Tomorrow the Supreme Court will hear oral argument in two widely anticipated cases involving the abortion pill, FDA v. Alliance for Hippocratic Medicine and Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine. Specifically at issue will be the FDA’s 2016 and 2021 actions that effectively eliminated many of the constraints governing the use of mifepristone, the pill used in medication abortions. Mifepristone is now responsible for most abortions.
The Left predictably goes ballistic whenever the topic of abortion surfaces in court, and tomorrow’s cases are no exception. Yet another full-blown intimidation campaign, waged by the likes of Vox and a sitting U.S. senator, was already in progress at the district court level before the judge had ruled. That was no surprise given both the sordid buildup to and aftermath of the Court’s decision in Dobbs v. Jackson Women’s Health Organization (2022).
The pending appeals do not involve the sweep of issues involved in Dobbs, which implicated wide-ranging questions of legislative capacity to restrict or regulate abortion. But the smaller subset of abortion issues surrounding the pill still bears significant consequences for women and children immediately and for the separation of powers more generally. As in several recent cases before the Court, an unelected federal agency is being called out for acting like Congress on a matter of broad public concern, concentrating power rather than keeping it separate according to constitutional design. While Dobbs put an end to an egregious instance of judicial overreach, the current cases pose questions about executive branch overreach.
The story of that overreach begins with the FDA’s initial approval of mifepristone in 2000. The agency’s decision was dubiously premised on the notion that pregnancy should be labeled a “serious and life-threatening illness” under regulations meant to expedite drug approval for actual life-threatening illnesses and specifically introduced to enable quick approval of HIV/AIDS drugs. But in the process, the FDA imposed numerous safety precautions to protect women.
The agency arbitrarily dropped many of those precautions in 2016, with rule changes that included increasing the maximum gestational age for using mifepristone from seven weeks to ten, allowing non-doctors to prescribe and administer chemical abortions, decreasing the number of in-person doctor’s office visits from three to one, and eliminating the requirement that prescribers report non-fatal adverse events. Dropping the obligation of doctors to report complications eliminated the clearest source of data to judge the pill’s safety and one of the key backstops to ensure safety in the expedited emergency approval regime. The FDA also could not point to any study that independently supported its decision to remove so many safeguards at once. The agency’s conduct was a glaring example of arbitrariness.
In 2021, the FDA, invoking COVID as an excuse for further deregulation of the abortion pill, permanently removed in-person dispensing requirements for the drug and allowed for mail-order abortions. That presented more than one problem. It was arbitrary because the agency had previously abandoned reporting adverse events connected to mifepristone use and once again could not point to any study that independently supported its decision. The FDA was also in direct violation of the Comstock Act. While the Biden administration tried to dodge that statute’s plain language, there is no getting around its ban on sending in the mail any “article or thing designed, adapted, or intended for producing abortion.” (The Office of Legal Counsel produced an opinion in 2022 supporting the administration’s conclusion, but the Court is unlikely to agree with its text-twisting logic.)
The claims against the FDA by medical association members and individually-named doctors in the lower courts included a challenge to the initial 2000 approval of mifepristone, but the Fifth Circuit held that to be time-barred. The Supreme Court denied certiorari on that issue. But challenges by the same plaintiffs to the 2016 and 2021 FDA changes are now before the Court.
A threshold issue in this case will be standing. The FDA and Danco Laboratories, the pharmaceutical distributor, claim that the plaintiffs’ injury was only speculative—that the doctors do not prescribe or use the drug and that their only real disagreement with the FDA is their opposition to abortion generally. The Fifth Circuit rejected that argument and found that the medical association members and individually-named doctors did have standing: They were being forced to participate in abortion against their conscience, with increased risk of consuming their practices’ limited resources to treat women experiencing chemical abortion complications, not to mention being exposed to greater liability and insurance costs. So there is a strong argument for associational and individual standing.
On the substance—and this is easy to miss for anyone who sees only the demagogic reporting on the other side—the plaintiffs are simply asking the Court to allow the same safeguards for women’s health that existed for the first 16 years of mifepristone’s use. The justices are being asked not to blindly defer to the FDA’s arbitrary judgments. Two panels of the Fifth Circuit recognized that the agency was likely pursuing its actions arbitrarily, and a majority of the Supreme Court is likely to agree. They have seen the “abortion distortion” in play before. Long a problem that afflicted judges prior to Dobbs, the Alliance for Hippocratic Medicine cases show that executive branch officials are also susceptible to a similar temptation to disregard text and overreach on a highly controversial topic. And to what end? The FDA is harming women by undoing protections for them.