(CNN) A federal appeals court on Wednesday night froze parts of a Texas judge’s order that suspended the US Food and Drug Administration’s approval of an abortion drug.
But the court only partially granted the request of the Justice Department and the drug manufacturer to prevent US District Judge Matthew Kacsmaryk’s ruling, with the panel effective in making the drug more difficult to obtain.
On Friday, Kacsmaryk issued a ruling that would halt the 23-year-old FDA approval of the drug, mifepristone. Under the appeals court’s new order, the approval will remain in effect and the drug will remain on the market while an expedited appeal plays out.
However, the US 5th Circuit Court of Appeals left parts of the decision that halted changes made by the FDA to the rules surrounding the drug that expanded access to medication abortion pills. Those changes include the FDA’s end of the requirement that mifepristone be taken personally, the agency’s approval of a generic version of the drug, and changes the FDA made to the label instructions for use. of medicine.
Medication abortion, which makes up the majority of abortions obtained in the United States, has emerged as a hot flashpoint in the abortion legal battle since the Supreme Court overturned last year’s Roe v. Wade precedent protecting abortion rights in the country.
In issuing his ruling last week, Kacsmaryk delayed its effective date for seven days to give the government time to appeal.
It is unclear whether the Justice Department or the drug’s manufacturer, Danco Laboratories, will ask the Supreme Court to intervene at this point. Earlier this week, the DOJ indicated it would appeal to the high court if the 5th Circuit did not act by noon CT on Thursday.
In November, anti-abortion doctors and plaintiffs brought a lawsuit challenging the FDA’s 2000 approval of the drug and pointing out how the agency changed its rules of use in ways that made it easier to take the pill.
A split 5th Circuit panel said in its new order that it reinstated the drug’s approval because of some procedural hurdles plaintiffs faced in challenging it. But the appeals court said the abortion pill’s defenders had not shown they were likely to succeed in defeating the plaintiffs’ claims against the FDA’s latest regulatory actions regarding mifepristone.
The appeal order was handed down by Circuit Judges Catharina Haynes, a George W. Bush nominee, and Kurt Engelhardt and Andrew Oldham, both nominees of Donald Trump. Haynes, however, did not sign certain aspects of the order.
The judge said he would grant the expedited appeal but would issue an administrative stay of Kacmsaryk’s sentence — a temporary hold lasting a “short period of time” — and deferred the question is whether it should be frozen longer term. to the judges hearing the expedited appeal.
That panel is different from the panel that considered the request of the DOJ and Danco to suspend the ruling for the time being.
Much of the 5th Circuit’s 42-page order was devoted to analyzing whether the plaintiffs faced procedural issues in bringing their case. The appeals court was largely sympathetic to the plaintiffs’ allegations about the drug’s safety, which have been criticized by leading medical associations.
The 5th Circuit said that the FDA’s current rules around the drug made for “an unusual regime” because the agency “chose to cut doctors off from prescribing and administering mifepristone.”
“In fact, as far as has been revealed before us, the FDA has not structured the distribution of any similar drug in this way,” the panel said.
The FDA approved mifepristone after a four-year review process. It has been shown to be a safe and effective way to end a pregnancy in the two plus decades it has been on the market. But anti-abortion doctors and medical associations say the agency violated the law by not paying enough attention to the drug’s perceived risks.
This story has been updated with additional details.