Washington — The Supreme Court said Wednesday it will take up the Biden administration’s bid to maintain access to a widely used abortion pill, marking the first dispute involving abortion that the high court will hear since members of its conservative majority overturned Roe v. Wade last year.
Brought by a group of doctors and medical associations opposed to abortion rights, the outcome of the case could have far-reaching consequences by restricting how the drug mifepristone can be obtained, who can prescribe it and when it can be taken. The court turned away a separate appeal from the organizations that asked the justices to decide the legality of the Food and Drug Administration’s 2000 approval of mifepristone and a generic version of the drug.
The high court intervened in the case during an earlier stage, leaving the availability of mifepristone unchanged until the justices render a final decision, which is expected by the end of June and would have a nationwide impact, even in states where abortion is legal.
In response to the Supreme Court’s decision to take up the case, White House press secretary Karine Jean Pierre said the Biden administration will continue to stand behind the FDA’s approval of mifepristone as safe and effective. She warned that a lower court ruling limiting the drug’s availability, if upheld, “threatens to undermine the FDA’s scientific, independent judgment and would reimpose outdated restrictions on access to safe and effective medication abortion.”
“No woman should be unable to access the health care that she needs,” she said in a statement. “This should not happen in America, period.”
The fight over the abortion pill mifepristone
Allen G. Breed / AP
The legal fight involves steps the FDA has taken in recent years to expand access to mifepristone, which is taken together with a second drug, misoprostol, to terminate an early pregnancy.
The FDA approved the abortion pill in 2000, and relaxed the rules surrounding its use through a series of actions in recent years. In 2016, the agency extended how late into a pregnancy mifepristone could be taken from seven weeks to 10 weeks; reduced the number of in-person visits required from three to one; and expanded the health care providers who can prescribe and dispense the drugs. In 2021, the FDA removed the in-person dispensing requirement entirely, meaning patients could receive mifepristone through the mail.
More than 5 million women seeking to end a pregnancy have taken the drug since its approval by the FDA 23 years ago. The agency has argued that studies show serious adverse events associated with mifepristone are rare. More than half of abortions in the U.S. are medication abortions, according to the Centers for Disease Control and Prevention.
In November 2022, the doctors and groups led by the Alliance for Hippocratic Medicine filed a lawsuit in federal district court in Amarillo, Texas, challenging the FDA’s 2000 approval of mifepristone, as well as its changes starting in 2016.
In a preliminary order issued in April, U.S. District Judge Matthew Kacsmaryk found the medical associations were likely to prevail in their case, and he blocked the FDA’s 2000 approval of mifepristone and all subsequent actions from the agency that made it easier to obtain.
The decision from Kacsmaryk set off a series of rulings from the courts after the Biden administration appealed to the U.S. Court of Appeals for the 5th Circuit. The appeals court first narrowed Kacsmaryk’s order, reinstating mifepristone’s 2000 approval but tightening the rules for its use, after which the Supreme Court put on hold the entirety of his decision.
The 5th Circuit then issued an opinion in August after holding oral arguments, finding that the medical groups’ challenge to the FDA’s 2000 approval of the abortion pill was likely untimely. But the three-judge panel concluded that the agency likely acted unlawfully when it loosened the rules for obtaining mifepristone since 2016, a finding that would limit access to the drug.
The Justice Department and Danco Laboratories, the maker of mifepristone, asked the Supreme Court in September to overturn the 5th Circuit’s decision, which the Biden administration said is unprecedented.
“The Fifth Circuit countermanded a scientific judgment FDA has maintained across multiple administrations; imposed unnecessary restrictions on the distribution of a drug that has been safely used by millions of Americans over more than two decades; and upset reliance interests in a healthcare system that depends on the availability of mifepristone as an alternative to surgical abortion for women who choose to lawfully terminate their early pregnancies,” Solicitor General Elizabeth Prelogar wrote in a petition to the high court.
Prelogar argued that the challengers lack legal standing to sue, since they failed to demonstrate that they would be harmed by the FDA’s decisions over mifepristone’s availability. If the high court were to leave the 5th Circuit’s ruling in place, she warned it would have sweeping ramifications by inviting medical associations to challenge any government action that might “incidentally affect” just one of their member’s practices.
“Pulmonologists could sue the Environmental Protection Agency to challenge regulations that increased (or reduced) air pollution; pediatricians could sue the Department of Agriculture to challenge standards that imperiled (or improved) student nutrition; and emergency room doctors could sue the government to challenge regulations that loosened (or restricted) access to firearms,” Prelogar wrote.
Lawyers with the Alliance Defending Freedom, a conservative legal group representing the abortion rights opponents, urged the Supreme Court to deny review of the 5th Circuit’s ruling, arguing that the FDA is not infallible from having its actions reviewed by the courts.
“[The FDA and Danco] are wrong to insinuate that the lower court’s decision takes mifepristone off the market. It does no such thing,” they told the justices in a filing. “The modest decision below merely restores the common-sense safeguards under which millions of women have taken chemical abortion drugs.”
Supporting the Biden administration and Danco are pharmaceutical companies, more than 250 congressional Democrats and 23 Democratic-led states and the District of Columbia. They warned that if the 5th Circuit’s decision is allowed to take effect, it would not only disrupt access to a widely used method of abortion, but put at risk the regulatory framework for drug approvals.
“Researchers, health care providers, and patients suffering from a range of medical conditions rely on the integrity and stability of the rigorous science-based drug approval process,” Democrats in the Senate and House told the court in a filing. “The specter of precipitous judicial meddling therefore threatens access to life-improving and lifesaving drugs.”
The challenge to mifepristone’s approval and the FDA’s relaxing of rules for its use marked the latest effort from abortion-rights opponents to restrict access to abortion through the courts, even after their watershed victory 18 months ago with Roe’s reversal.
More than a dozen states have enacted near-total bans on abortion following the Supreme Court’s decision, and 15 states restrict access to medication abortion, such as by requiring that the drugs are provided by a physician or prohibiting the use of telemedicine for mediation abortion.
The Biden administration, meanwhile, has sought to make abortion pills more readily available. The FDA in January allowed retail pharmacies to dispense mifepristone, and numerous Democratic-led states have enacted shield laws that protect health care providers who prescribe mifepristone to patients in states with stringent abortion laws.
