Berliner Tageblatt - US court rules abortion pill restrictions 'unlawful'

The case was brought by the nonprofit Center for Reproductive Rights in May 2023 on behalf of abortion providers across Virginia, Kansas, and Montana.

At stake were a set of rules called Risk Evaluation and Mitigation Strategy (REMS).

One forces prescribers to register with the manufacturer -- creating a national abortion provider database that advocates say could pose a safety risk for doctors.

Another requires pharmacies to be specially certified and maintain detailed records, and a third makes patients review counseling that critics called inaccurate.

In his ruling, entered Thursday but widely publicized on Friday, Judge Robert S. Ballou wrote that the new restrictions were "arbitrary and capricious" because "the FDA has steadfastly found, over the past quarter century, that mifepristone is a safe and effective medication."

He ordered the Trump administration to reconsider the rules, but did not void them and did not find that the FDA (Food and Drug Administration) had acted illegally in principle in trying to impose safety restrictions.

"This ruling is a win for science," said Nancy Northup, CEO at the Center for Reproductive Rights.

The case is separate from another currently in the Fifth Circuit, where the Republican-led state of Louisiana is asking the FDA to reimpose a ban on patients receiving mifepristone by mail or through pharmacies after a virtual visit with a provider.

In May the US Supreme Court temporarily maintained mail access to mifepristone, extending its stay of the Fifth Circuit's order that sided with Louisiana and would have halted such delivery.

The case is now back at that federal appeals court for full briefings.

It could eventually return to the Supreme Court.

Mifepristone, part of a two-pill combination for abortion, has been approved by the FDA since 2000 and is also routinely used to manage miscarriages. Since 2023, it has accounted for 63 percent of all US abortions.

Anti-abortion activists, however, have called the drug's safety into question, with some citing a study conducted by a conservative think tank that never underwent a formal peer review.

Separately, the FDA has ordered its own review of abortion pill regulations.

M.Ouellet--BTB