Fifth Circuit Requires In-Person Dispensing of Mifepristone

A federal appeals court ruled on Friday that the abortion pill mifepristone must be dispensed in person, overruling Food and Drug Administration regulations that allowed distribution by mail. The decision by the Fifth Circuit Court of Appeals temporarily reinstates a requirement for in-person pickup, stemming from a lawsuit filed by the state of Louisiana against the FDA's 2023 guidelines that permitted mailing the drug after telemedicine consultations.

The appeals court's ruling agrees with Louisiana's argument that the FDA's mail-order policy undermines the state's abortion ban. " The decision overrides a lower court's earlier order that had paused enforcement of the in-person requirement during an FDA review under the Trump administration.

On Saturday, Danco Laboratories, the manufacturer of mifepristone, filed an emergency application with the Supreme Court to pause the appeals court's ruling. The Supreme Court temporarily restored access to mifepristone via telehealth and mail, according to statements from the court. This interim order allows the FDA's 2023 guidelines to remain in effect while the case proceeds.

The case is likely to return to the Supreme Court for further review. In 2024, the Supreme Court unanimously rejected a separate challenge to mifepristone's approval, two years after overturning Roe v. Wade and ending the nationwide right to abortion.

Mifepristone, approved by the FDA in 2000 for terminating pregnancies up to seven weeks, is the first pill in a two-drug regimen with misoprostol, which is about 95% effective and requires medical follow-up in less than 1% of cases.

The FDA first lifted the in-person dispensing requirement in April 2021 for the duration of the COVID-19 pandemic and made the change permanent in 2023. Between 2000 and 2018, approximately 7 million women in the U.S. used mifepristone. Abortion rates in the U.S. have slightly increased since the overturning of Roe v. Wade, partly due to telehealth access to mifepristone and misoprostol.

" New York Attorney General Letitia James said that "in New York, our laws ensure that anyone who needs abortion care can seek it here," and that access would continue despite the ruling. No immediate comment was provided by the FDA in the available sources as of the ruling date.