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.
See here and here for the background. I can’t overstate how ridiculous this all is, and that includes the extreme restrictions on coverage of the hearing, for which you literally had to be there or at a single courthouse in Dallas, but only a handful of people were allowed at the courtroom, and cellphones were banned, so no live-tweeting. All for a hearing at which one hand-picked judge could severely curtail access to abortion for millions of women across the country, based on vibes. I really hope I’m wrong, but I don’t see anything in the coverage I’ve read to suggest this guy will do anything other than what he clearly wants to do. We’ll find out soon. Jezebel, the Associated Press, Slate, Daily Kos, and NBC News have more.
UPDATE: From Slate, “If Kacsmaryk rewrites the history of mifepristone’s approval as grounds to pull it from the market, his decision should command no respect or acquiescence from anyone—not the FDA, not abortion providers, and certainly not the public at large.”