Appeals Court Limits Mail Delivery of Mifepristone

A three-judge panel of the 5th U.S. Circuit Court of Appeals issued a unanimous ruling on Friday that prohibits the mailing of mifepristone and requires in-person distribution at clinics or hospitals. The decision overrides Food and Drug Administration regulations allowing telemedicine prescriptions and mail delivery of the drug, which is used to end pregnancies up to 70 days gestation.

The ruling, which has nationwide effect, stemmed from a lawsuit filed by Louisiana and other plaintiffs challenging the FDA's 2023 decision to expand access.

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Louisiana argued in its court filings that the FDA's rules facilitated illegal abortions in the state, where abortion is banned at all stages of pregnancy, and resulted in medical complications reimbursed by Medicaid. The state cited FDA data indicating rare cases of excessive bleeding associated with mifepristone use.

The FDA, in statements referenced in the ruling, maintained that over 20 years of data support the drug's safety for remote prescribing, but acknowledged ongoing data collection without a specified end date.

Danco Laboratories, a manufacturer of mifepristone, stated in a filing that the ruling would cause "chaos" for patients and providers, and requested a one-week stay to appeal to the Supreme Court. " Susan B.

The FDA first approved mifepristone in 2000 with requirements for three in-person visits. Restrictions were temporarily eased during the COVID-19 pandemic, and permanently expanded in 2023. The Supreme Court in 2024 preserved access on procedural grounds without ruling on the merits.

No public statements from FDA officials on the appeals court decision were available as of Friday. The ruling does not identify specific numbers of affected prescriptions or complications beyond those cited in Louisiana's filings.

Mifepristone is used in combination with misoprostol for most medication abortions in the U.S., with surveys indicating about 1 in 4 such abortions prescribed via telehealth. In states with abortion bans, some women obtain pills through mail rather than traveling out of state, according to reports cited in the case.

Some states have laws shielding providers who prescribe across state lines. The decision marks an instance where a court overruled FDA judgments on drug safety, an area where courts typically defer to the agency.