Last month, the U.S. Supreme Court heard oral arguments about access to a chemical abortion drug in FDA v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine. This is the first case since Dobbs v. Jackson Women’s Health Organization in 2022 in which the Court has considered the issue of abortion. Since then, fourteen states have enacted legislation prohibiting abortion entirely, while seven more have restricted abortion access. However, chemical abortions still make up over half of all abortions in the United States. A Supreme Court decision in favor of the medical associations and doctors in these cases would restrict the availability of chemical abortion drugs across the country and, ergo, further reduce access to abortion. However, such an outcome seems somewhat unlikely after hearing the Justices’ questions in oral argument.
The cases center around the drug mifepristone, which blocks a hormone called progesterone, causing the lining of the uterus to break down and depriving a baby of nutrients while developing in the womb. Mifepristone is paired with misoprostol, which is subsequently taken to induce contractions and expel the unborn child from the mother’s womb.
The FDA initially approved the two-drug regimen in 2000 with several safeguards that limited its use. Only licensed doctors who could diagnose ectopic pregnancies and determine gestational age were allowed to prescribe the abortion drugs, the drugs could only be used during the first seven weeks of pregnancy, and doctors were required to oversee the administration of each drug and to check for complications in three required in-person visits.
However, in 2016, the FDA removed many of these safeguards, allowing non-physician healthcare providers to prescribe the drugs, expanding the use of the drugs through the tenth week of pregnancy, and requiring only one in-person visit to a doctor. The requirement that prescribers report nonfatal complications, such as hospitalizations and blood transfusions, was also removed. This trend continued during the COVID-19 pandemic in 2021, when the FDA permanently removed the in-person visit requirement, allowing the drugs to be prescribed by non-doctors virtually and mailed to women.
In 2022, medical associations and individual doctors filed a lawsuit in federal court to challenge the FDA’s expanding access to the drug. They argued that the FDA’s 2016 and 2021 rule changes were based on incomplete and unreliable data, endangered the health and safety of women and girls, and would require doctors to violate their religious and moral beliefs by forcing them to be complicit in completing elective abortions in emergencies.
In April 2023, a federal district court judge suspended the FDA’s rule changes due to the flawed decision-making process. The FDA (and the drug manufacturer Danco Laboratories, which intervened) appealed to the Fifth Circuit, and it upheld the decision of the federal trial court, ruling that the FDA must restore the pre-2016 safety standards and disallow abortion drugs from being shipped by mail. The FDA and Danco then petitioned the U.S. Supreme Court to consider the cases last fall. The Court granted cert, placed the Fifth Circuit’s ruling on hold, and heard oral arguments last month.
There are three issues before the Court, but the Court’s questions focused mainly on the first issue of standing. Under Supreme Court precedent, Article III of the Constitution requires a plaintiff to have “standing” for a federal court to hear his or her case. The plaintiff can meet this standing requirement by proving that 1) he or she personally suffered or will imminently suffer an injury, 2) that the defendant caused the injury, and 3) that a court decision in the plaintiff’s favor will redress the injury. The medical associations and doctors must establish that they have standing for the Supreme Court even to consider the merits of their cases: the second issue of whether the FDA’s rule changes were valid, and the third issue related to whether the Fifth Circuit’s relief was appropriate.
U.S. Solicitor General Elizabeth Prelogar represented the FDA, arguing that the doctors do not have standing because they do not prescribe the drugs themselves, and the FDA’s 2016 and 2021 rule changes do not require anything of them. Further, the medical associations’ and doctors’ alleged injury is not imminent; rather, it is a hypothetical possibility that “rests on a long chain of remote contingencies.” This is evidenced by the fact that complications from the two-drug regimen are rare, and none of the doctors in this case could point to a single example where they had to treat a woman who suffered from such complications. The SG also argued that it is unnecessary to roll back the FDA’s rule changes to prevent the plaintiffs’ asserted injuries because federal law, namely the Church Amendments, already provides individual exemptions to doctors with religious conscience objections so that they do not have to participate in abortion-related treatment. Several of the Justices seemed convinced by the SG’s arguments, though Justice Alito did question whether any conceivable party would have standing to challenge the FDA’s rule changes. The SG’s answer in the negative led to the Justice’s incredulous response, “[then] the American people have no remedy?” Justice Alito was also willing to address the merits issues, asking counsel representing Danco if “the FDA is infallible” and asking (along with Justice Thomas) whether mailing medications is legal under the Comstock Act.
Erin Hawley, Senior Counsel at Alliance Defending Freedom, represented the medical associations and doctors, arguing that there is standing in these cases because the FDA’s abandonment of the two-drug regimen’s original safety standards increases the risk of complications. “The FDA concedes between 2.9 and 4.6 percent of women will end up in the emergency room,” with many needing surgical intervention. This “substantial risk” that the doctors must complete an elective abortion is doctors’ proof of injury for standing. Requiring them to provide or be complicit in care they “find morally and ethically objectionable” violates their religious and moral beliefs. Treating patients with complications from medication abortions would also cause them “mental, emotional, and spiritual distress” and require them to “divert time and resources” away from their regular practice of assisting patients with labor and delivery. A few of the Justices were skeptical of these arguments, with Justice Barrett seeming to doubt the doctors’ story of participating in abortion-related treatment and Justice Kagan calling Hawley’s theory of standing “very probabilistic.” Justice Jackson questioned Hawley on whether the federal law conscience exemptions are a more appropriate remedy than challenging the FDA’s rule changes, essentially “seeking an order preventing anyone from having access to these drugs at all.”
Mifepristone remains widely accessible while the Court decides these cases, and an opinion is likely to be released in June or July. However, given the Court’s focus on standing and the minimal attention paid to the merits of the case, it is unlikely that this case will result in access to chemical abortion drugs being restricted.
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