By Daniel Wiessner
May 14 (Reuters) – The U.S. Supreme Court has for now refused to block a U.S. Food and Drug Administration rule allowing the abortion pill mifepristone to be prescribed via a telehealth appointment and dispensed through the mail, preserving access to a drug used in more than 60% of U.S. abortions.
WHAT IS MIFEPRISTONE?
Mifepristone, first approved by the FDA in 2000 under the brand name Mifeprex, blocks the effects of the hormone progesterone, which is essential for maintaining a pregnancy. It is generally taken as part of a two-drug regimen with misoprostol, which aids in emptying the uterus. The FDA initially approved mifepristone in 2000 for use in the first seven weeks of pregnancy, and raised that to 10 weeks in 2016.
WHAT DOES THE FDA RULE DO?
Adopted during the administration of former President Joe Biden, a Democrat, the 2023 rule removed a prior requirement that mifepristone be prescribed and dispensed in person. That allows the drug to be prescribed via telehealth appointments and distributed through the mail. The FDA in 2023 also established strict requirements for retail pharmacies to sell mifepristone.
WHAT HAPPENS NEXT IN THE CASE?
The Supreme Court’s decision stems from a 2025 lawsuit by Louisiana, which argued that the FDA rule was unlawful and has allowed medication abortions to skyrocket despite the state’s near-total ban on abortion.
The Republican-led state is appealing a federal judge’s decision to stay the lawsuit until a new FDA review of the safety of mifepristone is complete. That review has been delayed until after the November midterm elections, according to media reports.
The appeal is pending at the New Orleans-based 5th U.S. Circuit Court of Appeals, which is widely considered the most conservative federal appeals court. The 2023 rule will remain in effect until that appeal is decided or the case returns to the Supreme Court on further appeal.
ARE THERE OTHER CHALLENGES TO MIFEPRISTONE ACCESS?
Two other pending lawsuits by five Republican-led states have the potential to curb access to abortion drugs even more drastically, including by cutting it off altogether.
In December, Texas and Florida filed a lawsuit targeting the FDA’s initial approval of mifepristone in 2000 and several subsequent approvals and regulations that eased access, including the mail-order access rule. And separately, Missouri, Kansas and Idaho are arguing that the FDA acted improperly when it eased restrictions on mifepristone in 2016.
As it did in Louisiana’s case, the Trump administration has asked judges to pause both of those lawsuits pending the FDA review of mifepristone. Texas and Florida have agreed to a pause but drugmakers GenBioPro and Danco Laboratories, which intervened in the case to defend the FDA regulations, oppose it.
ARE THERE ANY LAWSUITS SEEKING TO EXPAND ACCESS?
Physicians and medical groups are challenging FDA rules also adopted in 2023 requiring providers and pharmacies to be certified to prescribe and dispense mifepristone and to obtain a signed authorization from patients. They claim the restrictions are unwarranted because mifepristone is safe and effective.
A federal judge in Hawaii ruled last year that the FDA had failed to explain why the dispensing requirements were necessary and directed the agency to reconsider them, but said the rules would remain in place in the meantime. A judge in Virginia is expected to rule soon in a similar case, which the FDA is seeking to pause pending its review.
Separately, challenges are pending to laws in West Virginia, North Carolina and Louisiana that limit access to mifepristone despite its approval on the federal level.
HOW COULD STATES THAT BAN OR RESTRICT ABORTION RESPOND?
If courts preserve access to mifepristone, more states could move to limit it by prosecuting out-of-state doctors who prescribe it within their borders. In an unprecedented interstate conflict, a New York state judge in October rejected a bid by the Texas attorney general’s office to order a New York county to enforce a $100,000 judgment against a doctor for sending abortion pills to Texas, which has appealed the ruling.
The case will test New York’s so-called shield law precluding the enforcement of other states’ abortion bans against New Yorkers. About 20 other states have similar laws.
Texas and Louisiana also passed laws in 2025 allowing private citizens to sue anyone who mails or distributes abortion medication to or from the state. A California doctor who was the first person sued under Texas’ law has asked a federal judge to rule that it is unconstitutional.
(Reporting by Daniel Wiessner in Albany, New York, Editing by Alexia Garamfalvi and Sanjeev Miglani)
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