On Wednesday, Judge Matthew J. Kacsmaryk heard arguments in the case brought by anti-abortion group Alliance for Hippocratic Medicine, which seeks an emergency order to have the Food and Drug Administration withdraw its approval of mifepristone, one of two drugs known as the abortion pill. As the case is heard in federal court, a ruling for AHM would remove the drug from the national market.
Kacsmaryk said at the hearing he would rule on the case “as soon as possible,” the Lubbock Avalanche-Journal reported.
Per the Washington Post, Kacsmaryk signaled openness to AHM’s claim that mifepristone could be dangerous during the four-hour hearing, where Department of Justice lawyers represented the FDA. This was a claim DOJ lawyers firmly rebutted, noting overwhelming evidence that the drug is safe.
The FDA approved mifepristone in 2000 after vetting it for over four years. Its approval in the US came nearly a decade after it was authorized for use in the UK and Sweden. But in the hearing Wednesday, Kacsmaryk reportedly questioned DOJ lawyers about the FDA’s approval of mifepristone, suggesting the process had been done in an accelerated manner.
Kacsmaryk acknowledged the unprecedented nature of the case, according to the Associated Press, asking the anti-abortion group’s lawyer, Erik Baptist, if he knew of any prior instances where a court has ordered a ban on an FDA-approved drug. Baptist admitted there were none, but argued this was due to the FDA “stonewalling” the group’s previous objections to the drug in 2002 and 2019.
Baptist claimed that failing to ban mifepristone would result in “irreparable harm” to patients, suggesting that women die after using it. Government lawyers pushed back against this, saying 99.9% of people who take mifepristone experience no significant side effects. FDA data compiled by Advancing New Standards in Reproductive Health found that as of 2018, 24 people out of 3.7 million had died after using mifepristone, adding that the deaths could not be definitively linked to the drug.
However, Kascmaryk appeared interested in AHM’s arguments. Per the Washington Post, the judge asked Baptist if the plaintiffs believed the court could directly order the FDA to withdraw its approval of the drug, or simply instruct the department to begin the withdrawal process.
Following the overturn of Roe v. Wade in June 2022, many pregnant people living in states that have banned or seriously restricted abortion have turned to medication abortions to fill the gap. More than half of abortions in the US come from medication abortions, according to a 2022 survey from the Guttmacher Institute.
Studies of abortion laws show that banning abortions does not prevent them from happening — it just makes them more dangerous. According to a 2018 Guttmacher Institute report, abortions are performed at about the same rates worldwide but are the least likely to be done safely in countries where the procedure is forbidden.
Lorie Chaiten, senior staff attorney at the American Civil Liberties Union's Reproductive Freedom Project, told BuzzFeed News ahead of the hearing that even the existence of the lawsuit is “uncharted waters.”
“What the plaintiffs have asked for here is unprecedented,” Chaiten said. “Courts just simply do not jump in and remove drugs from the market, particularly not ones that have been on the market for [23 years].”
Mifepristone, along with misoprostol, is used to end a pregnancy of up to 10 weeks’ gestation. A healthcare provider must prescribe its use, and it can be given in person and by mail. Mifepristone blocks progesterone, the hormone needed to continue a pregnancy, and then misoprostol causes the uterus to get rid of its pregnancy tissue. While previously, medication abortions could only be distributed in person, in 2021, the FDA announced that abortion medication could be mailed to patients. And in January 2022, the FDA updated its guidance to allow retail pharmacies to provide abortion medication.
Chaiten said that, in a “normal world,” the case should have been dismissed from the start. “There are processes in place that the FDA follows if it has reason to think that it should be looking at whether it should review or withdraw a drug from the market. But what the plaintiffs have asked for here is really without any basis in the law.”
Chaiten said if the medication abortion is not FDA-approved, then it doesn’t matter what the state’s law is regarding abortion. “Even in states where abortion is legal, if it’s an unapproved drug, there could be legal repercussions for continuing to prescribe it and certainly for these sponsors to continue to distribute it,” she said.
Though details of federal cases are usually announced on a publicly available court docket, Kacsmaryk attempted to conceal news of the hearing to avoid public ire. In a conference call on Friday, according to the Washington Post, Kacsmaryk told attorneys he had received threats and said he would try to keep the hearing off the docket until late Tuesday to circumvent protests.
Though Kacsmaryk did not succeed in keeping knowledge of the hearing under wraps, access to Wednesday’s proceedings remained extremely limited. Only 19 journalists and 19 members of the public were reportedly permitted inside the courtroom, and recording was forbidden. A line for those hoping to snag one of the 38 seats started forming outside the courthouse before sunrise.
A small gathering of protesters gathered outside the courthouse during the hearing, some holding signs bearing pro-abortion rights messages. One dressed in costume, donning a kangaroo suit under a judicial robe, mocking the proceedings as a “kangaroo court.”
Kacsmaryk, the Northern District of Texas judge who ruled on the case, was appointed by then-president Donald Trump in 2019. He has a track record of opposing marriage for same-sex couples, and last year, he ruled that Texas minors couldn’t get birth control without a parent’s permission.
In a statement to BuzzFeed News, the FDA said it “does not comment on possible, pending or ongoing litigation.”