Last Updated on May 3, 2026 2:38 pm by BIZNAMA NEWS
HEALTH DESK
Mifepristone manufacturers Danco Laboratories and GenBioPro filed emergency appeals with the U.S. Supreme Court on Saturday, aiming to reinstate mail-order access to the widely used medication. The legal move follows a Friday decision by the 5th U.S. Circuit Court of Appeals that temporarily halted Food and Drug Administration (FDA) regulations allowing the drug to be prescribed via telehealth and delivered by mail.
Danco Laboratories warned that the appellate ruling “injects immediate confusion and upheaval” into time-sensitive medical decisions. Without a stay from the high court, the ruling reinstates a strict in-person distribution requirement, significantly curtailing access for patients nationwide.
Key Developments at a Glance
- Appeals Court Ruling: The 5th Circuit’s decision pauses 2021/2023 FDA rules that expanded access via mail.
- Emergency Filings: Both brand-name and generic manufacturers are asking the Supreme Court for an administrative stay.
- Impact: The ruling forces a return to in-person clinic visits, creating significant hurdles for those in rural areas or states with restrictive laws.
In its filing, GenBioPro said that “patients and clinicians have, for years, relied on dispensing mifepristone without an in-clinic visit, particularly for women from rural areas and those for whom transportation, child care or occupational constraints make it difficult to see providers in person.”