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HONOLULU (AP) – The U.S. Food and Drug Administration violated the law by imposing restrictions on access to the abortion and miscarriage drug mifepristone, a federal judge in Hawaii ruled Thursday.
The lawsuit by the American Civil Liberties Union alleges that the FDA continues to unduly restrict access to safe medicines without a scientific basis. ACLU lawyers asked the judge to find that the FDA violated the law, but they are not currently asking for an immediate lifting of restrictions, such as special certifications for prescribers and pharmacies or requirements to review counseling forms for patients.
The ruling by U.S. District Judge Jill Otake said the FDA's 2023 decision to keep the restrictions in place was illegal under the Administrative Procedure Act “by failing to provide a reasonable explanation for the restrictive treatment of the drug.”
Otake's ruling directs the FDA to consider relevant evidence that the agency allegedly ignored. In the meantime, restrictions remain in place.
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The decision comes as the pill, which is used in most abortions in the United States, has been embroiled in politics for nearly a decade, with many wondering whether it will be further restricted under President Donald Trump's Republican administration. Top health officials in the Trump administration, including Health Secretary Robert F. Kennedy Jr., are facing growing pressure from abortion opponents to reevaluate mifepristone, which was approved 25 years ago and repeatedly found safe and effective by FDA scientists.
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The case dates back to 2017 and spanned both Republican and Democratic administrations.
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“Today's decision is a victory for everyone who believes that access to safe and essential medicines should be determined by science, not politics,” Julia Kay, senior staff attorney at the ACLU Reproductive Freedom Project, said in a statement. “Despite decades of practical experience and mountains of evidence proving mifepristone's safety, the FDA regulates this drug more tightly than 99 percent of prescription drugs.”
When this incident first began, key restrictions required patients to pick up their medications in person at a hospital, doctor's office, or doctor's office. This restriction was eventually removed, allowing pills to be sent by mail. The lawsuit continues to focus on remaining restrictions that the ACLU says disproportionately impact patients who already face challenges accessing health care, such as low-income people and rural residents.
A Justice Department lawyer involved in the case did not immediately respond to an email from The Associated Press seeking comment on the ruling. They previously argued that the FDA was already reducing the burden by removing the in-person dispensing requirement.
Hawaii law allows abortions until the fetus is viable outside the womb. It is then legal if the patient's life or health is at risk. The state legalized abortion in 1970, making it the first state in the nation to allow abortions upon request.
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