Danco fights back after US court curbs abortion pill access

In another major setback for abortion care in the US, a US court has issued an order restricting the distribution of mifepristone through the mail.

The ruling by the New Orleans-based Fifth Circuit Court of Appeals has temporarily reinstated a requirement that mifepristone be prescribed and dispensed only after an in-person examination, in response to a lawsuit filed by the Republican-led state of Louisiana. The state has banned and criminalised abortion in nearly all cases, and classified mifepristone as a controlled substance.

Danco Labs – one of the companies that manufactures mifepristone, which it sells under the Mifeprex brand name – has petitioned the US Supreme Court in an emergency filing today to try to stay the ruling and allow access through mail-order, pharmacy, and telemedicine channels to continue. Mifepristone, given with misoprostol, is the most common way to terminate pregnancies in the US.

Last month, Louisiana's bid to introduce a temporary block on remote access to mifepristone while the Trump administration carries out a review of the drug was turned down by a federal judge.

Now, the appeals court has overturned that decision and said the injunction should apply in the meantime, in what has been described as the biggest threat to abortion access since the constitutional right to abortion – enshrined in the landmark Roe vs Wade ruling in 1973 – fell at the hands of the Supreme Court in 2022.

The FDA shored up the telemedicine route to the abortion pill in early 2023, making permanent a temporary suspension of the in-person requirement implemented during the COVID-19 pandemic, in order to ensure access for women in states that banned abortion.

"The regulation creates an effective way for an out-of-state prescriber to place the drug in the hands of Louisianans in defiance of Louisiana law," wrote the appeals court judges in their ruling, which will affect all states, regardless of whether they have restricted abortion access.

"Every abortion facilitated by FDA's action cancels Louisiana's ban on medical abortions and undermines its policy," they added.

Danco's filing, meanwhile, said the decision "injects immediate confusion and upheaval into highly time-sensitive medical decisions—and it forces Danco, FDA, certified Mifeprex providers, patients, and pharmacies all to guess at what is allowed and what is not."

Danco is asking the Supreme Court to consider the filing ahead of the summer recess, on the grounds that "the resulting chaos for patients, providers, pharmacies, and the drug-regulatory system is a quintessential irreparable harm that underscores the need for emergency relief from this Court."

The FDA launched its investigation into mifepristone at the request of 22 Republican attorneys general, leading to fears that politically-motivated efforts to curb access would prevail after the Supreme Court unanimously rejected a lawsuit in 2024 challenging the FDA's authority to regulate the drug and to relax access restrictions. There is no set timeline for the review to complete.

The American Civil Liberties Union (ACLU) said that if the Supreme Court does not move swiftly to block the ruling, "it will upend how people across the country get abortion and miscarriage care even in states where abortion is protected."

However, New York Attorney General Letitia James has pledged that abortion will continue to be legal in the state, despite the appeal court decision. "In New York, our laws ensure that anyone who needs abortion care can seek it here. That has not changed, and we will continue to protect access to abortion, including medication abortion," she said.

Photo by Claudio Schwarz on Unsplash