Danco Laboratories has turned to the U.S. Supreme Court in an urgent bid to block a lower court ruling that could immediately disrupt how the abortion pill mifepristone is distributed across the country.
The filing, submitted Saturday, asks the nation’s highest court to stay a decision from the U.S. Court of Appeals for the Fifth Circuit. That decision, issued late Friday, effectively rolled back FDA rules from 2023 that allowed the medication to be prescribed via telemedicine and sent through the mail.
At the heart of the legal tug-of-war is the question of “standing”—whether the state of Louisiana has the legal right to challenge the FDA’s safety regulations. Danco argues that the Supreme Court already settled this issue just last year in a unanimous decision.
In that prior case, FDA v. Alliance for Hippocratic Medicine, the Supreme Court ruled that doctors who do not prescribe the drug cannot sue the FDA just because they might one day have to treat a patient facing complications.
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Danco’s lawyers argue that Louisiana’s claims are even more “attenuated,” based on roughly $92,000 the state says its Medicaid program paid for emergency care for two women who used the drug.
Danco contends that if states could sue over “downstream economic injuries” like these, they could challenge almost any federal health policy. “The chain of causation is simply too attenuated,” the company wrote, quoting the Supreme Court’s own language from 2024.
The Fifth Circuit’s ruling has created a direct conflict with the Ninth Circuit Court of Appeals, which recently rejected nearly identical arguments from the state of Idaho. Danco warns that this legal split, combined with the suddenness of the Fifth Circuit’s order, creates “immediate confusion and upheaval.”
The company highlighted several practical dilemmas caused by the sudden change:
- Pharmacy Stock: It remains unclear what pharmacies should do with current medication supplies.
- Patient Care: Women with appointments scheduled as early as this weekend are now in “limbo.”
- Regulatory Conflict: The FDA is currently in the middle of its own court-ordered review of the drug’s safety protocols.
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Danco, a small pharmaceutical firm for which Mifeprex is its only product, stated that losing the ability to distribute the drug under current rules threatens the very existence of its business.
Danco is requesting an “administrative stay,” which would act as a temporary freeze on the Fifth Circuit’s order while the Supreme Court fully considers the case. If the Court does not act, the 2023 rules would be suspended, reverting the drug to a more restrictive distribution model that requires in-person doctor visits.
The company has asked the Court to treat the application with extreme urgency, suggesting the case could even be set for expedited briefing and argument before the court’s summer recess. For now, providers and patients across the U.S. are waiting to see if the Supreme Court will step in to maintain the status quo.
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