A federal appeals court ruling has significantly restricted access to mifepristone by blocking its mailing, impacting abortion services across the U.S. The 5th U.S. Circuit Court of Appeals ruled that prescriptions for mifepristone must be distributed in-person at clinics.
This decision reverses the FDA’s 2023 policy that allowed the drug to be sent by mail. In 2000, mifepristone was approved as a safe and effective method for early pregnancy termination. During the COVID-19 pandemic, the FDA temporarily lifted in-person dispensing requirements in 2021, later making this change permanent.
The ruling affects patients’ access to abortion and miscarriage care nationwide. Mifepristone is involved in most abortions in the U.S., and about 1 in 4 abortions are prescribed via telehealth. The conservative-majority Supreme Court previously overturned Roe v. Wade in 2022 but preserved access to mifepristone in 2024.
Legal experts expect an appeal to the U.S. Supreme Court regarding this recent ruling. Danco Laboratories has requested a delay of one week to prepare for the appeal. Judges have historically deferred to FDA judgments on drug safety and regulation.
Key facts:
- Mifepristone was approved in 2000 as a safe and effective way to end early pregnancies.
- The FDA lifted the in-person dispensing requirement for mifepristone during the COVID-19 pandemic in April 2021.
- In 2023, the FDA permanently lifted this requirement, allowing for mail distribution.
- The recent court ruling mandates that mifepristone must be distributed only in-person at clinics.
Judge Kyle Duncan stated that every abortion facilitated by the FDA’s action undermines Louisiana’s ban on medical abortions. Julia Kaye noted that this decision would impact patients’ access to care across all states. Carol Tobias criticized the mail system as prioritizing ideology over safety.
The next steps will involve legal maneuvers as stakeholders respond to the court’s decision. Danco Laboratories’ appeal will be crucial, as it seeks clarity on mifepristone’s distribution moving forward.
