Danco Laboratories and GenBioPro petitioned the nation's highest court one day after a conservative federal appeals panel froze mail deliveries of mifepristone, the abortion drug used in roughly two-thirds of U.S. abortion procedures. The temporary block, issued by the New Orleans-based Fifth Circuit Court of Appeals on Friday, significantly restricted access to the medication nationwide and particularly in states that have prohibited abortion.
The appeals court ruling marks the first major curtailment of mifepristone access in an ongoing legal battle over the drug's initial approval in 2000 and subsequent regulatory changes. It represents the latest flashpoint in abortion access disputes that have intensified since the Supreme Court overturned Roe v. Wade in 2022, a decision that prompted nearly half of U.S. states to ban or severely restrict abortion.
Danco said the Friday pause "injects immediate confusion and upheaval into highly time-sensitive medical decisions" and forces providers, patients, and pharmacies to operate under unclear guidelines. GenBioPro stated it "firmly believes all people have a right to access safe, affordable, evidence-based healthcare."
Mifepristone is administered as part of a two-drug regimen alongside misoprostol to terminate pregnancies within the first 10 weeks. In 2023, the Food and Drug Administration under former President Joe Biden lifted a requirement that mifepristone be administered in person, citing evidence the drug was safe and effective for remote distribution.
The Fifth Circuit's three-judge panel unanimously concluded that Louisiana, the state behind the legal challenge, was likely to succeed in its lawsuit against the FDA. Louisiana argued the agency ignored potential serious side effects including sepsis and hemorrhaging. Restricting mifepristone access, including through telehealth appointments with out-of-state providers, has been a priority for Louisiana and other Republican-led states with abortion bans.
