Mifepristone and Abortion Pill Regulation

The Food and Drug Administration approved mifepristone on September 28, 2000, for ending early pregnancies, taken with a second drug, misoprostol. Because of safety concerns it is subject to special restrictions known as a Risk Evaluation and Mitigation Strategy. Over time the FDA extended its use to 10 weeks of pregnancy, and in 2021 and 2023 ended the requirement to pick it up in person, allowing prescriptions by telehealth and dispensing by mail and certified pharmacies. Medication abortion now accounts for nearly two thirds of U.S. abortions.

Abortion opponents challenged the FDA's changes, but in FDA v. Alliance for Hippocratic Medicine in 2024 the Supreme Court unanimously ruled the doctors who sued lacked standing. Several states that support abortion rights passed shield laws protecting doctors who prescribe pills by telehealth to patients in states with bans, and telehealth accounted for about 28 percent of abortions in 2025. States with bans have sued and prosecuted out-of-state prescribers, and some point to the 1873 Comstock Act, which bars mailing abortion drugs and has not been enforced for decades.

In September 2025 the FDA began a new safety review of mifepristone, and it also approved another generic version. Louisiana sued to restore in-person dispensing, and after a federal appeals court ordered that, the Supreme Court blocked the order on May 14, 2026, keeping current rules in place while the case continues. Supporters of the current rules cite decades of studies showing the drug is safe and effective. Opponents argue that removing in-person visits raises risks and undermines state laws.