A federal appeals court, in a temporary ruling issued late Wednesday night, allowed a drug company to continue to supply an abortion pill but only under tight restrictions that the federal drug control agency had relaxed over the past seven years.
If the ruling stands, it would mean that women would have to make a decision to use that abortion method before the end of the seventh week of pregnancy; since 2016, they could do so up to the tenth week. That is just one of the practical effects the decision would have. Many women do not even become aware that they are pregnant until the fifth or sixth week, giving them little time to decide on an abortion by the medicine option rather than surgery.
The decision by a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit made it clear that the drug, mifepristone, does not now have to be taken off the market altogether, as ordered by a federal trial judge in Texas last Friday. The appeals panel temporarily relaxed that part of the Texas decision.
Throughout a 42-page opinion, the appeals panel – which divided 2-to-1 – stressed that it was making only a quick ruling after a brief study and said that it planned to move ahead on an expedited schedule to fully decide the controversy. It said it was not taking a final position on any issue at this time.
Wednesday’s ruling left the Food and Drug Administration and the maker of a brand-name version of mifepristone, Danco Laboratories, with the choice of accepting the limited access to the drug allowed by the new decision, or else asking the Supreme Court to put back into place a series of measures making the drug far more widely available and easier to use.
Mifepristone, originally created in France but approved by the FDA in 2000, is the first pill used in combination with another – misoprostol – to bring about the end of a pregnancy in early stages. Some 5 million women in the U.S. have used that combination for abortions, and that method is now used in a majority of cases instead of the more costly and riskier method by surgery.
In practical terms, the new decision would restore a series of restrictions that FDA had imposed on mifepristone when it first found that drug to be safe and effective for abortion, back in 2000. Those limitations include that a pregnant woman would have to make three visits to a hospital, clinic or doctor’s office to get the prescription, take it only under a doctor’s supervision, sign a consent form indicating acceptance of risk and conditions, and inform the doctor of any adverse effects from taking the drug.
Those restrictions only apply to mifepristone, not misoprostol. Some doctors and abortion clinics have indicated that, if mifepristone were not available at all, they could prescribe misoprostol alone that would bring about a pregnancy’s termination, but with more side-effects, including more bleeding.
In the initial ruling last Friday, U.S. District Judge Matthew Kacsmaryk of Amarillo, TX, decided that the FDA’s initial decision 23 years ago to approve mifepristone with all of those restrictions in place was beyond its authority under federal food and drug law and amounted to “arbitrary and capricious” use of its powers. In a separate part of his ruling, the Texas judge also found invalid all of the FDA’s later orders, relaxing many of those restrictions on access. He put his ruling on hold for a week to give the FDA and Danco a chance to take the case on to the Fifth Circuit Court.
The Circuit Court ruled that the challengers to mifepristone – a group of organizations and doctors who are opposed to abortion – had waited too long to challenge FDA’s action in 2000, so it said – at least for now – that this part of their challenge had fallen short.
It went on to rule, again tentatively, that the challengers have a good chance when a final ruling is issued to succeed in striking down what FDA did in 2016, 2019, 2021 and 2023. Among those later actions, FDA allowed women to get access to mifepristone from drugstores rather than from doctors or medical facilities, allowed them to receive it in the mail, and allowed them to take it on their own, at home. The time limit was extended, in one of those actions, from seven weeks of pregnancy to ten.
It appears that those changes would not be allowed, under the Circuit Court’s tentative decision.
In all of its decisions, at any point over the 23 years, FDA has always found that mifepristone was safe and effective, when used under the protocols it specified.
It is unclear whether the Wednesday ruling will allow a second drug company, GenBioPro Inc., to continue to market a generic version of mifepristone. That company gained approval to do so in the 2019 FDA order – one of those now blocked by the Wednesday night ruling.