The Biden administration urges the Court to resolve the legal battle over mifepristone, with significant implications for abortion access.
The Biden administration filed a petition with the U.S. Supreme Court on September 8, 2023, asking the Court to end the ongoing legal challenge to mifepristone, a commonly used medication abortion pill. The case concerns a challenge mounted by abortion rights opponents to the FDA’s approval of the drug, which was first authorized in 2000. This appeal could bring a final resolution to the dispute and impact the pill’s availability, including its ability to be prescribed and mailed directly to women seeking medication abortions.
Solicitor General Elizabeth Prelogar, in her filing, emphasized that this case is the first time a court has questioned the FDA’s authority to approve a drug. She argued that lower court rulings against the FDA could lead to severe consequences for mifepristone access, especially the 2021 approval that allowed for its delivery by mail. Prelogar warned that restricting access would harm women seeking abortions, the manufacturers of the drug, and public health.
The Justice Department’s action is supported by Danco, the manufacturer of mifepristone’s brand version, Mifeprex, which also filed an appeal. The Supreme Court’s decision to take the case could come after responses from the challengers, with a decision potentially issued by next summer.
The legal battle began when a group of doctors, supported by the conservative legal group Alliance Defending Freedom, filed a lawsuit claiming that the FDA’s approval process for mifepristone was flawed and that the drug posed unknown risks to women. Despite these claims, the FDA and Danco have argued that serious adverse effects from the drug are exceedingly rare.
In April 2023, the Supreme Court temporarily intervened to block a lower court ruling by Texas U.S. District Judge Matthew Kacsmaryk, who had invalidated the FDA’s original approval of mifepristone. However, conservative justices Clarence Thomas and Samuel Alito expressed support for allowing parts of Kacsmaryk’s decision to take effect.
Following the Supreme Court’s intervention, the case continued to move through the courts, and in August 2023, the 5th U.S. Circuit Court of Appeals upheld part of the decision to impose restrictions on mifepristone, including making it more difficult to access by mail. This has prompted the Biden administration and Danco to seek a final ruling from the Supreme Court.
