The U.S. Supreme Court sided with the FDA on Thursday morning, unanimously ruling to uphold access to abortion pill mifepristone. The case’s plaintiff — the Alliance for Hippocratic Medicine, an anti-abortion physician group — had been challenging mifepristone access ever since the drug was approved by the FDA nearly 25 years ago.
The long-awaited decision quells the anxiety of many in the healthcare world who wondered what it might look like if the Supreme Court sided with the physician group. Many leaders feared that if the top court could overturn mifepristone’s FDA approval, the same could happen to other drugs.
In 2000, the FDA approved mifepristone and misoprostol, two pills that are taken together to terminate a pregnancy, and ruled that these drugs were safe to use through ten weeks gestation. By 2021, more than half of U.S. abortions were performed using these drugs.
The Alliance for Hippocratic Medicine challenged the lawfulness of the branded drug’s 2000 approval, the generic version’s 2019 approval, and the FDA’s 2016 and 2021 actions to modify mifepristone’s conditions of use. The modifications made it easier for Americans to access the drug — by permitting non-physicians like nurse practitioners to prescribe mifepristone, and by allowing the drug to be prescribed without an initial in-person visit during the Covid-19 pandemic.
In Thursday’s ruling, which was handed down by Justice Brett Kavanaugh, the Supreme Court declared that the plaintiff does not have any legal standing to challenge the FDA’s regulation of the drug.
“Here, the plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact. For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions,” Kavanaugh wrote.
The American Medical Association, which represents more than 271,000 physicians, praised the Supreme Court’s ruling.
A statement from the group’s president-elect, Dr. Bobby Mukkamala, pointed out that restricting access to abortion care without justification is proven to result in negative psychological, physical and economic consequences. Data shows that restricting access to abortion can lead to higher rates of maternal morbidity and mortality, with already marginalized populations being affected the most, his statement noted.
“Efforts to second guess the FDA’s scientific judgment and roll back access to mifepristone were based on a sham case that not only lacked standing, but relied on speculative allegations and ideological assertions to undermine decades of rigorous scientific review proving the drug is highly safe and effective for both termination of pregnancy and for medical management of miscarriage,” Dr. Mukkamala wrote.
Another physician leader — Dr. Steve Furr, president of the American Academy of Family Physicians — lauded the Supreme Court’s ruling for maintaining access to mifepristone and preserving the patient-physician relationship.
“Patients must be able to depend on their physicians to make critical decisions about their personal health,” he wrote in a statement. “Physicians must also be able to practice medicine that is informed by their years of medical education, training, experience and available evidence. Regulatory experts must be allowed to ensure the safety and efficacy of drugs without government interference.”
Restricting access to certain treatments would set a dangerous precedent, Dr. Furr added. This would allow the “rigorous drug evaluation process to be circumvented,” his statement noted.
Leaders in the reproductive healthcare space praised the ruling as well. Monica Cepak — CEO of Wisp, which provides sexual and reproductive healthcare — said that ever since the overturn of Roe V. Wade, the continued threat to abortion access and the potential ban of mifepristone has been “extremely daunting,” especially amid an increased demand for medical abortion.
“I’m certain that I’m not just speaking for myself and Wisp, but for our peers in the reproductive health space when I stress the relief felt nationwide following the court’s decision to uphold broad access to the abortion pill,” Cepak stated.
Photo: Fokusiert, Getty Images
