The justice department says it will immediately appeal to the supreme court following an appeals court ruling that the abortion pill mifepristone can remain available in the US but will be subject to significant restrictions.
Late on Wednesday, the fifth circuit court of appeals ruled partially in favour of anti-abortion advocates, imposing restrictions on mifepristone that include lowering the allowable use of the drug to seven weeks of pregnancy instead of the current 10-week limit, and requiring in-person doctor visits for those looking to obtain the drug.
The appeals court decision came after a lower court ruling on Friday last week by judge Matthew Kacsmaryk that suspended FDA authorisation of mifepristone, first granted in 2000, entirely. The appeals court blocked the full suspension, but reinstated restrictions that had been in place before 2016.
Shortly after Kacsmaryk’s decision on Friday, a federal judge based in Washington issued a contradictory ruling, stating that the FDA is not to take any action that would affect the availability of mifepristone. As both courts bind the FDA, the contradictory rulings left the agency with little clear path as to which ruling it should follow.
Adding to the confusion over what the state of play in the coming days will be, the judge in that case issued a further order on Thursday, stating his ruling applies “irrespective” of the fifth circuit court’s decision on Wednesday.
Pro-choice advocates in the US reacted with fury earlier on Thursday at the ruling from the fifth circuit, questioning its scientific basis.
“This decision is a wolf in sheep’s clothing,” said Nancy Northup, president and CEO of the Center for Reproductive Rights. “The appellate court order repeats serious errors in Judge Kascmaryk ruling. It is wrong on the facts and the law, resulting in an unprecedented override of the FDA’s scientific judgment … [that] will wreak havoc on the provision of medication abortion if it stands.”
The appeals court on Wednesday said the plaintiffs bringing the case did not do so quickly enough following the FDA’s original 2000 approval of mifepristone. However, it said the challenges to the FDA’s later actions, including extending its use to 10 weeks and allowing it to be dispensed via telemedicine and the mail, were timely.
The US was already out of step with much of the world in its regulation of mifepristone, one of two drugs commonly prescribed for abortions. It approved mifepristone years after many European countries, and placed far more regulations on the drug than in neighbouring countries such as Canada – including the newly reinstated requirements that it be prescribed in person, and by a doctor.
The ruling could be devastating for millions of women in the US, including those in states where abortion is still legal. Many women do not realise that they are pregnant until two weeks after their missed period – technically at six weeks of pregnancy. Doctors commonly prescribe drugs off-label – meaning they could choose to prescribe it after seven weeks – but it is unclear how many will.
Reinstating the requirement for in-person visits for a prescription will also delay people seeking care, or bump up the likelihood that they will need to have manual procedures for abortions, which will increase strain on abortion clinics.
Wednesday’s ruling came from a panel of three fifth circuit judges, two of whom were appointed by Donald Trump and the other by George W Bush, both Republican presidents. Judge Catharina Haynes, the Bush appointee, partly dissented, saying she would have temporarily blocked Kacsmaryk’s order entirely.
The emergency stay is meant to remain in place until the fifth circuit can hear the Biden administration’s appeal against Kacsmaryk’s order more fully. That appeal may be heard by a different panel.
The anti-abortion group that brought the case, the ultra-conservative Alliance Defending Freedom, has clarified it will not appeal against the portion of the ruling that blocked the suspension of the FDA’s approval of the drug.
“We don’t have any immediate plans to appeal the part of the 2000 approval part of the fifth circuit’s opinion. What the fifth circuit did is really recognize that the FDA actions have been unlawful from the very beginning and [put] a number of requirements back in place to protect women and girls, so we’re happy,” said Erin Hawley, the vice-president of Center for Life & Regulatory Practice, on behalf of the plaintiffs in a press conference on Wednesday.
“For now we have a great victory,” she added.
But legal experts found the nature of the judgment concerning. “The fifth circuit doesn’t consist of scientists. The FDA’s decisions were made after a painstaking review of thousands of pages of scientific evidence by scientific experts,” said Mary Ziegler, a legal historian at UC Davis. “The fifth circuit feels, after I don’t know how many hours of reading filings from the plaintiffs based largely on research from anti-abortion affiliated groups – sometimes people who aren’t scientists at all – that the FDA was mistaken to expand access to mifepristone. That’s concerning.”
Kacsmaryk’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 Kacsmaryk’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 that the agency used an improper process when it approved mifepristone in 2000 and did not adequately consider the drug’s safety when used by under-18s to terminate a pregnancy.
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The reinstated restrictions are temporary while the lawsuits are pending.
However, Kacsmaryk, in the lower court, 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 said the government’s arguments for an emergency stay of the ruling focused on the potential harm of pulling mifepristone from the market entirely, but 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 16 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 Kacsmaryk’s ruling, saying it undermined the FDA’s authority and ignored decades of scientific evidence on the drug’s safety.
Dozens of legal briefs have been filed in the two cases, with mainstream medical associations such as the American Medical Association and the 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 was 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 Kacsmaryk’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, while 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.
