Supreme Court unanimously rejects mifepristone challenge, preserving abortion pill access

2024-06-13

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来源: FierceHealthcare

"The plaintiffs want FDA to make mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain. Under Article III of the Constitution, a plaintiff ’s desire to make a drug less available for others does not establish standing to sue," Justice Brett Kavanaugh wrote in the court's opinion.

The Supreme Court unanimously sided with the Food and Drug Administration in a case that challenged the availability of mail-order abortion medications and regulatory authority.

In a decision handed down Thursday morning, the top court wrote that the case’s plaintiffs—the Alliance for Hippocratic Medicine, a group of physicians ideologically opposed to providing abortion services—do not have standing to challenge the agency’s regulation.

“The plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact,” Justice Brett Kavanaugh wrote for the court. “For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.”

The ruling settles a legal battle in which the plaintiffs argued against FDA’s ability to expand the use of mifepristone to include mail-order prescriptions over a decade after its initial approval. U.S. District Judge Matthew Kacsmaryk had taken their side in early 2023 and ruled to invalidate the drug’s full approval, with an appeals court later adjusting the restrictions to telehealth and mail-order prescription.

That decision was put on hold pending the Supreme Court’s input. Its decision today reverses the restriction, ensuring that mifepristone will remain available through telehealth and mail orders.

Lawyers from the federal government, mifepristone manufacturer Danco Laboratories and trade groups from the pharmaceutical and healthcare industries had opposed the plaintiffs and the decisions of the lower courts. In briefs and in oral arguments made before the Supreme Court, they warned judiciary intervention could have disastrous impacts on the FDA’s authority to regulate drugs.

Ultimately, the plaintiffs could not show that they were being harmed by the FDA’s regulations, which sunk their case.

Echoing questions and comments from oral arguments, Kavanaugh wrote in the order that the FDA is not forcing individual providers with conscientious objections to abortion to provide services.

“Rather, the plaintiffs want FDA to make mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain,” he wrote. “Under Article III of the Constitution, a plaintiff ’s desire to make a drug less available for others does not establish standing to sue.”

The court also shot down the “several complicated causation theories” the plaintiffs used to establish injury and standing, such as downstream economic injuries.

Justice Clarence Thomas penned a concurring opinion affirming the court’s rejection of the case.

Supporters of individuals’ right to an abortion said they are relieved by the court’s decision. Plan C, one such group, described the ruling as “a minor win on a baseless case that never should have made it past the initial filing. We’re relieved that the court did not take action to further restrict access to mifepristone, a very safe and effective medication that is already overregulated by the [FDA].”

Health and Human Services Secretary Xavier Becerra celebrated the ruling on behalf of the administration and reiterated HHS' intention to expand reproductive health access where able.

"Mifepristone has been used safely and effectively for more than two decades since it was first approved by the FDA, one of our nation’s most critical public health agencies," Becerra said in a statement. "Today, this critical medication remains approved and available."

Bobby Mukkamala, M.D., president elect of the American Medical Association, said in a statement that the "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."

Mukkamala also alluded to "substantial evidence" that "restricting access to needed abortion care without justification carries a psychological, physical, and economic toll."

Mifepristone is used for about two-thirds of abortions in the U.S. Telehealth and mail-order use rose substantially during the COVID-19 pandemic and since the implementation of state-level abortion restrictions after SCOTUS overturned Roe v. Wade in 2022.

The Supreme Court is currently weighing another case related to medical abortion and the Emergency Medical Treatment and Active Labor Act (EMTALA), which requires hospitals to treat patients with life-threatening health emergencies.