Federal Judge Rules FDA Restrictions on Abortion Medication Mifepristone Were Unlawful
A U.S. federal judge in Hawaii ruled today that the Food and Drug Administration (FDA) violated the law by maintaining restrictions on access to mifepristone, a medication used for abortions and miscarriage management.
The ruling stems from a lawsuit brought by the American Civil Liberties Union (ACLU), which argued the FDA’s continued restrictions lack scientific justification. While U.S. District Judge Jill Otake found the FDA’s 2023 decision to maintain requirements like special certification for prescribers and pharmacies, and a mandatory patient counseling form, unlawful under the Administrative Procedure Act, the restrictions remain in place pending further review. The judge instructed the FDA to reconsider evidence it allegedly disregarded when making its decision.
“Today’s decision is a victory for everyone who believes that our access to safe and essential medicines should be dictated by science, not politics,” said Julia Kaye, senior staff attorney with the ACLU Reproductive Freedom Project, in a statement. “Despite decades of real-world experience and mountains of evidence proving mifepristone’s safety, the FDA regulates this medication more heavily than 99 percent of prescription drugs.” The case, dating back to 2017, has navigated multiple administrations and initially challenged an in-person dispensing requirement that was later lifted, allowing the medication to be sent through the mail. Access to medication abortion has become a key battleground in the broader debate over reproductive rights, with potential implications for millions of Americans.
The ruling arrives as mifepristone, approved 25 years ago, faces renewed scrutiny, particularly with growing pressure on current health officials to reevaluate its status. The Justice Department, which previously argued the FDA had already eased restrictions by removing the in-person dispensing requirement, did not immediately respond to requests for comment. Hawaii, a state with a long history of protecting abortion access – becoming the first to legalize the procedure on request in 1970 – currently allows abortion until fetal viability or to save the patient’s life or health. You can learn more about mifepristone from the FDA and find information about the ACLU’s work on reproductive freedom.
The FDA will now be required to address the concerns raised by the court, and it remains to be seen whether the agency will alter its regulations regarding mifepristone.
