Friday, the Supreme Court granted the FDA’s application for a stay, effectively maintaining access to the abortion pill mifepristone as its case goes through the appeals process.
Pictured: Graphic showing two people facing each other outside Supreme Court building / © Nicole Bean
Friday, the Supreme Court granted the FDA’s application for a stay, effectively maintaining access to abortion pill mifepristone as its case goes through the appeals process.
The case will now go back to the Court of Appeals for the Fifth Circuit, which has put the appeal’s schedule on a fast track and is set to hold oral arguments on May 17. Three judges from the appeals court will preside over the upcoming hearing.
New York-based Danco Laboratories, which manufactures mifepristone, also applied for a stay earlier this month.
Support from at least five justices was needed to grant the stay. The court’s brief, ab unsigned order, did not explain why it granted the request by the Biden administration and a manufacturer of the drug to intervene. Justices Clarence Thomas and Samuel Alito publicly dissented; the votes of the other justices were not disclosed.
In the dissenting opinion, Alito wrote that the FDA and Danco have not sufficiently established that they would suffer “irreparable harm” if the stay were not granted.
Alito argued that the Fifth Circuit court’s initial ruling would not have removed mifepristone from the market. Instead, it would have restored “the circumstances that existed” from the pill’s approval in 2000 to 2016, when the FDA adjusted the drug’s label and expanded access to it.
“Congress gave the FDA the authority to determine whether a medicine is safe and effective for patients to use. Allowing the courts to second-guess a decision by the FDA to approve a medicine would create significant uncertainty and harm for manufacturers, patients and physicians,” Jim Stansel, executive vice president, general counsel and corporate secretary, Pharmaceutical Research and Manufacturers of America, said in a statement lauding the Supreme Court’s ruling.
The Legal Tussle Over Mifepristone
The Supreme Court’s ruling addresses a Texas court order made earlier this month, which would have blocked the sale of mifepristone entirely.
District Judge Matthew Kacsmaryk issued a preliminary injunction in favor of the Alliance for Hippocratic Medicine, a November 2022 lawsuit that sought to withdraw the FDA’s approval of mifepristone.
A few days later, the Fifth Circuit Court of Appeals blocked Kacsmaryk’s ruling partially, ordering to uphold the drug’s approval but disallowing the drug’s dispensing through the mail and without a doctor’s sign-off.
The FDA and Danco appealed both decisions, insisting on the safety of mifepristone, as backed by several scientific studies, and warning that if allowed to take effect, the lower court’s orders would “thwart the FDA’s scientific judgment.”
