The abortion pill mifepristone remains 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 Wednesday.
The New Orleans-based Fifth U.S. Circuit Court of Appeals suspended part of last Friday’s order by U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, which had suspended U.S. Food and Drug Administration (FDA) approval for the drug while facing a lawsuit by anti-abortion groups seeking to ban it.
The Biden administration and the maker of the mifepristone brand, Danco Laboratories, had been quick to call for such an emergency stay.
However, the appeals court declined to block parts of Kacsmaryk’s order that effectively reinstated 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 deliver the drug, those restrictions include limiting use to the first seven weeks of pregnancy, down from the current 10.
Kacsmaryk’s order takes effect Friday.
Wednesday’s ruling came from a panel of three Fifth Circuit judges, two nominated by then-President Donald Trump and one by George W. Bush, both Republicans. Judge Catharina Haynes, the Bush appointee, partially disagreed, saying she would have temporarily blocked Kacsmaryk’s order entirely.
The emergency stay is intended to remain in effect until the Fifth Circuit can more fully hear the Biden administration’s appeal to Kacsmaryk’s order. That appeal may be heard by another panel.
The government, anti-abortion groups, or both could also immediately appeal to the U.S. Supreme Court.
The FDA and lawyers for the groups were not immediately available for comment.
Conflicting decisions
Kacsmaryk’s ruling apparently conflicts with another federal judge’s decision, also issued last Friday, that ordered the FDA to keep access to mifepristone without 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 Kacsmaryk’s.
The lawsuit for 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 physicians. They allege the agency used an improper process when it approved mifepristone in 2000 and failed to adequately consider the drug’s safety when used by girls under 18 to terminate a pregnancy.
Both judges’ rulings last week were preliminary orders intended to remain in effect while the lawsuits were pending, and are not final.
However, Kacsmaryk said he thought the anti-abortion groups were likely to succeed on their merits, writing that the FDA “concurred with its legitimate safety concerns — contrary to its legal duty — on the basis of clearly flawed reasoning and studies which did not support her conclusions” when it approved mifepristone.
The majority of the Fifth Circuit said Wednesday that the groups’ challenge to the original 2000 approval was filed too late. However, it said the challenges to the FDA’s subsequent actions, including the 2016 changes and its recent decision to allow mifepristone to be prescribed via telemedicine and delivered by mail, came at the right time.
It said the government’s arguments for an emergency stay of the ruling focused on the potential harm of taking mifepristone completely off the market, but it was “difficult to argue” that the 2016 changes were “so crucial to the public in view of the fact 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 jurisdiction to bring the lawsuit.
“As a result of the FDA’s failure to regulate this powerful drug, these physicians have had to devote significant time and resources to caring for women experiencing the adverse effects of mifepristone,” the majority of the panel wrote.
Hundreds of biotech and pharmaceutical company executives signed an open letter on Monday calling for the reversal of Kacsmaryk’s ruling, saying it undermines FDA authority and ignores decades of scientific evidence about the drug’s safety.
The other ruling, ensuring access to mifepristone, was issued by U.S. District Judge Thomas Rice in Spokane, Washington. It stems from a lawsuit brought by a group of Democratic-led states challenging federal safety restrictions on mifepristone.
Dozens of legal suits have been filed in the two cases, with mainstream medical associations such as 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. are. .
Mifepristone is part of a two-drug regimen, administered in combination with misoprostol, for drug-induced abortion in the first 10 weeks of pregnancy. The drugs are responsible for more than half of all abortions in the country.
Some abortion providers have said that if mifepristone is not available, they would switch to a misoprostol-only regimen for a drug-induced abortion, which is not as effective. It’s not yet clear how widely available it would be.
Some democratically-run states have begun stockpiling the drugs since Kacsmaryk’s ruling.
Abortion has emerged as a powerful political issue in the US since the Supreme Court overturned its landmark 1973 Roe v Wade ruling, which recognized a constitutional right to abortion and left the issue to the states to decide.
Polls show support for abortion rights helped Democrats outperform the November midterm elections, an anti-abortion amendment to the Kansas state constitution failed in August, and Wisconsin voters last week flipped the state Supreme Court to a liberal majority after a campaign centered on abortion.