Key facts
- A federal judge in Virginia struck down Biden-era restrictions requiring special licensing for mifepristone.
- The judge ruled the FDA failed to justify the 2023 restrictions after affirming the drug's safety.
- A separate Fifth Circuit ruling requires mifepristone to be distributed in-person, impacting states with abortion bans.
- Makers of mifepristone are seeking emergency relief from the Supreme Court.
A federal judge in Virginia has blocked Biden-era restrictions that required doctors and pharmacies to be specially licensed to prescribe the abortion drug mifepristone, ruling that the administration failed to justify the rule. The decision by U.S. District Judge Robert Ballou struck down the regulation.
Separately, a panel of judges from the U.S. Court of Appeals for the Fifth Circuit issued a nationwide stay of the Biden Administration's 2023 rule, which had removed in-person prescribing and dispensing requirements for mifepristone. This appellate ruling effectively allows mifepristone to be prescribed via telehealth and shipped to patients, but the court's order requires the drug to be distributed only in-person at clinics.
The Fifth Circuit's decision makes it unlawful for doctors outside of Nebraska to prescribe and ship mifepristone into the state. This action was supported by an amicus brief filed by Nebraska Attorney General Mike Hilgers and 21 other states, arguing that the 2023 rule unlawfully overrides state laws protecting unborn life and intrudes on state authority following the Supreme Court's decision in Dobbs.
Both Danco Laboratories and GenBioPro, the two makers of mifepristone, have directly asked the Supreme Court to grant them emergency relief to allow the drug to remain available through telemedicine while the case continues. They argue that the Fifth Circuit's order has created regulatory chaos and restricts access, preventing patients from picking up prescriptions at local pharmacies.