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The FDA Should Not Enforce the 5th Circuit’s Indefensible Abortion Pill Decision [1]

['Mark Joseph Stern']

Date: 2023-04-13 16:23:07+00:00

Early Thursday morning, the 5th U.S. Circuit Court of Appeals partially vindicated Judge Matthew Kacsmaryk’s lawless and unprecedented decision attempting to cut off access to mifepristone, the first drug in a medication abortion. Even the 5th Circuit could not defend Kacsmaryk’s attempt to revoke the Food and Drug Administration’s approval of the drug, which it granted in 2000. But the appeals court agreed with him on nearly everything else, imperiling access to abortion in blue states. Thursday’s decision, if enforced to the letter, would radically reduce access to the medication—and put abortion providers under serious threat of federal prosecution under the Comstock Act.

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The FDA, however, has no legal obligation to enforce this ruling, for two reasons. First, and most importantly, the agency has vast discretion not to enforce ostensible violations of the law. It can, and should, simply say that it will not penalize providers who defy the 5th Circuit’s decision—and providers should follow the FDA’s guidance, not the 5th Circuit’s. Second, the FDA is under a competing court order to preserve access to mifepristone in 17 blue states and the District of Columbia. At a bare minimum, the agency should acknowledge that it must pick one order over another. And the choice should be clear; the competing order more explicitly obligates the agency to maintain mifepristone access in most states where abortion remains legal.

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Because the 5th Circuit largely adopts Kacsmaryk’s off-the-wall theory of standing—and because that theory has already been dismantled by experts—there’s no need to dwell on the profound wrongness of the court’s reasoning. The case really should have stopped with a straightforward explanation of why these plaintiffs, a group of anti-abortion doctors, have no standing to challenge mifepristone in court: They say they are injured because they might treat a future patient who is prescribed mifepristone by someone else. That speculation is not nearly enough to give the plaintiffs standing.

But they got lucky: The randomly assigned 5th Circuit panel included Andrew Oldham and Kurt Engelhardt, two of the most extreme Donald Trump appointees in the entire federal judiciary. (The third judge, Catharina Haynes, is a more moderate George W. Bush appointee who would’ve stayed Kacsmaryk’s whole decision.) The ruling was obviously written by Oldham, as it bears all the judge’s rhetorical trademarks. These plaintiffs really could not have hoped for a more favorable judge to adjudicate their case.

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Oldham agreed with Kacsmaryk that the doctors have standing because they assert that they “have had to devote significant time and resources to caring for women experiencing mifepristone’s harmful effects,” and because of the “enormous stress and pressure” physicians face in the “emotionally taxing work” of treating these women. And he held that the doctors’ anti-abortion organization has standing because the “FDA’s actions have frustrated their organizational efforts to educate their members and the public on the effects of mifepristone.”

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The only novel feature of the 5th Circuit’s analysis is that the court admits that the six-year statute of limitations for challenging such an agency action bars an attack on the original approval of mifepristone in 2000. So, instead, the appeals court suspends every FDA approval related to the drug since 2016. Those approvals reduced medication abortion patients’ required trips to the doctor from three to one, and then to zero (by allowing mifepristone to be mailed); allowed a generic version of the drug to be manufactured (thereby lowering costs); increased the period of pregnancy when mifepristone can be prescribed, from 50 days to 70; allowed medical providers other than doctors to prescribe the medication; and eliminated reporting requirements of certain adverse reactions (because 16 years of reporting had proved the drug was safe). The 5th Circuit grants the plaintiffs standing to challenge all those changes because, it asserts, the approvals made the risk of mifepristone’s complications even higher. That analysis extends Kacsmaryk’s already absurd logic to the point of parody.

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Having leapt that hurdle, the 5th Circuit spends less than three pages explaining why the FDA’s gradual reduction of limits on mifepristone were illegal. It agrees with Kacsmaryk that the agency should not have eliminated mandatory reporting of certain adverse events, even though the FDA explained that 16 years of reporting proved the drug was extraordinarily safe and effective. (It’s safer than Tylenol, Viagra, insulin, and most antibiotics.) This move, the court says, renders everything the FDA did around mifepristone from 2016 onward unlawful. And so it orders the agency to bring back all the drug’s bygone restrictions. Although the decision is rather sloppy and vague, in nullifying every FDA action after 2016, the court also appears to overrule the 2019 approval of a generic version. There is, of course, no evidence the generic version is more dangerous than the brand name.

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Then comes the coup de grâce: The court finds that overruling the FDA is especially justified because the Comstock Act ostensibly outlawed the mailing of medication abortion. This notorious 1873 law was designed to preserve traditional sexual morality by giving the government sweeping powers to censor the mail. The act is so impossibly broad that federal courts have consistently interpreted it to encompass only acts that are intended to produce an illegal result. But the 5th Circuit strongly suggests that’s wrong, and that the law criminalizes all “carriage in interstate commerce” of any “drug, medicine, article, or thing” designed “for producing abortion.”

If that’s true, then it lays the groundwork for a federal ban on abortion. All means of abortion invariably go through interstate commerce. Pills must be shipped to providers, even if they are not ultimately mailed to patients. The medical instruments used in procedural abortions must travel across state lines to reach their destination. In a modern economy, it is just inevitable that something designed for abortion will go through interstate commerce. The 5th Circuit appears to think that’s all a federal crime. If it’s right, then the Comstock Act is effectively a 50-state abortion ban.

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The Justice Department will now ask the Supreme Court for an emergency stay on the 5th Circuit’s ruling. The justices will have to respond one way or another, because of the competing orders: A federal judge in Washington state, Thomas Rice, has ordered the agency to continue allowing mifepristone, without the barriers resurrected by the 5th Circuit, in 17 states and D.C. Only the Supreme Court can resolve these mutually exclusive orders. In the meantime, the FDA should announce that it will not impose the barriers revived by the 5th Circuit, resting on its enforcement discretion. The agency has clear authority to say that it will not take any action against medical providers who do not comply with the 5th Circuit’s order. And no matter how the agency responds, doctors still retain clear authority to prescribe mifepristone off-label beyond 50 days of pregnancy.

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Finally, if all else fails, abortion providers can start to prescribe misoprostol-only abortions. Misoprostol is usually the second drug used in medication abortion, but it is also effective on its own—though it causes slightly more complications and discomfort. One irony of this case is that the plaintiffs say they want fewer patients suffering side effects from medication abortion, yet they acknowledge that a mifepristone ban will result in more misoprostol-only abortions, which produce more side effects. (That fact alone should defeat their claim to standing.)

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This whole case is a humiliating mess for the judiciary, and it remains very possible that at least five justices will see that. The 5th Circuit tried to strike a pose of moderation, but it failed badly. If the Supreme Court does not stay its decision, it will have allowed federal judges to overrule the FDA’s expert authority for the first time, permanently undermining the gold standard of drug approval. This case is not just a threat to reproductive autonomy. It is a frontal assault on the entire biotech and pharmaceutical fields’ ability to function with constant, catastrophic interference from unelected judges who will impose their will at any cost.

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[1] Url: https://slate.com/news-and-politics/2023/04/abortion-pill-fifth-circuit-ruling-mifepristone-fda-doctors.html

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