A federal appeals court on Wednesday appeared unconvinced by Louisiana’s attempt to roll back expanded access to the abortion drug mifepristone, with judges pressing the state over whether it has enough legal grounds to challenge federal prescribing rules.
During arguments before a three-judge panel of the 5th U.S. Circuit Court of Appeals in New Orleans, Louisiana Solicitor General Ben Aguinaga asked the court to invalidate a 2023 Food and Drug Administration rule that permits mifepristone to be prescribed through telemedicine and sent to patients by mail.
Louisiana contends that the policy conflicts with abortion restrictions adopted by the state and other Republican-led states following the U.S. Supreme Court’s 2022 decision overturning the constitutional right to abortion.
Aguinaga argued that mifepristone delivered by mail has contributed to roughly 1,000 abortions a month in Louisiana.
But the judges questioned whether the state could establish that the FDA’s 2023 decision was directly responsible for those abortions.
“There are too many independent actors” involved to conclude that the FDA’s safety determination was causing the abortions, Judge Stephen Higginson said during the hearing.
Judge Dana Douglas also questioned Louisiana’s legal standing, focusing on whether the state could demonstrate a sufficiently direct connection between the federal policy and the harm it claims to have suffered.
Supreme Court intervention looms over case
The case has already made its way through the same appeals court. Earlier this year, another 5th Circuit panel temporarily blocked the FDA’s mail-order rule. The U.S. Supreme Court later lifted that restriction, allowing mifepristone to remain available through telemedicine and mail.
Higginson repeatedly pointed to the Supreme Court’s intervention during Wednesday’s arguments.
The nation’s highest court also unanimously rejected a separate effort in 2024 to restrict access to mifepristone, finding that the challengers in that case lacked standing to bring their claims.
Those earlier decisions could make Louisiana’s latest challenge more difficult.
If the three-judge panel rules against the state, Louisiana could seek review from the full 5th Circuit, where Republican-appointed judges hold a substantial majority, or take the dispute back to the Supreme Court.
Mifepristone remains central to abortion battle
The fight over mifepristone has become a major front in the broader legal battle over abortion access.
Since the Supreme Court’s 2022 ruling, nearly half of U.S. states have enacted abortion bans or stringent restrictions. At the same time, medication abortion has become increasingly common, with the treatment typically involving mifepristone followed by misoprostol.
Data from the Guttmacher Institute indicates that medication abortion now accounts for more than 60% of abortions in the United States.
Louisiana filed its lawsuit against the FDA last year, arguing that the agency failed to properly account for potentially serious complications, including heavy bleeding and infection, when it adopted the 2023 changes and eliminated the requirement that mifepristone be dispensed in person.
A federal judge put the case on hold in April while the Trump administration conducts its own review of the drug’s safety.
FDA review remains unresolved
Justice Department attorney Daniel Winik told the appeals court that the federal review is still underway and that the FDA should be allowed to determine what, if any, regulatory action is warranted.
He said he could not predict what the agency might ultimately decide.
Manufacturers of mifepristone, meanwhile, defended the drug’s safety and argued that the FDA’s 2023 decision was supported by extensive evidence.
The FDA approved mifepristone in 2000, and the agency has repeatedly maintained that the drug is safe and effective. Its periodic evaluations have not identified new safety concerns requiring the restrictions Louisiana is seeking.
The appeals court has not yet indicated when it will issue a ruling.
