The important thing to know about a Texas court’s nationwide ban of the drug mifepristone is that it’s based on a lie. Well, to be more precise, it’s based on a whole series of lies, but one lie in particular stands out from the others … a Big Lie, if you will. That lie is about the approval process for the drug, which has been on the market since 1988 and is offered for sale in more than 80 countries.
The plaintiffs, a consortium of anti-choice groups that incorporated in Amarillo, Texas after anti-choice activist Matthew Kacsmaryk was confirmed to the only federal court in the district, stake their claims on the fact that the FDA approved mifepristone in 2000 under an emergency protocol known as Subpart H. This protocol allows lifesaving drugs to reach the market sooner and has mostly been used to fast-track AIDS drugs. In reality, mifepristone went through four years of rigorous examination before its approval. But in response to political pressure, the FDA used Subpart H to impose additional dispensing protocols known as Risk Evaluation and Mitigation Strategies or REMS.
Back in March, when the parties made their case to Judge Kacsmaryk for injunctive relief, Slate legal writer Mark Joseph Stern observed that, not only were the plaintiffs lying about the approval process, but that Kacsmaryk seemed to accept their false version of events:
This entire argument is built upon a lie. The FDA did not fast-track mifepristone in 2000. Rather, the agency took more than four years to greenlight the drug, doing so only after extensive (and arguably superfluous) examination of its (very minor) risks. When the FDA did finally approve the use of mifepristone, after an unusually thorough review, however, it imposed heightened restrictions on its distribution. It was theseextra barriers to mifepristone access that were set up through a process known as accelerated approval. The plaintiffs here exploit confusion about these procedural details to peddle the false narrative that the agency recklessly hastened review of mifepristone. It is an extremely ominous sign that Kacsmaryk appeared to agree with their false history.
And that turned out to be exactly what happened when Kacsmaryk dropped his ruling on Good Friday, a love letter to the anti-choice loons that put him on the federal bench to do just what he did. Reasoning that Subpart H is reserved for “serious or life-threatening ‘conditions,’” he ruled that it was inappropriate to use for a drug that ends pregnancy, since “Pregnancy is a normal physiological state most women experience one or more times during their childbearing years — a natural process essential to perpetuating human life.”
It’s an offensively stupid argument, in an opinion chock full of offensively stupid arguments and outright lies about the dangerousness of the drug, which has almost no risk of side effects. For instance, Kacsmaryk presents a bevy of reasons that the six-year statute of limitations on FDA challenges does not apply. Perhaps the government ignored the plaintiff’s administrative challenges (it did not); perhaps the REMS modification in 2016 or the approval of a generic version of the drug in 2021 restarted the clock; perhaps any administrative challenge would have been futile; or maybe you can ignore the plain meaning of the law under the doctrine of equitable tolling, AKA “vibes, man.” In any case, Kacsmaryk deems it wholly appropriate for him to “stay” the FDA’s 23-year-old approval of the drug, making it a dicey proposition for manufacturers to keep selling it.
And that’s not the craziest part! The court relies on the Comstock Act of 1873, a law that prohibits using the mail to transport “Every obscene, lewd, lascivious, indecent, filthy or vile article, matter, thing, device, or substance.” Clearly this violates the First Amendment, which is why it’s never enforced, despite remaining on the books. The law has a provision that bans using the mail to send “every article or thing designed, adapted, or intended for producing abortion, or for any indecent or immoral use,” which birth control advocate Margaret Sanger successfully challenged in a 1936 case involving the importation of an early form of diaphragms.
Nevertheless, Kacsmaryk expresses astonishment that none of the parties in this case cite the Comstock Act as a reason to challenge the FDA’s approval of dispensing mifepristone by mail, and he cites a 1915 case as standing for the proposition that, in 2023, the US has “a national policy of discountenancing abortion as inimical to the national life.” This requires ignoring the Food and Drug Administration Amendments Act of 2007 (“FDAAA”), which Congress enacted expressly to permit the mail-order distribution of mifepristone. But ignoring inconvenient factual and legal realities is Matty K’s specialty!
He even sneaks in a passage about fetal personhood, musing that perhaps fetuses have standing to sue:
Parenthetically, said “individual justice” and “irreparable injury” analysis also arguably applies to the unborn humans extinguished by mifepristone — especially in the post-Dobbs era. [And then he cites to an amicus brief filed in Dobbs by anti-abortion activists saying] (“Nothing in the Constitution or in our Nation’s legal traditions authorizes the Court to adopt [the] theory of life” that States are required “to regard a fetus as lacking even the most basic human right — to live — at least until an arbitrary point in a pregnancy has passed.”)
There is so much that’s gross about this opinion — from excoriating the defendant for using the “unscientific” term “fetus” instead of “unborn child,” to speculating that women would be better off having to have surgical abortions than taking a pill and experiencing an afternoon of cramping. We couldn’t get it all in here if we tried, although Robyn did a great job over the weekend.
But let’s talk instead about the competing order from Judge Thomas Rice in the Eastern District of Washington which came out at roughly the same time last week. Because the FDA is still tinkering with that mifepristone REMS, and so 17 states plus DC sued to stop the government from enacting even more restrictions on distribution. So on Friday night, Judge Rice granted an injunction block the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. § 355-1 in Plaintiff States.”
And that puts the FDA in a weird place, because WTF is even happening right now? Judge Kacsmaryk’s order, which goes into effect this Friday if it’s not blocked by a higher court, purports not to be a nationwide injunction, but rather a stay of the FDA’s 23-year-old approval under Section 705 of the Administrative Procedure Act (5 U.S.C. § 705). This law which allows courts to “postpone the effective date of an agency action or to preserve status or rights pending conclusion of the review proceedings.” But perhaps sensing the glaring defects of his ruling, Kacsmaryk wrote: “If the Fifth Circuit reverses this Court’s Section 705 analysis, the Court clarifies that it alternatively would have ordered Defendants to suspend the chemical abortion approval and all subsequent challenged actions related to that approval until the Court can render a decision on the merits.”
The government has appealed to the Fifth Circuit, which is a nightmare lineup, stacked with Trump appointees. It has not appealed the Washington decision, and, as we discussed in depth on the Opening Arguments podcast (shameless plug alert!), there is a universe in which both orders can coexist. The FDA could colorably argue that the Washington order blocks it from taking any enforcement action against mifepristone suppliers, but that’s not a longterm solution. And unfortunately, the Fifth Circuit and the Supreme Court have shown themselves remarkably willing to countenance the most vile, illegal arguments in an effort to ban abortion.
And Lemon, it’s only Monday.
[Slate / Alliance for Hippocratic Medicine v. FDA, docket via Court Listener / State of Washington v. FDA, docket via Court Listener]
Catch Liz Dye on Opening Arguments podcast.
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