Judge hears challenge to FDA approval of abortion drug

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The future of medication abortion in the United States remains up in the air after a federal judge heard arguments Wednesday in a suit challenging the Food and Drug Administration’s long-standing approval of mifepristone.

U.S. District Judge Matthew Kacsmaryk said he would rule “as soon as possible” on the challenge brought by the Alliance Defending Freedom, a conservative, anti-abortion law firm.

ADF is asking Kacsmaryk to suspend — and ultimately withdraw — the FDA’s approval of the medication, which would have nationwide implications, especially in states where abortion remains legal. In the hearing, a lawyer for ADF conceded that this would be unprecedented, but argued that the court had the authority to intervene to prevent harm.

Lawyers for the Department of Justice and Danco Laboratories, the pharmaceutical company that produces generic mifepristone, argued that the lawsuit is meritless.

Granting a preliminary injunction would be “depriving patients and doctors of a safe and effective drug,” argued Julie Straus Harris, with the DOJ.

Since it was initially approved in 2000, mifepristone has been found to be overwhelmingly safe and effective for terminating pregnancies. Citing that body of evidence, the FDA has recently relaxed restrictions on the medication, which is used in the majority of the abortions in the United States.

In the suit, ADF is representing anti-abortion medical organizations and doctors who argue they have been harmed by having to treat patients who have experienced adverse effects from the medications — and that they anticipate increased harm as a result of these loosened restrictions.

They also argue the drug was initially approved improperly under an FDA regulation that fast-tracks drugs that treat serious illnesses.

“Pregnancy is not an illness,” said Erik Baptist, a lawyer for ADF, in Wednesday’s hearing. “Mifepristone doesn’t treat anything.”

Kacsmaryk, appearing to give weight to that argument, listed off all the drugs that were approved under this regulation before mifepristone, most of which treat HIV and cancer. Separately, he summarized Baptist’s argument as asking the court to “deem one of these not like the others.”

The hearing, which ran more than four hours in Kacsmaryk’s Amarillo courtroom, covered a wide range of arguments. But the central question before Kacsmaryk is not as much about abortion as it is about administrative procedure — and whether the plaintiffs have any right to bring this lawsuit at all.

The DOJ claims that the statute of limitations on the plaintiffs’ complaints has expired and they have not satisfied the requirements to reopen the FDA’s approval of mifepristone.

Mifepristone was approved by the FDA in 2000. Two years later, anti-abortion groups filed a citizen petition asking the FDA to reconsider. The FDA did not respond until 2016, when it rejected the question — on the same day that it released new guidance loosening restrictions on the drug.

Erin Morrow Hawley, an attorney for ADF, said this “agency gamesmanship” — as well as changes to the drug’s dispensing requirements in 2016 and 2021 — gives the court an opening to reconsider the approval.

The DOJ countered that there is a process to challenge delays, which the plaintiffs did not undertake, nor have they explained the gap between that 2016 petition rejection and the 2022 lawsuit filing. Lawyers for the government also argued that the doctors and medical associations who brought this lawsuit have not demonstrated sufficient harm.

In declarations, these medical providers laid out cases where they had to treat patients experiencing adverse effects from medication abortion.

Courts have long recognized that abortion providers have standing to bring suits challenging restrictions on behalf of their patients. ADF argued that this should similarly extend to doctors who oppose abortion.

Straus Harris, representing the FDA, questioned that argument, pointing out that abortion providers and their patients are pursuing the same medical procedure. In this lawsuit, doctors and patients are “diametrically opposed,” in that the doctors want to block medical care their patients may have otherwise sought out.

Kacsmaryk, in questioning the DOJ, raised an argument from the U.S. Supreme Court ruling in June Medical Services v. Russo, a 2020 case that knocked down a Louisiana law restricting abortion access. But he cited a dissent from Justice Samuel Alito that argued abortion providers do not have close relationships with their patients and thus don’t have standing.

Before joining the federal bench in 2019, Kacsmaryk worked on anti-abortion causes as deputy general counsel for First Liberty, a religious liberty law firm in Plano. As the only federal judge in Amarillo, he is automatically assigned 95% of the cases filed in that division.

He initially tried to conceal this hearing, keeping it off the docket after he scheduled it during a status hearing on Friday. According to a transcript of the hearing, he initially planned to wait until Tuesday night to announce it publicly, citing security concerns. After The Washington Post reported on the hearing over the weekend, it was docketed Monday afternoon.

At the conclusion of the hearing, Kacsmaryk thanked everyone who “endured the necessary planes, trains and automobiles” it took to get to Amarillo. And he applauded the “excellent, superb” arguments from both sides, saying it was a “smorgasbord of appellate-grade work.”

It will have to be: Whatever Kacsmaryk rules, it’s all but guaranteed that this case will end up before the 5th U.S. Circuit Court of Appeals in New Orleans.

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