HONOLULU (AP) — The U.S. Food and Drug Administration violated the law by imposing restrictions on access to mifepristone, a drug used for abortions and miscarriage treatment, a federal judge in Hawaii ruled Thursday.
A lawsuit filed by the American Civil Liberties Union argues that the FDA continues to unduly restrict access to a sheltered drug without scientific justification. ACLU lawyers asked the judge to find that the FDA violated the law, but did not seek an immediate repeal of the restrictions, which currently include special certification for prescribers and pharmacies and requiring patients to review a consultation form.
The FDA’s 2023 decision to maintain the restrictions was unlawful under the Administrative Procedure Act “because it did not provide a reasonable explanation for the restrictive treatment of the drug,” said the decision by U.S. District Judge Jill Otake.
Otake’s ruling directs the FDA to review relevant evidence that the agency allegedly ignored. In the meantime, restrictions remain in place.
The decision comes as the pill, used in most abortions in the U.S., remains mired in the politics that have dogged it for nearly a decade, and many wonder whether it will be further restricted under President Donald Trump’s Republican administration. Trump’s top health officials, including Secretary of Health Robert F. Kennedy Jr., are facing increasing pressure from abortion opponents to reevaluate mifepristone, which was approved 25 years ago and has repeatedly been found sheltered and effective by FDA scientists.
The case dates to 2017 and involved both Republican and Democratic administrations.
“Today’s decision is a victory for all who believe that our access to safe and vital medicines should be dictated by science, not politics,” Julia Kaye, senior staff attorney at the ACLU Reproductive Freedom Project, said in a statement. “Despite decades of real-world experience and reams of evidence supporting the safety of mifepristone, the FDA regulates this drug more strictly than 99 percent of prescription drugs.”
When the case began, a key limitation was that patients had to pick up their medications in person at a hospital, clinic or doctor’s office. This restriction was eventually lifted and the pill can be sent by mail. The lawsuit continues to focus on remaining restrictions that the ACLU says disproportionately impact patients who already have difficulty accessing health care, such as those who are low-income or live in rural areas.
Justice Department lawyers involved in the case did not immediately respond to an email from The Associated Press seeking comment on the ruling. They have previously argued that the FDA has already reduced the burden by eliminating the in-person delivery requirement.
Hawaii law allows abortion until a fetus would be viable outside the uterus. According to this, it is legal if a patient’s life or health is in danger. The state legalized abortion in 1970, becoming the first state in the country to allow the procedure at a woman’s request.
