The manufacturer of an abortion pill has petitioned the U.S. Supreme Court to examine whether a federal appeals court erred in upholding a preliminary injunction that would curtail mail-order access to the drug.
In a submission made on Friday, Danco Laboratories, the producer of the abortion pill mifepristone, requested the Supreme Court to review a Fifth Circuit Court of Appeals ruling that could potentially limit access to the drug.
Mifepristone received approval from the Food and Drug Administration (FDA) in 2000. The drug is used in the first 10 weeks of pregnancies as part of a chemical abortion procedure to kill unborn children. It is often used in conjunction with another drug, misoprostol, that helps to induce labor to expel the remains. It is also sometimes prescribed for miscarriages.
Danco contends that federal judges should not scrutinize the FDA’s approval of mifepristone or the conditions governing its distribution. Danco is challenging whether courts have the authority to “disregard constitutional and statutory limits on judicial review of executive action in order to overrule an agency decision they dislike.”
In this instance, the Fifth Circuit Court of Appeals, based in New Orleans, issued a decision that impacted the regulations established by the FDA for Mifeprex, the brand name for mifepristone.
Lawyers for Danco assert that the appellate court’s ruling was at the behest of plaintiffs who, in their view, neither “prescribe or use the drug and whose real disagreement with FDA is that they oppose all forms of abortion.”
The federal appellate court’s August ruling would revoke approval for mailing the drug and reduce the window during which mifepristone could be used in pregnancy from 10 weeks to seven weeks.
As a result of this decision, the FDA’s initial 2000 approval of mifepristone remained intact. However, regulatory changes made by the agency in 2016 and 2021, which expanded access to the drug, were reversed.
In April, the Supreme Court intervened in that case, keeping mifepristone broadly accessible, but with more restrictions, while the case plays out. Women will be required to make multiple in-person visits to the doctor before they can obtain the abortion pill.
Justices Clarence Thomas and Samuel Alito, both conservative, publicly dissented from this decision, with Justice Alito writing in a brief opinion that the administration and Danco “are not entitled to a stay because they have not shown that they are likely to suffer irreparable harm in the interim.” No other justices commented.
In their recent filing, Danco’s legal team implored the Supreme Court to review the appellate court’s ruling on the grounds that the case is “of indisputable importance” for women and the drug industry.
The case is the latest development in a legal battle launched in November 2022 challenging the FDA’s approval of mifepristone back in 2000. The Alliance for Hippocratic Medicine and four doctors alleged the approval was flawed and unlawful because it did not adequately review the drug’s safety risks when used by girls under age 18 to terminate a pregnancy.
This case marks the first significant abortion-related disagreement that the Supreme Court will address since it reversed the Roe v. Wade decision last year. That ruling, deemed a win by conservatives, returned the power to make laws about abortions to the states.
Many Republican-led states, in what they commonly frame as efforts to protect women and the unborn, have advanced restrictions on abortions at various stages of pregnancy. Some states, with the strongest pro-life laws, ban abortions at six weeks, when a fetal heartbeat is usually detected.
