(CN) — The Biden administration and counsel for anti-abortion doctors aiming to get mifepristone off the market cited conflicting statistics about the drug's safety in a two-hour hearing Wednesday before the Fifth Circuit.
The parties sparred over a key fact issue. Counsel for the government said the rate of serious complications for women taking mifepristone is less than 1%.
But the plaintiffs’ attorney said it was unclear where they got that number. She observed that the current FDA medication guide for the drug, updated in January, states that between 2.6% and 4.9% of women will present to an emergency room.
Mifepristone causes miscarriages by blocking a hormone called progesterone that readies the uterus to carry an embryo. In the U.S., it is typically prescribed in tandem with misoprostol.
Misoprostol, which can induce abortions but is not as effective as the two-pill regimen, is taken 24 to 48 hours after mifepristone and causes contractions that clear the uterus.
According to Danco Laboratories LLC, the maker of mifepristone which has intervened as a defendant in the case, and the government, mifepristone is safer than most drugs and pregnancy itself with only five deaths for every 1 million uses.
By comparison, the U.S. Centers for Disease Control and Prevention says the maternal mortality rate in the United States for 2021 was 39.2 deaths per 100,000 live births.
The method has become preferred over surgeries in recent years. In 2020, 53% of the more than 900,000 abortions in the U.S. were done by pill, rising from 39% in 2017.
Sarah Harrington, a Justice Department attorney representing the Food and Drug Administration and its commissioners, opened her arguments by calling U.S. District Judge Matthew Kacsmaryk’s April 7 order rejecting the FDA’s approval in 2000 of mifepristone an “unprecedented and unjustified attack on the FDA’s scientific expertise.”
U.S. Circuit Judge James Ho, a Donald Trump appointee and former clerk for Supreme Court Justice Clarence Thomas, challenged that statement.
He noted that just last month the FDA had withdrawn approval of a drug meant to reduce to risk of preterm birth for women with a history of going into labor before their babies reach full-term.
“The FDA can make that determination based on exercising its own scientific expertise,” Harrington replied. “But it’s not a court’s role to come in and second-guess that expertise and no court has ever done that.”
Ho urged Harrington to focus on the facts of the case “rather than have this sort of FDA-can-do-no-wrong theme.”
The plaintiffs are anti-abortion doctors and national medical associations. They filed the lawsuit in November 2022 in Amarillo federal court, claiming the FDA had violated the Administrative Procedure Act with its initial approval of mifepristone and by easing access to the drug in 2016, 2019 and 2021.
Throughout the two-hour hearing, the three judges on the panel and attorneys focused on whether Kacsmaryk had improperly determined plaintiffs have standing to challenge the FDA.
Harrington stressed that in declarations submitted for the case plaintiff doctors never said that over their religious or conscience objections they had been forced to do emergency abortions on women who needed procedures after taking mifepristone.
"And it would be surprising if they could allege that because they have robust conscience protections in federal and state law," she added.
U.S. Circuit Judge Jennifer Walker Elrod, a George W. Bush appointee, pointed to a declaration in which a physician stated she had performed surgery on at least 12 women after a failed chemical abortion, sometimes including removing the embryo or fetus. "Is that not akin enough, removing the embryo or fetus in a surgical proceeding?" Elrod asked.
"It doesn’t ever say she was compelled to do that against her religious beliefs," Harrington said.
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