Published

May 01, 2026

Louisiana: Today, the Fifth Circuit Court of Appeals blocked the Biden Administration’s lax 2023 FDA rule allowing chemical abortion drugs to be dispensed by mail without an in-person physician visit. That rule eliminated critical safeguards designed to protect women from life- or health-threatening complications, including the potentially fatal risk of dispensing the drug to women with undetected ectopic pregnancies, the risk to future fertility posed by undetected Rh-negativity without a Rhogam shot, and the increased risk for advanced gestational age. The revision to the rule was enacted in direct defiance of state pro-life laws protecting unborn life from conception.

“Today’s ruling is an important step toward shutting down the pipeline of illegal mail-order abortion drugs that have circumvented state pro-life laws and endangered unborn lives and the lives, health, and future fertility of women,” said Texas Alliance for Life Executive Director Amy O’Donnell. “The Fifth Circuit Court of Appeals did what the FDA has so far failed to do on its own: uphold states’ rights to protect women and unborn babies from the harms of chemical abortion drugs and protect women in states without pro-life protections from the harms of the drugs dispensed without requiring an in-person physician visit.”

Background

When the FDA approved mifepristone in 2000, the Risk Evaluation and Mitigation Strategy (REMS) required three in-person physician visits and mandatory reporting of serious adverse events. Over time, the FDA progressively dismantled those safeguards. In 2016, the FDA reduced the in-person physician visit requirement from three to one and limited reporting requirements to fatalities only. In 2021, the FDA stopped enforcing the single in-person physician visit requirement, allowing mifepristone to be dispensed by mail.

Following the Supreme Court’s 2022 Dobbs decision returning authority to regulate abortion to the people and their elected representatives, the Biden Administration issued an executive order directing federal agencies to expand access to the chemical abortion drug regimen. The following year, the FDA formally codified that 2021 directive into the revised 2023 REMS, cementing mail-order abortion drug dispensing without any in-person physician visit requirement.

In 2025, the State of Louisiana challenged the 2023 REMS under the Administrative Procedure Act, arguing that the FDA’s justifications for remote dispensing were based on flawed or nonexistent data. The FDA conceded it had failed to adequately study whether remotely prescribing mifepristone is safe and launched a comprehensive review in September 2025. As of May 2026, that review remains incomplete with no projected timeline for completion.

The Fifth Circuit Court found that Louisiana is substantially likely to succeed on the merits of its challenge and that the public interest favors a stay. The court found it unreasonable that the FDA eliminated its own adverse-event reporting requirement for mifepristone and then cited the absence of reported complications as justification for loosening safety standards. The FDA’s own black box label for mifepristone acknowledges that 2.9 to 4.6 percent of women who take chemical abortion drugs will experience serious complications requiring medical intervention.

The court further found that the 2023 REMS caused concrete harm to both Louisiana’s sovereign interest in enforcing its pro-life laws and real financial harm through the state’s Medicaid costs for women who experience life- or health-threatening complications following mail-order abortions.

Texas Alliance for Life will continue to monitor this case while advocating for the full enforcement of our laws that protect unborn children from the moment of conception and their mothers from the harms of illegally trafficked chemical abortion drugs.

Contact: 

Ashley Sosa

Director of Communications

Ashley@texasallianceforlife.org

512-477-1244

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