The fate of mifepristone, the abortion drug used widely for over two decades across the United States, may rest in the hands of the U.S. Supreme Court if its members decide to take up requests from the drug’s manufacturer and the Justice Department.
Both Danco Laboratories and the Biden administration have asked the high court to overturn a lower court’s ruling that would limit access to the medication nationwide. That ruling is currently on hold.
If the Supreme Court takes up the case as part of its fall docket, it will mean a decision would likely come down in 2024, with months left before the next presidential election. The court’s decision to ax the nationwide right to abortion by overturning Roe v. Wade last year was widely credited for fueling strong voter turnout in the 2022 midterm elections.
Setting aside evidence of mifepristone’s safety and efficacy, lower federal courts have sided with an ultraconservative coalition challenging the Food and Drug Administration’s decision to approve the drug.
The FDA first cleared mifepristone for use back in 2000 through a lengthy and expert-led approval process; in 2016 and 2021, the agency removed certain barriers to access so that pregnant patients could obtain the drug through a telehealth appointment, if desired. Mifepristone is generally prescribed as part of a two-drug regimen to end a pregnancy; the other drug is misoprostol.
In April, however, a federal judge in Texas sided with abortion opponents who had filed suit against the FDA over its mifepristone approval. U.S. District Judge Matt Kacsmaryk ruled that the agency had “manipulated and misconstrued” the drug approval process to “greenlight elective chemical abortions on a wide scale,” mimicking language used by the anti-abortion activists.
The case was appealed. Based on where it was initially filed, the conservative U.S. Court of Appeals for the 5th Circuit was tasked with reviewing it. A panel of three judges, two of whom were nominated by former President Donald Trump, came down against the FDA — in part.
Supreme Court Justice Samuel Alito authored the controversial opinion that overturned the 1973 Roe v. Wade decision in the court's ruling on Dobbs v. Jackson Women's Health.
Whereas Kacsmaryk thought the FDA’s stamp of approval was wrong from the start, the 5th Circuit thought only that its actions in 2016 and 2021 were wrong, meaning that if their ruling is upheld, access to mifepristone will be rolled back to pre-2016 guidelines.
That would make it harder for pregnant patients to access the pill, requiring them to schedule multiple in-person doctors’ appointments and limiting the window in which the medicine could be prescribed.
Danco is now asking the Supreme Court to weigh in on whether the anti-abortion coalition even had standing to bring its lawsuit and whether the 5th Circuit erred in its judgment. The Justice Department filed a similar petition, with an additional question centering on the district court’s behavior.
While two out of the three 5th Circuit judges on the panel favored rolling back mifepristone access to pre-2016 guidelines, Judge James Ho said he would go further and strip the drug of FDA approval, much as Kacsmaryk called for.
(Ho and Kacsmaryk appeared on a panel discussion hosted by the Federalist Society in Texas this summer.)
Ho, who was sworn in by Supreme Court Justice Clarence Thomas at the home of Republican mega-donor Harlan Crow, claimed that doctors experience “an aesthetic injury” when a patient terminates their pregnancy because “unborn babies are a source of profound joy for those who view them.”