The Food and Drug Administration, in each of the past three Democratic administrations, has strained toward three goals with regard to the mifepristone-based chemical abortion pill known as RU-486: first, to loosen legal restrictions on the pill’s availability, even at the expense of disregarding federal law and scientific evidence; second, to insulate the FDA’s acts from judicial scrutiny; and third, to take actions at times that would limit political accountability.
Thus, the pill was approved in 2000 by the Clinton administration on the way out the door and fast-tracked on the ludicrous theory that pregnancy is a “serious or life-threatening illness” on par with AIDS, allowing for emergency expedited drug approval. Then, a legal challenge filed with the FDA in 2002 was left unresolved for nearly 14 years (throughout the entirety of the Bush administration) in order to thwart judicial review while the pill expanded its market share, creating facts on the ground. Next, the Obama administration loosened regulatory restrictions in its own final year in 2016, including scaling back reporting requirements for adverse health complications in order to starve challengers of the data with which to question the harms being done in the name of “choice.”
The Biden administration further watered down the safety precautions under cover of the pandemic in 2021, eliminating rules for in-person medical consultations as a Covid emergency rule, after which it declared those changes permanent. Attorney General Merrick Garland claims the authority to allow the pill to be sent through the mail into states where abortion is illegal, and to override laws against prescribing the pill to obtain that illegal end. This is an assertion of preemptive federal authority that not only tramples state law but flies in the face of an explicit federal statute (the Comstock Act, passed in 1873) banning the use of the mail for abortion drugs.
The legal challenge to the FDA’s original approval, while strong on the merits, faced daunting statute-of-limitations problems due to the strategy of delay. That issue fell by the wayside by the time the case reached the Supreme Court, where it was argued Tuesday. Thus, despite breathless press coverage, the central issue before the Court is not a ban on the pill but whether to sustain challenges to the 2016 and 2021 decisions stripping the safety precautions for chemical abortion. The challengers are medical professionals who note the frequency with which women who take the pill — especially in a do-it-yourself home environment with no medical supervision — end up in emergency rooms or in need of further medical attention. The Biden administration, which has claimed the authority to forcibly vaccinate American workers, is hardly a sincere champion of the right to ignore the doctors and treat yourself. It is also not a sincere champion of conscience protections that it now touts as a reason why pro-life health professionals have no injury to litigate. But abortion, as usual, plays by different rules.
The justices focused on whether the challengers have standing to sue. The question is a serious one but also reflects the persistent determination of this administration to evade any accountability when it flagrantly disregards the law. It further reflects the imbalanced nature of the Court’s standing jurisprudence, which as recently as the 2020 June Medical decision allowed abortion doctors to assert the rights of their patients.
Solicitor General Elizabeth Prelogar claimed that the FDA had the right to ignore the Comstock Act, on the theory that “the Comstock provisions don’t fall within FDA’s lane.” She told Justice Samuel Alito:
FDA was not affirmatively approving mailing in violation of Comstock, even if you interpreted it that way. . . . At the very least, I don’t think that it was FDA’s responsibility to consider that, nor could it have permissibly considered that under the statute.
This is a shell game: Garland has previously claimed that states are barred from outlawing chemical abortion because the FDA has approved the pill. Now, Prelogar says that the FDA didn’t even have to conclude that its approval of the pill’s distribution through the mail actually complied with federal law. If she’s right, then the FDA’s approval should be afforded very little weight in displacing state authority to ban a practice that is already illegal under federal law.
The posture of the two cases, FDA v. Alliance Hippocratic Medicine and Danco Laboratories, L.L.C. v. Alliance Hippocratic Medicine, may not lend itself to a conclusive ruling on either the scope of the Comstock Act or the residual state power over the pill’s distribution and use.
The justices may reject the case on standing grounds or issue a narrow ruling. But in addressing the FDA’s effort to undermine patient safety and the administration’s broader contempt for federal law, the Court should do no harm.