By Daniel Wiessner
May 1 (Reuters) – A U.S. appeals court on Friday temporarily blocked a federal rule allowing the abortion drug mifepristone to be dispensed through the mail, significantly curtailing access to the drug nationwide and particularly in states that have banned abortion.
A conservative three-judge panel of the New Orleans-based 5th U.S. Circuit Court of Appeals ruled unanimously that the Republican-led state of Louisiana was likely to prevail in its challenge to the 2023 rule adopted by Democratic former President Joe Biden’s administration.
While the ruling is temporary, it is the first to significantly curtail access to mifepristone in a series of lawsuits challenging the drug’s initial approval in 2000 and subsequent rules making it easier to obtain. The 2023 U.S. Food and Drug Administration regulation removed a requirement that mifepristone be dispensed in person.
The ruling was hailed by Louisiana’s Republican Attorney General, Liz Murrill, who in a statement said she will “look forward to continuing to defend women and babies as this case continues.”
The decision is not the final word on the issue, but is for now the most sweeping threat to abortion access since the Supreme Court rolled back abortion rights in 2022, said Kelly Baden, vice president at the Guttmacher Institute, an abortion rights advocacy group.
“Reimposing medically unnecessary in-person dispensing requirements for mifepristone will send shockwaves of chaos and confusion across the country and dramatically upend patients’ ability to obtain abortion care,” Baden said in a statement.
The FDA did not immediately respond to requests for comment.
SERIES OF LEGAL BATTLES
Restricting access to mifepristone, including through telehealth appointments with out-of-state providers, has been a top priority for Republican-led states that have banned abortion, including Louisiana.
Nearly half of states have banned or severely restricted abortion since the U.S. Supreme Court rolled back its recognition of a woman’s constitutional right to the procedure in 2022. That has driven a surge in medication abortion, which has spurred a series of legal battles over access to the drugs.
Medication abortion is a two-drug regimen consisting of mifepristone, which is used in about two-thirds of U.S. abortions, followed by misoprostol, used to terminate a pregnancy within the first 10 weeks.
In states where abortion is legal and doctors are permitted to prescribe drugs via telehealth, fewer than 2% of prescriptions for abortion drugs are filled in person, according to research from the University of Southern California.
Louisiana sued the FDA last year, claiming the agency in adopting the 2023 rule had ignored the risks of serious adverse events posed by mifepristone, including sepsis and hemorrhaging.
The Biden administration had maintained that mifepristone is effective and safe, citing studies that showed major adverse events occurring in fewer than 1% of patients.
Drug companies GenBioPro and Danco Laboratories have intervened in Louisiana’s lawsuit to defend the FDA regulation. The brand-name version of mifepristone, Mifeprex, is Danco’s only product, and GenBioPro derives most of its revenue from the generic version, the companies said in court filings. The FDA last year approved another generic version made by Evita Solutions.
“We are alarmed by this court’s decision to ignore the FDA’s rigorous science and decades of safe use of mifepristone in a case pursued by extremist abortion opponents,” GenBioPro CEO Evan Masingill said in a statement.
He said the company is committed to taking any actions necessary to make mifepristone as widely available as possible. The drugmakers, as well as the FDA under Trump, could either ask the full 5th Circuit to reconsider the ruling or appeal to the 6-3 conservative majority U.S. Supreme Court.
The Supreme Court in 2024 took up a challenge to the mail-order rule by medical groups and doctors, but ruled that they lacked legal standing to sue. Missouri, Kansas and Idaho have taken over that case, which is pending.
‘PROGRESSIVE RELAXATION’
U.S. District Judge David Joseph in an April 7 decision had paused Louisiana’s lawsuit pending a review by President Donald Trump’s administration of the safety of mifepristone, which, according to media reports, has been delayed until after the November midterm elections.
The judge denied Louisiana’s request to block the 2023 rule but agreed with the state that it was likely unlawful, indicating he would rule that way when the case resumes.
Louisiana had asked the 5th Circuit to pause that ruling and block the rule while the state pursues an appeal, which could take months to resolve.
On Friday, a 5th Circuit panel composed of three judges appointed by Republican presidents agreed with Louisiana that the FDA had failed to justify eliminating the in-person dispensing requirement.
“The agency’s progressive relaxation of mifepristone’s guardrails likely lacked a basis in data and scientific literature,” U.S. Circuit Judge Stuart Kyle Duncan, a Trump appointee, wrote for the court.
He said that “every abortion facilitated by FDA’s action cancels Louisiana’s ban on medical abortions.” Once lost, he wrote, “that sovereign prerogative of protecting unborn life cannot be regained by legal remedy.”
Five other Republican-led states are pursuing two separate lawsuits over FDA abortion drug regulations, including the initial approval 26 years ago. The Trump administration has moved to pause both cases pending its review of the drug.
Louisiana and Texas have also sued or indicted healthcare providers from other states for prescribing mifepristone to their residents, testing so-called shield laws in states including New York and California that protect providers against out-of-state investigations and prosecutions.
(Reporting by Daniel Wiessner in Albany, New York; additional reporting by Nate Raymond and Ahmed Aboulenein; Editing by Mark Porter, Will Dunham, Alexia Garamfalvi and Aurora Ellis)
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