Drugmaker, DOJ Ask Supreme Court to Block Ruling Against Abortion Pill

Packages of Mifepristone tablets are displayed in Rockville, Md., on April 13, 2023. (Anna Moneymaker/Getty Images)

The company that makes a widely used abortion drug asked the U.S. Supreme Court on April 14 to block a recent ruling that limits the drug’s availability, as did the U.S. Department of Justice (DOJ).

Danco Laboratories manufactures mifepristone, used by many women to terminate pregnancies. Under an appeals court ruling this week, the drug cannot be prescribed by mail. A separate ruling in a different court ordered no new limits on mifepristone in 17 states.

The competing rulings have resulted in “an untenable limbo, for Danco, for providers, for women, and for health care systems all trying to navigate these uncharted waters,” Danco said in a filing to the Supreme Court.

The company said the court should block the ruling that limits access to mifepristone the U.S. Court of Appeals for the Fifth Circuit entered.

The DOJ also asked the nation’s top court to step in. If it does not, the appeals court order “would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority,” Solicitor General Elizabeth Prelogar wrote in a filing.

At least five justices would need to approve the requests for a stay on the lower court ruling to be entered.

The Alliance Defending Freedom, which is representing groups that challenged the U.S. Food and Drug Administration (FDA) approval of mifepristone, said that the Supreme Court should turn down the new requests.

“The FDA illegally approved chemical abortion drugs and has evaded its legal responsibility to answer the American people’s questions for two decades,“ Erin Hawley, an alliance lawyer, said in a statement. ”The 5th Circuit rightly required the agency to prioritize women’s health by restoring critical safeguards, and we’ll urge the Supreme Court to keep that accountability in place.”

Background

Mifepristone was approved by the FDA in 2000, with some limitations. Starting in 2016, the agency rolled back many limitations, including revoking the requirement to be prescribed in person.

U.S. District Judge Matthew Kacsmaryk, a Trump appointee, ruled this month that the FDA had to halt its approval because of signs the agency violated its statutory duty in evaluating the drug’s safety.

He said the order would not be imposed for a week, giving the government time to appeal.

An appeal partially overturned the order. A panel of appeals court judges said that the government had made a strong case regarding Kacsmaryk’s order as it pertained to the drug approval. But the government did not show that the FDA’s actions from 2016 “were not arbitrary and capricious,” the judges said.

The panel that ruled consisted of Circuit Court Judges Catharina Haynes, a George W. Bush appointee; Kyle Engelhardt, a Trump appointee; and Andrew Oldham, a Trump appointee.

Possible Shutdown

While the ruling does not completely revoke access to mifepristone, the result if left unblocked will be the same as if the approval was paused, Danco asserted.

“The result is a regulatory mess that will irreparably injure Danco by making it exceedingly difficult, if not impossible, for Danco to continue selling its only product,” lawyers for the company said.

To meet the pre-2016 standards, Danco would have to revise product labels, packaging, and promotional materials as well as make other changes, such as amending contracts, the company said. Even before making changes, it would have to submit paperwork to the FDA and get approval. That’s a process that usually takes months, and could be for nothing if the injunction is entered but ultimately modified or rescinded.

“In the face of this uncertainty, Danco may well be forced to halt operations,” Danco said.

Prelogar told the Supreme Court that the lower court order, if not blocked, would render all mifepristone doses already distributed misbranded and that the FDA and Danco “would have to adjust the drug’s labeling to account for the lower courts’ actions—a process that could take months.”

She added, “The resulting disruption would deny women lawful access to a drug FDA deemed a safe and effective alternative to invasive surgical abortion.”