HONOLULU (KHON2) — A Hawaiʻi federal judge ruled that the Food and Drug Administration’s restrictions on a medication abortion pill violated federal law.
This case comes after the Trump administration announced that the FDA would conduct a new review of its medication abortion pill regulations, based on a non-peer-reviewed paper.
The ruling, which came in on Oct. 30, addressed the FDA’s attempted regulation on mifepristone, with plaintiffs in the case saying the regulation is unnecessary given the drug’s safety.
U.S. District Judge Jill Otake came to the conclusion that the FDA violated the Administrative Procedure Act by not providing a solid explanation for further restriction of mifepristone, court documents said.
Otake ruled in favor of the plaintiffs, which included a Kauaʻi doctor. The ruling upheld previous regulation but requires solid and academically-based explanations for any future regulations.
Supporters of the ruling said that the new, attempted regulation by the FDA and Health and Human Services Secretary Robert F. Kennedy Jr. is unneeded.
“Despite decades of real-world experience and mountains of evidence proving mifepristone’s safety, the FDA regulates this medication more heavily than 99% of prescription drugs. Now, Secretary Kennedy is using more junk science to lay the groundwork for making it even harder to get a medication abortion,” Julia Kaye, senior staff attorney with the ACLU Reproductive Freedom Project, said.
Mifepristone has been approved by the FDA for approximately 25 years and does carry risks, but court documents said that risks are “exceedingly rare, generally far below 0.1% for any individual adverse event.”
As it exists, mifepristone can be prescribed if certain conditions are met, including determining if other pregnancy intervention techniques could be utilized, the drug be used only in healthcare settings observed by a doctor and patients signing an agreement form.
Those regulations are permitted to continue, but any further limitations should have solid ground to stand on, documents said.