On Tuesday, the U.S. Supreme Court heard oral arguments in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, along withDanco Laboratories v. Alliance for Hippocratic Medicine, regarding the FDA’s removal of critical safeguards allowing near-unfettered access to the chemical abortion drug Mifepristone, half of a two-drug protocol used to end pregnancies in early stages.
The case centers around the FDA’s sweeping deregulation of Mifepristone in 2016 and 2021. These changes included allowing the drug to be used through the 10th week of pregnancy, rather than only through the 7th week, allowing healthcare providers who are not physicians to prescribe the drugs, and allowing the drug to be prescribed through telehealth appointments and sent through the mail. The FDA made these changes despite the drug’s questionable safety record.
The Alliance for Hippocratic Medicine (AHM), a group of pro-life doctors, argues the FDA’s actions in 2016 and 2021 were “unlawful” and state that “all six judges that have opined on the merits of this case” in the district court and in the appeals court “have agreed.” The district court ruled the FDA’s actions were “arbitrary and capricious” and blocked the FDA’s 2000 approval of the drug and all its regulatory changes. However, the Appeals Court ruled that it was too late for AHM to challenge the FDA’s approval and kept the drug on the market but upheld the injunction against the FDA’s more recent changes.
The case raises questions in three areas:
1. Whether the AHM has Article III standing to challenge the FDA’s actions on behalf of a member who may be injured at some future time by those actions;
2. Whether the FDA’s actions were “arbitrary and capricious;” and
3. Whether the lower courts erred in ordering a preliminary injunction of FDA’s 2016 and 2021 actions based on the court’s review of an incomplete administrative record.
U.S. Solicitor General Elizabeth Prelogar argued on behalf of the Biden administration that the FDA deregulated Mifepristone based on its scientific judgment that the drug was safe. She also argued that the AHM did not have standing to bring the case because the doctors do not prescribe Mifepristone and therefore are not “regulated in any relevant way under FDA’s decisions here” and “stand at a far distance from the upstream regulatory action they are challenging.”
However, attorney Erin Hawley argued on behalf of AHM that by its own admission the FDA made regulatory changes to Mifepristone with inadequate data, which violates the Administrative Procedure Act. On the issue of standing, in which the Justices questioned throughout the 90-minute hearing, Hawley stated the evidence satisfies Article III requirements.
“Article III is satisfied here because one, the FDA relies on OB hospitalists to care for women harmed by abortion drugs. Two, the FDA concedes that between 2.9 and 4.6 percent of women will end up in the emergency room. And three, the FDA acknowledges that women are even more likely to need surgical intervention and other medical care without an in-person visit.”
The Justices focused their questions on who has standing to bring this case, whether conscious protections for doctors already apply, and how to appropriately tailor a remedy.
While Justices Neil Gorsuch and Amy Coney Barrett seemed skeptical that AHM had satisfied standing under Article III, both Justices Clarence Thomas and Samuel Alito were skeptical of the government’s argument that people not regulated by the FDA have no standing at all.
Justice Alito stated, “Your argument here is that even if the FDA acted unlawfully, nobody can challenge that in court?”
Prelogar essentially said “no,” while noting there are too many intervening events and independent decisions for a third-party to raise a case and that AHM had not “come within 100 miles” or proving “cognizable” harm that justifies an injunction against the FDA’s decisions.
To this Hawley stated in her opening argument, “Doctors will be forced to manage abortion drug harm is not a bug in the FDA system, but part of its very design. Ruling against respondents standing here would allow federal agencies to conscript non-regulated parties into violating their consciences and suffering other harm without judicial recourse.”
Several Justices asked how conscious protections may apply in this case. Prelogar argued that conscious protections are already in place for doctors who object to treating women in the abortion process. However, Hawley noted that the “emergency nature” of treating a hemorrhaging woman leaves doctors not knowing whether they are treating a miscarriage or an elective abortion until they are scrubbed in and with the patient.
“What harms our doctors…is completing an…elective abortion,” stated Hawley.
Justice Elena Kagan asked Hawley about how the FDA’s actions connect to AHM’s conscious injuries.
Hawley noted that AHM doctors saw a measurable increase in emergency room visits from “abortion drug harm.”
While Justice Alito questioned whether the FDA had adequately studied the frequency in emergency room visits among women who took Mifepristone, attorney Jessica Ellsworth, arguing on behalf of Danco Laboratories (which manufactures Mifepristone), stated judges should not question the FDA’s decision-making.
Ellsworth stated, “…judges … are not experts in statistics. They are not experts in the methodology used for scientific studies for clinical trials…and courts are just not in a position to parse through and second-guess that.”
On the topic of a remedy, both Justices Gorsuch and Ketanji Brown Jackson weighed in on how broad the remedy should be to satisfy the case. Justice Gorsuch noted that there is just a “handful” of doctors bringing this lawsuit and stated that the court’s role is to provide “equitable remedies” to the “plaintiff’s asserted injuries and to go no further.”
Justice Gorsuch also noted that during President Franklin Roosevelt’s 12-year administration that there were no universal injunctions issued by the courts, yet in the last four years there have been “something like 60” orders.
Justice Gorsuch stated, “Recently…we’ve had what one might call a rash of universal injunctions of vacaturs. And this case seems like a prime example of turning a small lawsuit into a nationwide legislative assembly on an FDA rule or any other federal action.” Justice Gorsuch asked Hawley to address this issue.
Hawley replied, “[The doctors’] only availability for relief is if the Court does something to the FDA’s order or regulation at issue, otherwise those parties are simply out of luck and that’s inconsistent with equity.”
The Supreme Court will rule by the end of June. The case may well be decided on standing. If there is no standing to bring this cause of action, then the case will be dismissed. Other plaintiffs could then mount a challenge if they can show a direct injury traceable to the FDA’s regulatory actions.
Liberty Counsel filed an amicus brief to the U.S. Supreme Court in the case on behalf of the Frederick Douglass Foundation and the National Hispanic Christian Leadership Conference, arguing how Mifepristone has become a “tool of modern-day eugenics” to inexpensively abort millions of unborn lives through widespread abortion.
Liberty Counsel Founder and Chairman Mat Staver said, “The FDA should no longer be allowed to circumvent safety laws to allow a eugenic drug to destroy innocent children and harm women. Chemical abortions are never safe and harm women and kill children.”
