Putting women at risk

The FDA’s rubber-stamp approval of a second generic mifepristone is being defended as just another bureaucratic box-check. It was anything but. The approval of a generic mifepristone was a policy choice—and one that reveals just how detached our institutions have become from moral reality. The decision’s defenders champion technocracy while ignoring the high human costs.

On Sept. 30, the FDA approved Evita Solutions’ generic abortion drug. The agency framed its approval as a mere technical matter: The pill is “bioequivalent” to the abortion drug Mifeprex, thus it qualifies for approval. That’s how bureaucrats justify their work—as if ending unborn lives were no more consequential than approving a pain medication.

The decision was no mere bureaucratic box-check. Rather, the FDA had just committed to undergoing a full safety review of the abortion drug mifepristone in light of new data that suggests that as many as one in ten women who take the drug suffer a severe adverse health event. On X, Secretary Kennedy said, “The Biden administration removed mifepristone’s in-person dispensing rule without studying the safety risks. We are filling that gap." Last month, the agency sent a letter to state attorneys general “pledging to review all the evidence—including real-world outcomes—on the safety of this drug.” It acknowledged that recent studies “point to serious risks when mifepristone is used without proper medical oversight.”

But approving a second generic drug subject to the same lax standards hardly fills the safety void imposed by the Biden administration. It exacerbates it.

To be sure, the Hatch-Waxman Act streamlined the approval process for generics. The statute emphasizes showing bioequivalence, that the generic operates in the human body like the name-brand drug. If a drug is bioequivalent, then the safety findings for the original drug are presumed to carry over. But it makes no sense to approve a generic drug based on a name-brand drug’s safety findings, when recent studies show that the original drug poses “serious risks” to women’s health. My husband, Sen. Josh Hawley, pointed out this contradiction on X: “FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they've just greenlighted new versions of it for distribution.”

Make no mistake, mifepristone is not your ordinary drug. Most obviously, it intentionally takes the life of an unborn child. Drugs approved by the FDA are supposed to provide a “therapeutic benefit.” Yet pregnancy is not a disease—and rather than curing an illness, mifepristone takes a human life.

The abortion drug also poses serious risks to women. Its own label acknowledges that about one in 25 women will end up in the emergency room after taking the drug. And it has a black box warning explaining that serious infections and even death can result when women take the drug. Yet the Biden FDA stripped away a crucial safeguard for women: the in-person dispensing requirement that allowed doctors to examine women for dangerous conditions like ectopic pregnancies. Instead, the Biden FDA permitted out-of-state doctors to dispense the abortion drug by mail without examining (or even talking to) their patient. In Dobbs v. Jackson Women’s Health Organization, the Supreme Court returned the issue of abortion to the states. But the Biden administration’s permission slip for mail-order abortions renders this promise empty.

The Biden FDA’s removal of safeguards also leaves women to take a risky drug all alone, and it opens the door to coercion and abuse. We’ve already seen numerous examples of partners or parents ordering the drugs and forcing the pregnant mom to end the life of her unborn child.

Evita’s application also erases the very women it claims to empower. The materials it submitted to the FDA don’t even refer to women but talk about pregnant people. That’s no accident. Big abortion is so committed to ideology it can’t acknowledge the biological reality that only women get pregnant. That isn’t science. That’s ideology hiding behind technocracy. And the FDA sadly went along.

Approving yet another high-risk abortion drug is not about empowering women. It is about expanding abortion at any cost, even if it means risking women’s health—or pretending that women do not even exist.