Drugmaker files emergency appeal to restore abortion pill access in US

A company that makes the abortion drug mifepristone asked the U.S. Supreme Court on Saturday to hit pause on Friday’s lower court ruling that cut off telemedicine access to the pills nationwide, including in states where abortion is legal.

The emergency appeal asks the high court to temporarily restore a federal policy that allows the pills to be prescribed online and delivered by mail, arguing that failing to do so would cause “immediate chaos” and leave patients around the country in limbo.

The pharmaceutical company Danco requested an immediate administrative stay while the case makes its way through lower courts. At the same time, it asked for the Supreme Court to immediately take up the issue and hear arguments before its summer recess.

Danco first asked the 5th Circuit Court of Appeals on Friday night to put a one-week hold on its own unanimous ruling that reimposed a prior U.S. Food and Drug Administration policy mandating that patients only obtain the pills in person from a physician — a decision the company noted “renders inoperable an agency action that has already been in effect for years.”

The court ruled 3-0 in favor of arguments from Louisiana that the Biden-era regulations on the drug that expanded online and mail access threatened the safety of pregnant women and the sovereignty of Louisiana, which has banned abortion in nearly all circumstances.

When the court did not respond to the companies’ request, Danco turned to the Supreme Court for relief, arguing that “tremendous uncertainty will surround the legal status of mifepristone throughout the country” unless the high court steps in.

GenBioPro, the other maker of mifepristone, is expected to soon file its own appeal.

Even a temporary disruption of access to mifepristone will have massive implications. The medication is used in nearly two-thirds of all pregnancy terminations, and a quarter of patients depend on telehealth to obtain them. The ruling also cuts off telemedicine prescription of the drug for non-abortion purposes, such as easing miscarriages.

In the wake of Friday’s ruling, medical and progressive advocacy groups stressed that doctors can still use telehealth to prescribe the other abortion pill — misoprostol. The drug can be used on its own to end pregnancies and carries fewer restrictions because it is used for an array of other purposes, including treating ulcers and stopping hemorrhages.

“Extremist attempts to limit access to abortion have not been successful at stopping the pills-by-mail model of safe abortion care, and this court decision will also not stop access,” said Elisa Wells, the co-founder of the website Plan C, which provides information about how to obtain abortion pills regardless of state bans.

Still, as all parties waited for the justices to intervene, the 5th Circuit’s bombshell ruling reverberated through the pharmaceutical industry. Biotech industry leaders, dozens of whom previously urged the FDA to stay the course on mifepristone and not let political and ideological forces impact regulation of the drug, warned of negative implications far beyond abortion.

“By circumventing the FDA’s regulatory authority, this ruling threatens the evidence-based framework that has enabled generations of Americans to access safe, innovative medicines,” said Shehnaaz Suliman, CEO of ReCode Therapeutics. “The integrity of that process is not procedural — it is in the best interests of the public’s health.”

The decision, industry leaders have warned, could invite challenges to any other medication an interest group opposes — from hormones for trans patients to substance abuse treatments to vaccines.

“I am deeply invested in ensuring that health care policy remains grounded in science, supports innovation, and protects patient access,” said Julia Owens, CEO of Basking Biosciences Inc. “Decisions like this risk undermining all of those priorities.”