Mifepristone FDA approval enjoined

A judge in Texas has enjoined FDA approval of mifepristone, the most common abortion pill, while a lawsuit challenging its safety is still pending.

Mifepristone safety injunction

Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas, issued the stay on Friday afternoon (April 7.)

In his order, he gave the government seven days “to seek emergency relief” through the Fifth Circuit Court of Appeals.

Kacsmaryk ruled in a lawsuit by Alliance Defending Freedom. (Alliance for Hippocratic Medicine et al. v. F.D.A.) The plaintiffs argued that the FDA did not adequately vet mifepristone, known originally as RU-486, before approving it in 2000. In his findings, Kacsmaryk wrote:

Before Plaintiffs filed this case, FDA ignored their petitions for over sixteen years, even though the law requires an agency response within “180 days of receipt of the petition…,”… Plaintiffs have credibly alleged past and future harm resulting from the removal of restrictions for chemical abortion drugs.

And:

The Court does not second-guess FDA’s decision-making lightly. But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.

The judge also invoked the Comstock Act, a law still on the books forbidding shipment of abortion drugs by mail.

ADF also assisted in the filing of the landmark case of Dobbs v. Jackson Women’s Health Organization.

Reaction

The Alan Guttmacher Institute, the science arm of Planned Parenthood, condemned the ruling.

An activist went further:

So did Senator Elizabeth Warren (D-Mass.):

The Biden administration has said they would appeal. But Rep. Alexandria Ocasio-Cortez (D-N.Y.), on national television, openly encouraged the Biden administration to ignore the ruling.

Senator Ron Wyden (D-Ore.) urged the same in a statement that LifeZette quoted:

There is no way this decision has a basis in law. It is instead rooted in conservatives’ dangerous and undemocratic takeover of our country’s institutions. No matter what happens in seven days, I believe the Food and Drug Administration has the authority to ignore this ruling, which is why I’m again calling on President Biden and the FDA to do just that.

Another judge in Washington State issued a clashing ruling, affecting distribution of mifepristone in seventeen States that still allow abortion. (Texas does not.)

This virtually guarantees a split in the circuits – the Fifth, including Texas, and the Ninth, including Washington State. That will force the U.S. Supreme Court to grant review in both cases.