A federal appeals court on Wednesday night blocked part of a ruling issued last week by a Trump-appointed judge that jeopardized access to the abortion pill mifepristone.
The US Court of Appeals for the Fifth Circuit granted the Justice Department’s emergency request to stay the part of the decision issued by US District Judge Matthew Kacsmaryk that stayed the original approval of mifepristone by the Food and Drug Administration (FDA), dating back to 2000.
But the three-judge panel said a separate part of Kacsmaryk’s decision, which suspends changes the FDA made to the drug’s approved use in 2016, could take effect. The panel also determined that the agency’s 2021 finding that mifepristone can be distributed by mail would also be stopped, as ordered by Kacsmaryk.
The court’s decision jeopardizes the drug’s widespread availability, as it would require patients to make in-person visits to obtain it.
The 2016 changes, among other things, reduced the number of in-person visits patients must make from three to one.
The appeals court said it would expedite full consideration of the case.
The Justice Department may still ask the Supreme Court to intervene in an attempt to block Kacsmaryk’s ruling entirely. The administration would need to win the votes of at least five of the nine justices on the court, which has a 6-3 conservative majority.
The panel was split 2-1, with Justice Kurt Engelhardt and Justice Andrew Oldham, both appointees of former President Donald Trump, in the majority. Judge Catharina Haynes, a President George W. Bush appointee, said she would have temporarily blocked the ruling in its entirety.
The Biden Administration and Danco Laboratories, the maker of Mifeprex, the brand-name version of mifepristone, filed motions to stay Kacsmaryk’s ruling.
Kacsmaryk’s decision “upended decades of dependency by blocking FDA approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own flawed assessment of the drug’s safety.” ”the Justice Department lawyers wrote in court documents.
The anti-abortion coalition that challenged the FDA’s approval of the drug in 2000, called the Hippocratic Medicine Alliance, waited too long to file its lawsuit and has no legal standing to do so, the lawyers wrote.
Danco’s lawyers said Kacsmaryk’s ruling adopted a «one-sided narrative» that «omits crucial facts,» including the benefits of the drug for millions of women.
Challengers to the drug’s approval said in court documents that a decision in favor of the federal government would «perpetuate the FDA’s illegal abortion-by-mail regimen and cause further damages for a dangerous drug that the district court found should never have been approved.» «.
If Friday’s ruling takes effect in its entirety, it would suspend the Food and Drug Administration’s approval of mifepristone, the first of a two-drug regimen used to perform medical abortions. acronym in English). That would jeopardize access to mifepristone across the country. However, Kacsmaryk gave the federal government a week to appeal his decision before it went into effect.
“If allowed to go into effect, the court order would frustrate the FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity,” the Justice Department attorneys wrote. in the most recent submission. “This damage would be felt throughout the country, since mifepristone has licit uses in all states. The order would undermine health care systems and the trustworthy interests of companies and medical providers.»
To further complicate matters, a federal judge in Washington state issued a preliminary injunction in a different case on Friday that prohibited the FDA from «disturbing the status quo and rights regarding the availability of mifepristone.»
That ruling applies only to the 17 liberal-leaning states and the District of Columbia that filed a lawsuit in February challenging FDA regulations on the drug. The Justice Department filed a motion in federal district court in Washington state, seeking clarification on Friday’s ruling.
The dueling decisions in Texas and Washington could mean that the Supreme Court, which last summer struck down the landmark Roe v. Wade, you may soon be able to address the matter in an expedited manner.
Kacsmaryk’s ruling, if upheld, would not mean that access to mifepristone would be immediately cut off across the country. Instead, anyone involved in manufacturing, distributing or prescribing would face legal risk, said Greer Donley, a professor at the University of Pittsburgh School of Law who specializes in reproductive rights.
The FDA could help alleviate that risk by announcing that it will not take enforcement action against anyone involved in distributing the drug, he added. The agency has broad power to do so, and the Supreme Court in a 1985 ruling said such decisions generally cannot be challenged in court.
Although misoprostol can be used alone for abortions, experts have said that it is not as effective in terminating pregnancies as it is in combination with mifepristone.
Most abortions in the US are performed with the use of pills, according to a survey by the Guttmacher Institutea research group that supports abortion rights.