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 three-judge panel of the New Orleans-based 5th U.S. Circuit Court of Appeals ruled unanimously that the 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 FDA and the office of Louisiana’s Republican Attorney General, Liz Murrill, 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.
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 60% 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 companies did not immediately respond to requests for comment.
‘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, the 5th Circuit 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,” Circuit Judge Stuart Kyle Duncan, a Trump appointee, wrote for the court.
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; Editing by Mark Porter, Will Dunham and Alexia Garamfalvi)
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