(AP) — The U.S. Food and Drug Administration continues to overly restrict access to mifepristone, a medication for abortions and miscarriage management, a lawyer for the American Civil Liberties Union argued Friday in a lawsuit by a Hawaii doctor and healthcare associations challenging the legality of the restrictions.
They are asking a judge to find that the FDA violated the law by restricting a safe medication without scientific justification, but stop short of flat-out seeking an immediate elimination of the restrictions, which currently include special certification for prescribers and pharmacies and requiring patients to review a counseling form.
Plaintiffs are taking the “more modest approach” to give the agency an opportunity to correct its errors, Julia Kaye, senior staff attorney with the ACLU Reproductive Freedom Project, said in court.
U.S. District Judge Jill Otake in Honolulu didn’t say when she would issue a ruling.
Friday’s hearing comes as the pill used in most U.S. abortions continues to be ensnared in politics that have plagued it for nearly a decade, with many wondering if it will be further restricted under President Donald Trump’s Republican administration.
The case dates to 2017 and has spanned both Republican and Democratic administrations.
“All along, the FDA has dug its heels in and attempted to justify these extreme restrictions without ever providing a credible justification,” Kaye told The Associated Press ahead of the hearing. “And in the face of a mountain of scientific evidence confirming the safety.”
Kaye noted that during former President Joe Biden’s administration, the FDA concluded that requiring the pill to be picked up in person didn’t provide a safety benefit and that the requirement should be lifted.
The original lead plaintiff was a doctor in a small town on the island of Kauai where he had some colleagues who opposed abortion. At the time, a key restriction required patients to pick up the medication in person at a hospital, clinic or medical office, which meant the doctor would have had to involve many of his colleagues in order to stock and dispense the medication, Kaye said.
The key barrier was eventually removed and the pill can be sent through the mail. The original doctor left Hawaii and the lawsuit continues to focus on the remaining restrictions that the ACLU says in a court filing “disproportionately impact patients who already face difficulties accessing healthcare,” such as those who are low-income or live in rural areas.
Attorneys with the U.S. Department of Justice say in court documents that the FDA has already reduced the burden by removing the in-person dispensing requirement. The FDA’s statements about the safety of mifepristone are contingent upon the restrictions being in place, Noah Katzen, an attorney representing the Justice Department, said in court Friday. He also disputed that the plaintiffs, including another Kauai doctor who has stepped in as lead plaintiff, have legal standing to challenge the restrictions.
Katzen declined to comment to the AP after the hearing.
Hawaii law allows abortion until a fetus would be viable outside the womb. After that, it’s legal if a patient’s life or health is in danger. The state legalized abortion in 1970, when it became the first in the nation to allow the procedure at a woman’s request.
“For better and worse, the FDA’s policy on medication abortion impacts patients in every state in the nation, including states where abortion is legally protected,” Kaye told the AP.
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