appointees James Ho and Cory Wilson.
"In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” Elrod wrote.
In a concurring opinion, Judge Ho went further and argued the FDA's original authorization was unlawful also.
The FDA used a regulation called Subpart H, which allows expedited approval of drugs to treat "serious or life-threatening" illnesses.
Echoing U.S. District Judge Matthew Kacsmaryk, who blocked the pill completely in April, Judge Ho noted that pregnancy is not a disease.
"The FDA approved mifepristone under its Subpart H regulations. But Subpart H only authorizes the FDA to approve drugs that ‘treat serious or life-threatening illnesses.’ And pregnancy is plainly not an illness,” Ho wrote. “So it was unlawful for the FDA to approve mifepristone under Subpart H.”
The court's ruling is paused until the Supreme Court decides whether to take up the case. The Supreme Court previously ruled to preserve access to the pill until litigation is resolved.
The pro-life movement says the abortion pill was authorized unlawfully and without proper consideration of its health risks, but Democrats have blasted restrictions on the pill as an attack on women's rights, "science" and the expertise of FDA bureaucrats.
"If the Fifth Circuit's ruling stands, it will significantly roll back the ability for women in every state to get the health care they need, and undermine FDA's scientific, evidence-based process for approving safe and effective medications that patients rely on," Biden press secretary Karine Jean-Pierre said.
