The Supreme Court on Thursday unanimously ruled an anti-abortion group contesting the Food and Drug Administration’s approval of the abortion pill mifepristone does not have a legal basis to sue, putting an end to a high-profile court battle.
Justices held that the plaintiffs’ “desire to make a drug less available to others” did not give them standing to challenge the FDA’s actions around mifepristone.
“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 in the court’s opinion. “For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.”
The Supreme Court’s decision reverses a lower court ruling that would have limited mifepristone’s availability, and allows access to the drug to remain as it is. That includes recent changes made by the FDA to permit prescriptions via mail and use through 10 weeks of pregnancy.
Abortion still remains banned in states where legislatures have enacted laws following Roe v. Wade’s reversal. And as the Supreme Court decided the case on the basis of standing, it didn’t delve into debates over how the FDA has regulated the drug’s use.
Mifepristone has been approved in the U.S. since 2000, but its place on the market came under threat when the Alliance for Hippocratic Medicine sued the FDA in 2022. The group’s case, which was first heard in a Texas district court, came less than one year after the Supreme Court overturned Roe v. Wade, the landmark 1973 verdict that had granted the constitutional right to an abortion.
Mifepristone is typically taken in combination with another drug called misoprostol for medication abortions. In the two decades since mifepristone’s initial approval, studies have shown it to be safe and effective. Medication abortions have for years accounted for a large share of the abortions conducted in the U.S. — a share that has grown to more than 60% since Roe v. Wade was reversed.
But the Alliance’s challenge, and initial rulings at the district court and appeals court level, put access to mifepristone in jeopardy. They also raised the possibility of judicial intervention in the FDA’s scientific decision-making. Biotechnology industry leaders were outspoken about the risks to drug regulation posed by the case, citing concerns of a precedent for the legal revocation of a drug approval.
Those fears now appear unfounded, as the Supreme Court rejected the plaintiff’s arguments the FDA’s actions had harmed them.
The ruling reflected skepticism justices voiced in March, when the high court heard oral arguments from the Alliance, the Biden Administration and abortion pill manufacturer Danco Laboratories. Then, the Alliance had argued against FDA decisions to expand the drug’s approval between 2016 and 2021. Lawyers for the group claimed there was a subsequent increase in emergency room visits, and cited possible harm to doctors who object to abortion but might be required to treat complications from mifepristone use.
Justices, however, were skeptical, citing existing legal protections for doctors. “Federal law fully protects doctors against being required to provide abortions or other medical treatment against their consciences — and therefore breaks any chain of causation between FDA’s relaxed regulation of mifepristone and any asserted conscience injuries to the doctors,” Kavanaugh wrote in Thursday’s opinion.
The legal battle over mifepristone began when the Alliance sued the FDA for wrongfully approving the medication. Conservative U.S. District Court Judge Matthew Kacsmaryk, who first heard the case, ruled to invalidate the FDA’s approval, sparking appeals and counter-rulings. Soon after Kacsmaryk’s verdict, a judge in Washington ordered the FDA to maintain the pill’s status in 17 Democratic-led states that had sought broader access, for example.
After an appeal from Danco and the Biden administration, the U.S. Court of Appeals for the 5th Circuit partially blocked Kacsmaryk’s decision, determining the Alliance’s challenge came too late to overturn the FDA’s 2000 approval of mifepristone. But the court rolled back the expansions to the drug’s labeling granted by the FDA. The FDA and Danco appealed, sending the case to the Supreme Court, which put the lower court’s decision on temporary hold while it deliberated.
The decision Thursday now reverses the 5th Circuit’s ruling. Justice Clarence Thomas wrote a concurring opinion to Kavanaugh’s.
