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(NEW YORK) — The abortion pill mifepristone will remain on the market for now — but come Saturday morning, access should be severely restricted, a federal appeals court ruled late Wednesday in partially blocking a lower court order.
It’s a bittersweet victory for abortion rights advocates who feared the conservative 5th Circuit Court of Appeals would side with conservative plaintiffs in the case and force manufacturing and production of the drug mifepristone to stop entirely by Saturday morning. Instead, the three-judge panel is allowing the drug to stay on the market — for now — but with tough restrictions on the drug that haven’t been in place since 2000 when it was first approved and regulators wanted to monitor its safety more closely.
“We are going to continue to fight in the courts. We believe that the law is on our side and we will prevail,” said White House press secretary Karine Jean-Pierre.
Abortion rights opponents said they were pleased with the decision because it paves the way for approval of the drug to be suspended entirely.
“We are very encouraged by this landmark win for women and girls. The Court recognized that the abortion pill is dangerous and rolled back Biden’s reckless mail-order abortion scheme,” said Katie Daniel, the state policy director for Susan B. Anthony Pro-Life America.”
The Justice Department could still take the matter to the U.S. Supreme Court before the appeals court ruling takes effect.
But for now, the drug would be available only up to seven weeks instead of 10 weeks of pregnancy.
Three in-person office visits would be required: the first to administer mifepristone, the second to administer misoprostol — which causes the pregnancy to be expelled — and the third to assess any complications and ensure there were no fetal remains in the womb.
It would require the supervision of a qualified physician and the reporting of all adverse events from the drugs.
Overall, it would roll back every win the abortion rights movement had on this drug in the past two decades.
“The FDA followed decades of science and evidence when it expanded access to mifepristone — a court with no medical experts that has a long history of extremist rulings on abortion has no place taking that away,” said Kirsten Moore, director of the Expanding Medication Abortion Access (EMMAA) Project.
While the appeals court’s decision is temporary while it considers the merits of the case, the panel of judges signaled it was sympathetic to conservative arguments made in the lawsuit, calling the Food and Drug Administration rules around mifepristone “exceedingly unusual” because they allow patients to obtain the drug without seeing a doctor in person.
“Because applicants chose to cut out doctors from the prescription and administration of mifepristone, plaintiff doctors and their associations will necessarily be injured by the consequences. This is an exceedingly unusual regime. In fact, as far as the record before us reveals, FDA has not structured the distribution of any comparable drug in this way,” the panel of appeals court judges wrote.
Danco Labs, which produces the brand name version of the drug Mifeprex, said the FDA’s decisions in recent years to loosen regulation of the drug were based on safety and efficacy data.
“FDA has been empowered by Congress to make decisions about what drugs are safe and effective and how they should be available to patients,” the company wrote in a statement. “Danco remains unchanged in its commitment to do all that we can to support and protect the availability of and access to Mifeprex for healthcare providers and all people in the United States.”
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