Decision puts on hold part of order by US District Judge Kacsmaryk that suspended FDA approval for abortion pill mifepristone.
The abortion pill mifepristone will remain available in the United States for now but with significant restrictions, including a requirement for in-person doctor visits to obtain the drug, a federal appeals court ruled late on Wednesday.
The New Orleans-based Fifth US Circuit Court of Appeals put on hold part of last Friday’s order by US District Judge Matthew Kacsmaryk in Amarillo, Texas, that had suspended the US Food and Drug Administration (FDA) approval for the drug while he hears a lawsuit by anti-abortion groups seeking to ban it.
The Biden administration and the maker of brand-name mifepristone, Danco Laboratories, had quickly asked for an emergency stay of that order.
However, the appeals court declined to block portions of Kaczmarek’s order that effectively reinstate restrictions on the pill’s distribution that had been lifted since 2016. In addition to a requirement of in-person doctor visits to prescribe and dispense the drug, those restrictions include limiting its use to the first seven weeks of pregnancy, down from the current 10.
Kaczmarek’s order is set to take effect on Friday.
Wednesday’s ruling came from a panel of three Fifth Circuit judges, two appointed by then-President Donald Trump and one by George W Bush, both Republicans. Judge Catharina Haynes, the Bush appointee, partly dissented, saying she would have temporarily blocked Kaczmarek’s order entirely.
The emergency stay is meant to remain in place until the Fifth Circuit can hear the Biden administration’s appeal of Kaczmarek’s order more fully. That appeal may be heard by a different panel.
The administration, the anti-abortion groups or both could also seek to appeal immediately to the US Supreme Court.
The FDA and lawyers for the groups could not immediately be reached for comment.
Kaczmarek’s ruling apparently conflicts with a different federal judge’s decision, also issued last Friday, ordering the FDA to maintain access to mifepristone with no new restrictions in 17 states and the District of Columbia. The Biden administration has asked the judge in that case to clarify his order in light of Kaczmarek’s.
The lawsuit before Kacsmaryk was filed against the FDA in November by four anti-abortion medical associations led by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors. They contend the agency used an improper process when it approved mifepristone in 2000 and did not adequately consider the drug’s safety when used by girls aged under 18 to terminate a pregnancy.
Both judges’ rulings last week were preliminary injunctions meant to remain in effect while the lawsuits are pending, and are not final.
However, Kacsmaryk said he thought the anti-abortion groups were likely to succeed on the merits, writing that the FDA “acquiesced on its legitimate safety concerns – in violation of its statutory duty – based on plainly unsound reasoning and studies that did not support its conclusions” when it approved mifepristone.
The Fifth Circuit majority on Wednesday said that the groups’ challenge to the original 2000 approval had been filed too late. However, it said the challenges to the FDA’s later actions, including the changes in 2016 and its recent decision to allow mifepristone to be prescribed by telemedicine and dispensed by mail, were timely.
It said that the government’s arguments for an emergency stay of the ruling focused on the potential harm of pulling mifepristone from the market entirely but that it was “difficult to argue” that the 2016 changes “were so critical to the public given that the nation operated – and mifepristone was administered to millions of women – without them for sixteen years”.
The court agreed with Kacsmaryk that doctors and groups had standing to bring the lawsuit.
“As a result of FDA’s failure to regulate this potent drug, these doctors have had to devote significant time and resources to caring for women experiencing mifepristone’s harmful effects,” the panel majority wrote.
Hundreds of biotech and pharmaceutical company executives on Monday signed an open letter calling for the reversal of Kaczmarek’s ruling, saying it undermines the FDA’s authority and ignores decades of scientific evidence on the drug’s safety.
The other ruling, ensuring access to mifepristone, was issued by US District Judge Thomas Rice in Spokane, Washington. It arises from a lawsuit brought by a group of Democratic-led states challenging federal safety restrictions for mifepristone.
Dozens of legal briefs have been filed in the two cases, with mainstream medical associations like the American Medical Association and American College of Obstetricians and Gynecologists, abortion rights groups and Democratic politicians supporting the drug’s approval, and anti-abortion groups and Republican politicians opposing it.
Mifepristone is part of a two-drug regimen, administered in combination with misoprostol, for medication abortions in the first 10 weeks of pregnancy. The drugs account for more than half of all abortions in the country.
Some abortion providers have said that if mifepristone is unavailable, they would switch to a misoprostol-only regimen for a medication abortion, which is not as effective. It is not yet clear how widely available it would be.
Some Democratic-led states have begun stockpiling the drugs since Kaczmarek’s ruling.
Abortion has emerged as a potent political issue in the US since the Supreme Court overturned its landmark 1973 Roe v Wade ruling recognising a constitutional right to abortion, leaving the issue for states to decide.
Polls show that support for abortion rights helped Democrats outperform in November’s midterm elections, an anti-abortion amendment to the Kansas state constitution failed in August and Wisconsin voters last week flipped the state’s supreme court to a liberal majority after a campaign that featured abortion.
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