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Men Explain Abortion Drugs to the FDA

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Reverend Patrick Mahoney speaking at a protest against the FDA’s ruling that pharmacies can dispense abortion pills to people with prescriptions, Washington, D.C., January 18, 2023

When the Supreme Court overruled Roe v. Wade, it put abortion rights at the mercy of state legislatures. Now the choices of pregnant people across the country are in the hands of a Texas judge. Matthew Kacsmaryk, who sits in Amarillo, is expected to issue a ruling in the coming days that could make medical abortions much harder to get. If he does, it won’t be because the legal arguments are convincing but because he was hand-picked by plaintiffs who trust he will side with them anyway. Before Donald Trump appointed him to the Northern District of Texas, Kacsmaryk was deputy general counsel at a conservative Christian organization. As a judge in other cases, he has proven willing to do what the plaintiffs need him to do now: take a whip to administrative agencies while flouting the rules that bind courts.

The case began in November, when anti-choice medical groups and doctors sued the Food and Drug Administration (FDA). They’re represented by a right-wing legal organization called the Alliance Defending Freedom, which also sues to undermine gay and trans rights. Among other things, the lawsuit argues that the FDA violated its own procedures when, in 2000, it approved a drug called mifepristone for use in medication abortions. Mifepristone blocks progesterone, the hormone that prepares the uterus for an embryo, and is taken with misoprostol, which empties the uterus, to safely end a pregnancy in the first ten weeks. Most abortions in the US rely on the two-step regimen.

Kacsmaryk will decide whether to grant a preliminary injunction to make the FDA withdraw its approval. If he makes this unprecedented move, mifepristone could be pulled from shelves right away, at least until the case is resolved. This would force pregnant people who want abortions to get them surgically or by taking only misoprostol, which works on its own slightly less effectively and with more potential side effects. Some analysts have cautioned against such catastrophic predictions. Three legal scholars recently argued in Slate that Judge Kacsmaryk can at most make the FDA begin a lengthy process for taking away approval. Even if the drug loses approval, the agency could keep it on the market by telling distributors it won’t go after them. And however Kacsmaryk rules, his decision will be appealed to a higher court.

But at the very least, the ruling expected in Alliance for Hippocratic Medicine v. FDA will sow confusion about how and where people can end pregnancies. This alone could make the drugs harder to find. Under Biden the FDA has eased access to medication abortions by allowing mifepristone to be sent by mail and, more recently, sold at certified pharmacies. Yet last week Walgreens announced that it won’t provide the drug in twenty-one states, including four where abortion is still legal. A spokesperson asked about the company’s announcement told The New York Times that the state of abortion law was “very complex and in flux.”

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The FDA approved mifepristone after rigorous testing showed it was safe. Against that expert determination, the Texas lawsuit has lodged twisted science and unfounded charges of sloppiness. The complaint has the cocksure tone of a man challenging a specialist after reading one article. It misrepresents the agency’s regulations in an attempt to show they were violated. 

The suit’s central argument hangs on one word. The FDA approved mifepristone through an expedited process reserved for drugs that treat serious “illness,” a classification that the plaintiffs claim doesn’t include unwanted pregnancy. Only a narrow definition of sickness would exclude pregnancy’s potential complications and certain discomfort, but the bigger issue—the one that the FDA has raised in its own defense—is that the text of the agency’s regulations doesn’t say what the plaintiffs claim. Elsewhere, “illnesses” are discussed in the same breath as “conditions,” a broader term that more clearly describes unwanted pregnancies. The FDA has understood the accelerated approval process to be appropriate for drugs that treat either.

The plaintiffs have also tried to make the FDA look lax by inventing standards the agency fell short of. One of their complaints is that the agency’s clinical trial didn’t exactly replicate instructions on the drug’s label. For example, patients in the trial had to get an ultrasound, even though the label didn’t instruct ordinary people taking mifepristone to do so. This is true, but beside the point. As the FDA’s brief shows, there’s no requirement that the protocols used during studies of a drug’s safety must mirror its label.

And yet even as they ask the court to bind the FDA with rules that don’t exist, the plaintiffs also want Kacsmaryk to unlawfully relax limits on his own power. One such limit is the basic principle that courts can only decide cases brought by plaintiffs with concrete, specific injuries that will be remedied by the outcome. In legal terms, they must have “standing” to sue. The suit before Kacsmaryk invokes the suffering of women, girls, sex trafficking victims, and aborted fetuses (which it calls babies), but it strains to show how mifepristone affects the actual plaintiffs—medical organizations and doctors who claim neither to have received nor provided an abortion.

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Instead the plaintiffs have alleged an injury so speculative it’s dreamy. Their claim to standing rests on the fact that they sometimes have to treat patients for negative reactions to mifepristone after it has been prescribed by other doctors. In doing so, they may suffer emotional “anguish” if that treatment requires them to remove fetal tissue, and lose out on seeing other patients at the same time. This chain of events is only set off by adverse reactions that are, despite what the plaintiffs say, very unlikely: the chance that a patient will be hospitalized after taking mifepristone is at most 0.7 percent, and the risk of sepsis, hemorrhaging, or the need for blood transfusions is even lower. Studies suggest that the drug is less risky than Tylenol and Viagra.

All these problems should tank the lawsuit, but they haven’t stopped Kacsmaryk before. In other cases brought by conservatives, he’s set himself loose from judicial restraints to block liberal policies. Last year he held that the Department of Health and Human Services couldn’t fund Texas organizations that gave birth control to minors without their parents’ consent. The plaintiff in that case was a Christian dad determined to maintain his daughters’ virginity. Even though the man never claimed that his kids had sought out, or received, birth control, Kacsmaryk found he had standing. He reasoned that, among other things, the federal program had deprived the father of the reassurance that his daughters, if they ever tried to get birth control, would be unable to do so.

Plaintiffs can’t usually choose the judge that will hear their case, but a quirk in the Texas court system automatically assigns cases filed in some towns, such as Amarillo, to certain judges, such as Kacsmaryk—a loophole the Justice Department is trying to close. The plaintiffs seem to trust that Kacsmaryk will come through. If he does, right-wing activists will have won another fight to limit the options of pregnant people, because a man in Texas has power he’s willing to abuse.

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