The US Supreme Court agreed on Wednesday to hear two cases regarding access to the drug mifepristone, which is widely prescribed for abortions and miscarriages. The court previously allowed the drug to remain on the market while the cases wound their way through the appellate process in the US Court of Appeals for the Fifth Circuit.
The challenge to the use of mifepristone is led by the American Association of Pro-Life Obstetricians & Gynecologists and other anti-abortion organizations and physicians. The groups contend that the US Food and Drug Administration (FDA) disregarded safety risks in approving mifepristone and amending its restrictions. They assert that the FDA acted unlawfully under the Administrative Procedure Act in approving the drug in 2000, changing the medication’s safety measures in 2016, approving a generic version in 2019 and allowing the drug to be dispensed by mail in 2021.
To prove that the doctors have standing to sue, one element they must demonstrate is that they have suffered or will suffer “injury” from treating mifepristone patients. The plaintiff physicians stated that they oppose being forced to treat women who may experience emergency complications after taking mifepristone. In such cases, they may be required to perform or complete an abortion or may otherwise be required to participate in a process that facilitates abortion. These interventions, the doctors claim, violate their moral beliefs and cause them distress.
The FDA conversely argued that the doctors’ injury claim is overbroad and “limitless.” Counsel for the FDA asserted “that [the petitioners’] logic would allow doctors to challenge firearm laws based on the stress involved with treating gunshot victims.”
In August, the Fifth Circuit Court of Appeals ruled that the organizations and doctors did have standing under Article III of the US Constitution to sue the FDA and that the 2019 and 2020 safety changes likely violated the Administrative Procedure Act. The Supreme Court will now accordingly reconsider whether the petitioners have standing and whether the FDA’s 2016 and 2021 actions “were arbitrary and capricious.”
The Fifth Circuit’s decision followed one from a federal court in Washington State ordering the FDA to maintain the drug’s availability in 17 states and the District of Columbia.
Milfeprestone’s US history started in 1994 when Roussel Uclaf, the French pharmaceutical company that developed mifepristone, donated the US patent rights to a non-profit entity called the Population Council, which then applied for the FDA to approve the medication as part of a two-drug abortion regimen in 1996. The American Association of Pro-Life Obstetricians and Gynecologists previously filed citizen petitions challenging the use of the drug in 2002 and 2019.
Since the US Supreme Court’s 2021 Dobbs v. Jackson Women’s Health Organization decision overturned abortion-rights case Roe v. Wade, activists on both sides have strongly debated the merit and use of the abortion pill. Pro-life groups cited that “surgical intervention” was required in 7.9 percent of the subjects in the American mifepristone trial and 4.5 percent of subjects in the French trials. However, the reproductive rights organization Guttmacher argued that further abortion access restrictions are “likely to exacerbate further existing racist and discriminatory law enforcement practices that target and disproportionately criminalize black, brown and other people of color for their pregnancy outcomes.”
The US Supreme Court will hear the case this term with a decision most likely coming in the summer of 2024.
