Abortion Pill Ban Gets a Second Chance in Appeals Court

(Bloomberg) — Defenders of the abortion pill got a cold reception Wednesday from a US appeals court composed mostly of Donald Trump appointees hearing arguments on whether to uphold a ban on the drug imposed in April by a federal judge in Texas.

A three-judge panel on the 5th US Circuit Court of Appeals in New Orleans is reviewing US District Court Judge Matthew Kacsmaryk’s order banning mifepristone on the grounds that the Food and Drug Administration improperly approved it in 2000. The Circuit won’t rule immediately, but the Supreme Court has already stayed Kacsmaryk’s order pending appeal.

Lawyers for the federal government and mifepristone manufacturer Danco Laboratories have characterized Kacsmaryk’s order as “unprecedented” because it appears to be the first time a federal judge has challenged the FDA’s determination that a drug is safe.

During arguments on Wednesday, Circuit Judge James Ho bristled at that characterization. He interrupted FDA lawyer Sarah Harrington during her opening statement to contest her description of the Texas order, and he questioned Danco attorney Jessica Ellsworth on her assertions that questions of drug safety should not be determined by the courts.

“I don’t understand the argument that the FDA should not be questioned,” Ho said.

‘Unusual Remarks’

Circuit Judge Jennifer Walker Elrod criticized language Ellsworth used to describe Kacsmaryk’s order. In court filings, the Danco lawyer referred to the Texas ruling as “unprecedented” and a “judicial assault,” which the Elrod said were “unusual remarks” about a judicial decision.

“You think it’s appropriate to attack the district court personally in that way?” Elrod said.

Ellsworth largely defended the language, stating that the case is unusual and her descriptions of Kacsmaryk’s decision reflect that — but she said she may have softened her tone if she’d had more time to prepare the briefs.

Amarillo, Texas-based Kacsmaryk said in his ruling that it was clear the FDA overstepped its authority when it first approved mifepristone and suggested the agency “faced significant political pressure” to advance the drug. He issued a so-called preliminary injunction that would’ve blocked access to mifepristone while the lawsuit before him continued.

The Circuit will now consider whether to allow Kacsmaryk’s order to take effect instead. The Biden administration wants the appeals court to block the Texas order. Even if the appeals court panel upholds the order, it will not go into effect until the matter returns to the Supreme Court.

Abortion Opponents

The legal fight over mifepristone got its start in November when a conservative legal group, Alliance Defending Freedom, sued in Amarillo to challenge the FDA approval on behalf of anti-abortion medical organizations and doctors. Lawyers for the group say that the plaintiffs filed a citizen petition with the FDA in 2002 asking officials to review its approval of the drug, but the petition was rejected in 2016.

Their lawsuit alleges the FDA fast-tracked approval of the drug without sufficient scientific evidence through a process reserved for accelerating authorization of drugs used to treat illnesses like cancer and HIV.

It also takes issue with several subsequent decisions by the agency to loosen restrictions on the pill, including a 2016 move to extend the window of use from seven weeks of gestation to 10 weeks and a more recent decision permitting the pill to be distributed through the mail.

Lawyers for the FDA have defended all of the agency’s decisions, arguing that officials followed the law when they approved the drug for use and that mifepristone continues to be a safe and effective method for terminating a pregnancy.

The government also argued the lawsuit should be thrown out because the plaintiffs waited too long to file their complaint after the drug was approved and their citizen petition was rejected.

The appellate case is Alliance for Hippocratic Medicine v. US Food and Drug Administration, 23-10362, 5th US Circuit Court of Appeals.