AlfaOlga/istock via Getty Images

SCOTUS votes to uphold FDA’s mifepristone mailing regulations

The ruling upholds access to medication abortions by continuing to allow the FDA’s regulatory approach for distributing the drug without an in-person doctor’s visit.

After months of speculation on the court’s decision, the Supreme Court of the United States (SCOTUS) rejected a lawsuit from anti-abortion activists that challenged the FDA’s regulatory authority regarding mifepristone distribution. This rejection means that pregnant individuals seeking an abortion in states where it is legal will be able to get mifepristone mailed to them without an in-person doctor’s visit.

Although the saga of reproductive health restrictions began with the overturning of Roe v. Wade in the Dobbs v. Jackson SCOTUS decision — which turned abortion rights over to individual states on June 24, 2022 — mifepristone’s FDA approval came under siege in the middle of 2023. On April 7, 2023, a Trump-appointed federal judge, Mathew Kacsmaryk, ruled to the Alliance for Hippocratic Medicine v. United States FDA case, filed on January 13, 2023, with a preliminary injunction that deemed the FDA approval of mifepristone as illegal.

This injunction and a concurrent, directly opposing decision by Judge Thomas O. Rice of the Eastern District of Washington to maintain the availability of the abortion pill across the 17 states and Washington, DC, began a cascade of legal events in the battle for abortion rights, widening the divide between anti-abortion and abortion-accesses advocates.

While multiple ongoing cases threatened access to medication abortions, SCOTUS issued a ruling to uphold the approval of mifepristone pending ongoing cases on April 21, 2023.

Since then, on August 16, 2023, the US Court of Appeals for the Fifth Circuit decided to restrict access to medication abortions, maintaining the drug’s approval but reversing the 2021 non-enforcement decision by the FDA, which allowed the mailing of mifepristone without an in-person doctor’s visit.

Barriers to care presented by this restriction caused the case to be pushed to an even higher court: SCOTUS. In March 2024, SCOTUS heard oral arguments on mifepristone access and medication abortions. At the time, several experts noted that the court seemed skeptical of a nationwide ban; however, advocates on both sides of the aisle have been waiting for the final decision since then.

Today’s decision is considered a win for reproductive rights advocates, as it maintains access to the drug remotely. The court was unanimous in its decision, which was written by Justice Brett Kavanaugh.

“We recognize that many citizens, including the plaintiff doctors here, have sincere concerns about and objections to others using mifepristone and obtaining abortions. But citizens and doctors do not have standing to sue simply because others are allowed to engage in certain activities — at least without the plaintiffs demonstrating how they would be injured by the government’s alleged under-regulation of others.”

Steve Vladeck, CNN Supreme Court analyst and professor at the University of Texas School of Law, told CNN that the decision's rhetoric leaves a door open for other individuals to sue on the matter if they can establish a stronger legal standing; however, Vladeck notes that the current decision will make suing difficult for other plaintiffs.

Next Steps

Dig Deeper on Medical research and development

xtelligent Healthtech Analytics
xtelligent Healthcare Payers
xtelligent Health IT and EHR
xtelligent Healthtech Security
Close