The Friday-night ruling by Judge Matthew Kacsmaryk purporting to stay the Food and Drug Administration’s approval of mifepristone for use in early abortions is a travesty — for women’s health care, principles of democracy, notions of judicial impartiality and the rule of law.
Judge Kacsmaryk put his opinion on hold for seven days to allow the government to seek emergency relief, and the federal government has already filed its notice of appeal in the Fifth Circuit. But if the opinion ever goes into effect,the broadest reading of it could render mifepristone unavailable not just in states like Texas but across the country.
At last month’s hearing on this challenge, the plaintiffs could not identify a single case in which another federal judge had issued the sort of order that Judge Kacsmaryk, an appointee of Donald Trump, ultimately issued. Indeed, our legal system does not ordinarily allow a single Federal District Court judge to override an expert agency’s decades-old decision, in this case that a drug is safe and effective — in particular when that drug is as widely used and essential as mifepristone, one of the medications in the two-drug protocol that is now used in over half of the abortions in this country.
The Biden administration should be swift and forcefulin its response to Judge Kacsmaryk’s ruling, using every tool available to highlight the lawlessness of what the judge has done and to limit any damage that may occur.
This case is wildly atypical for a number of reasons. Under well-settled legal principles, the plaintiffs in the case — a coalition of anti-abortion organizations and physicians — do not have the right to be in court asking for this remedy at all. As commentators from across the political spectrum have noted, the plaintiffs lack standing, a core requirement of any lawsuit in federal court.
They are also bringing their challenge far too late. It is clear that the case is not in response to the F.D.A.’s 23-year-old decision to approve mifepristone or the intervening reaffirmations of that decision; rather, it is in response to the Dobbs v. Jackson Women’s Health Organization decision, which last June overturned Roe v. Wade and Planned Parenthood v. Casey. The umbrella organization that is the lead party in this case, the Alliance for Hippocratic Medicine, incorporated itself in Amarillo, Texas — where Judge Kacsmaryk sits — just weeks after Dobbs.
Despite the Dobbs majority’s claim that overruling Roe and Casey would merely return the issue of abortion to the people and the democratic process, these plaintiffs seem driven by a single goal, one that has nothing to do with respecting democratic choices: to render abortion as inaccessible as possible in as much of the country as possible, even in states whose voters have elected to make abortion legal and accessible.
Judge Kacsmaryk’s opinion finds that the plaintiffs are likely to succeed in their argument that permitting the mailing of mifepristone violates the 1873 Comstock Act, which prohibits mailing “every obscene, lewd, lascivious, indecent, filthy or vile article, matter, thing, device or substance,” including “every article or thing designed, adapted or intended for producing abortion.”
Additionally, the opinion’s conclusion — that the approval of mifepristone most likely violated federal standards for drug approval — is based on several reasons that are scientifically baseless and infused with hostility to abortion, including that the F.D.A. failed to consider “the intense psychological trauma and post-traumatic stress women often experience from chemical abortion.”
Much of the opinion is tonally shocking and medically unsound. Rather than using the term “fetus,” it refers exclusively to “unborn children” and “unborn humans.” It describes mifepristone as used to “kill” or “starve” a fetus, rather than end a pregnancy. It accuses the Biden administration of promoting “eugenics” for identifying the harms to families and existing children that flow from women being denied access to wanted abortions.
Depriving women of access to mifepristone, as this decision eventually could do, would have extremely damaging consequences. If they are not able to prescribe mifepristone, some doctors will stop providing medication abortion entirely, leaving surgical abortion as the only option for many individuals seeking abortion care — something that is inaccessible to many Americans, especially those in states with strict anti-abortion laws.
Because this ruling applies to just mifepristone, not misoprostol, the second drug in the two-drug protocol, some doctors will probably continue to prescribe only misoprostol for early abortions. Studies show that misoprostol is safe and effective when used alone to end early pregnancies. But there is also some evidence that it creates worse cramping and other effects when used alone than when paired with mifepristone.
The drug’s long-settled approval is the result of a functioning democratic process: an accountable federal agency, exercising authority delegated to it by Congress, conducted a rigorous review process — one recognized worldwide as the gold standard. The F.D.A. concluded that mifepristone is incredibly safe, and independent research has since confirmed that it issafer, in fact, than Tylenol, penicillin and Viagra.
The enormous stakes make clear why the Biden administration must respond forcefully. The Justice Department voiced its disagreement with the opinion and said it will appeal. The administration is correct to appeal, and if the Fifth Circuit does not rule swiftly, the Justice Department should ask the Supreme Court to intervene. (The case is expected to reach the high court.)
But the White House must recognize that adherence to well-worn norms — for instance, an orderly appeals process — is less consistent with a principled commitment to the rule of law than more aggressive responses to lawlessness. The administration has other tools (in court, within the F.D.A. and in its interactions with the public) for responding to this decision in the meantime, and it should use them.
There was a conflicting ruling on mifepristone on Friday night: A federal district judge in Washington State issued an order prohibiting the F.D.A. from taking any steps to alter the status quo with respect to the availability of mifepristone in a dozen or more mostly blue states (and the District of Columbia), in response to a lawsuit they filed. If both rulings end up going into effect, pending appellate review, the Biden administration has no higher obligation to the opinion from Judge Kacsmaryk than to the Washington State order. It can leave the status quo intact as it works to coordinate its responses to both cases.
If the administrationconcludes that it must abide by the opinion from Judge Kacsmaryk, it should do so while beginning an expedited process of approving the drug again, a process that responds to the purported flaws that he identified with the F.D.A.’s previous approvals.
The administration should also move quickly to facilitate the provision of mifepristone using methods that would not fun afoul of the court’s reading of the Comstock Act. Contrary to the Office of Legal Counsel, this opinion concludes that the Comstock Act encompasses mifepristone. But the Comstock Act is understood to extend to the mail and “common carriers.” If mifepristone distributors and manufacturers were able to create more production facilities in states that protect access to abortion or to transport the product themselves, these methods of provision would not be subject to the Comstock Act.
The administration should also consider taking the position, as some law professors have argued, that the court cannot require the F.D.A. to enforce its decision and that under long-settled principles of administrative law, the agency retains enforcement discretion. Under this reading, mifepristone manufacturers and distributors could continue to produce and sell their products, potentially under F.D.A. guidance explaining the agency’s planned approach to exercise its enforcement discretion.
This lawsuit and this decision paint a chilling picture of how unconstrained corners of the federal judiciary have become and what’s likely to come next in the legal and political fights over abortion. Many abortion opponents in the run-up to Dobbs argued that the problem with Roe v. Wade was that it removed the question of abortion from the democratic process. But the post-Dobbs era has seen abortion opponents only double down on efforts not to let the states or the people decide for themselves but to undermine access to abortion in every state.
Where voters in the post-Dobbs era have been able to make their voices heard, they’ve clearly expressed, as they did last week in Wisconsin, a desire to protect the right to let people make their own choices about pregnancy. The Biden administration must make the case that a principled commitment both to democracy and to reproductive freedom requires forcefully resisting this opinion.
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