Drugmaker Seeks Supreme Court Review of Mifepristone Mail-Order Restriction

A federal appeals court has blocked the mailing of the abortion pill mifepristone nationwide, restoring in-person dispensing requirements that were eased during the COVID-19 pandemic. The ruling by a three-judge panel of the Fifth Circuit Court of Appeals took effect Friday, prohibiting telehealth prescriptions and mail distribution of the drug.

A pharmaceutical company that manufactures mifepristone, Danco Laboratories, filed an emergency appeal to the Supreme Court on Saturday, seeking to stay the decision. The appeals court order halts Food and Drug Administration rules that expanded access to mifepristone, which is used in a majority of U.S. abortions according to data from the Guttmacher Institute.

The court cited concerns over the FDA's handling of safety data, noting that the agency had eliminated requirements to report adverse events before expanding access. Judges stated that the policy undermined state abortion laws, particularly in places like Louisiana where abortion is largely illegal.

The Fifth Circuit's decision requires women to obtain mifepristone prescriptions in person from a medical professional, reinstating protocols from before 2021. The court acknowledged the ruling's nationwide effect, writing that it would restrict distribution systems in use for years.

This follows a lower court order that had temporarily allowed mail access while legal challenges proceeded. Judges criticized the FDA for removing adverse event reporting and then using the lack of data to justify broader access. The ruling sided with pro-life states, stating that federal policy facilitated abortions in defiance of local bans.

For instance, the court noted that every abortion enabled by the policy cancels Louisiana's protections for unborn life from conception.

“It is true, as the district court noted, that a § 705 stay 'would, as a practical matter, have a nationwide effect.'”

Laboratories argued in its Supreme Court application that the appeals court order is unprecedented, as no federal court has previously enjoined a years-old drug approval or reinstated conditions the FDA deemed unnecessary. The company stated that the ruling would cause irreparable harm to patients, providers, and pharmacies reliant on the current system.

Mifepristone was first approved by the FDA in 2000, with mail-order access temporarily allowed in 2021 and made permanent in 2023. The appeal highlighted that the district court had provided time for appeals before its injunction, and the Fifth Circuit had noted preparation time in prior stays.

Pro-life groups welcomed the ruling.

Students for Life President Kristan Hawkins called it a win, stating it prevents abortion-loving states from breaking laws in pro-life neighbors. Family Research Council President Tony Perkins described it as great news for the unborn and predicted a Supreme Court review soon.

Pro-choice advocates opposed the decision. New York Attorney General Letitia James said mifepristone is safe, effective, and essential, labeling the ruling a cruel attack on abortion access. She added that restrictions on abortion care limit life-saving health care.

The case stems from a lawsuit involving a Louisiana woman, Rosalie Markezitch, who alleged her boyfriend coerced her into an abortion using mailed mifepristone from California. Louisiana Attorney General Liz Murrill argued the policy caused irreparable harm by reaching into states with abortion restrictions.

Louisiana classifies mifepristone as a controlled substance and bans most abortions.

The ruling escalates legal battles over abortion drugs following the Supreme Court's 2022 overturning of Roe v. Wade. It pits federal regulators against states enforcing stricter laws. A federal judge, David C. Joseph, had earlier allowed temporary mail access during FDA safety reviews, cautioning against government by lawsuit.

The FDA's ongoing review examines safety data and adverse events. The appeals court order blocks pharmacy dispensing under recent rules, requiring adherence to earlier safety protocols. Mifepristone is typically used with misoprostol for medication abortions.

“This is a win we’ve been waiting for, and we pray it holds." — Students for Life President Kristan Hawkins (Fox News). The Fifth Circuit, covering Louisiana, Mississippi, and Texas, is considered conservative. Two judges were appointed by President Donald Trump, and one by former President George W. Bush. The decision could restrict access even in states where abortion is legal, by ending mail and telehealth options. Sources contradict on the policy's origin: some attribute expansions to the COVID-19 pandemic under federal health responses, while others link them specifically to administrative changes in 2021 and 2023.”