5th Circuit appears likely to restrict abortion pill access

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.

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 Food and Drug Administration’s approval of abortion drug 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, quickly 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He noted that just last month the FDA had withdrawn approval of a drug meant to reduce to risk of preterm birth for women with a history of going into labor before their babies reach full-term.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 by approving mifepristone in 2000 and easing access to the drug in 2016 and 2020.

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’s 2000 approval of mifepristone and subsequent decisions easing access to the drug.

A key fact issue emerged: Counsel for the government said the rate of 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.

The government argues Kacsmaryk’s order invalidating the FDA’s approval of mifepristone due to safety concerns is the first time a judge has ever done so for a drug that has been on the market for decades, and that letting his preliminary injunction stand would be an invitation for rulings on all kinds of drugs, which would destabilize the pharmaceutical industry.

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 plaintiffs countered that the FDA placed politics over women’s health in approving the drug.

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.

Kacsmaryk is a former federal prosecutor and general counsel of First Liberty Institute, a Christian conservative legal organization that advocates for religious liberty.

Following his order, the Biden administration and Danco sought a stay from the Fifth Circuit pending appeal.

A three-judge panel of the court stayed his injunction against the FDA’s initial approval of the pill, agreeing with the Biden administration that after 23 years it was too late to challenge it.

But they let the injunction stand against the FDA’s decisions to broaden its use from 7 to 10 weeks into a pregnancy and allow it to be distributed by mail.

Danco and the government secured a stay of the lower courts orders from the Supreme Court on April 21, returning the drug’s availability to the status quo as it was before Kacsmaryk’s injunction.

This is a developing story …