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Judge Kacsmaryk promises to rule ‘as soon as possible’ on request to issue a preliminary injunction ordering the FDA to withdraw its approval of mifepristone

by | Mar 16, 2023

By Dave Andrusko

After more than four hours of oral arguments, Judge, Matthew J. Kacsmaryk said he would rule “as soon as possible” whether to grant the plaintiff’s request to issue a preliminary injunction ordering the FDA to withdraw its approval of mifepristone or to withdraw the drug completely while the case proceeds through trial.

Covering all their bases in advance, the Justice Department requested that if Judge Kacsmaryk does side with the Alliance for Hippocratic Medicine, he “put the decision on hold to give the government time to appeal to the U.S. Court of Appeals for the 5th Circuit,” according to Melissa Quinn and Mark Hooper of CBS News.

The Alliance, which is a coalition of pro-life groups and four pro-life physicians “seeks to overturn the approval nearly 23 years ago of mifepristone — the first pill in the two-drug medication abortion regimen — and to prevent the second drug in the regimen, misoprostol” from being used for abortion.

Not surprisingly, the attorneys for the Alliance and attorneys representing various parties on the other side sparred over a whole range of issues. For example, Pam Belluck and Allison McCann of the New York Times wrote

The hearing devoted a significant amount of time to discussing the regulation mifepristone was initially approved under. Called Subpart H, it allowed for approval of drugs “that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses.”

“Pregnancy is not an illness,” Mr. [Erik] Baptist said. …

Mr. Baptist also said that because studies the F.D.A. used for the approval had involved doctors’ examining patients with ultrasound before prescribing mifepristone, the agency should have required ultrasound to determine whether patients were early enough in pregnancy to use the drug and to rule out ectopic pregnancies, a dangerous condition in which the embryo grows outside the uterus and cannot result in a live birth.

Justice Department lawyer Daniel Schwei countered

that the F.D.A. had required that doctors determine pregnancy stage and rule out ectopic pregnancies but allowed doctors to use various methods, including ultrasound.

When questioning Baptist, Judge Kacsmaryk asked for an example of a court intervening so many years after the FDA had given its approval.  “Baptist said he could not recall past instances, though he accused the FDA of ‘stonewalling’ challenges to its mifepristone approval filed through citizen petitions in 2002 and 2019.”

Later in the hearing, “Baptist raised other times the FDA had suspended or withdrawn drugs based on court cases in other contexts, arguing those cases showed that Kacsmaryk had the authority to grant the plaintiffs’ request,” Tierney Sneed reported for CNN.

Finally, according to the Washington Post

Kacsmaryk also solicited guidance from Baptist on how to shape a possible order, asking whether the conservative group believes he could unilaterally direct the FDA to withdraw its approval, or just begin that process.

The court can “on its own accord” order the FDA withdrawal, Baptist said.

Categories: Judicial