Washington — The Biden administration on Tuesday urged the Supreme Court to preserve broad access to a widely used abortion pill, warning that limiting its availability would impose “grave harms” on women seeking medication abortions.
The Justice Department and Danco Laboratories, the maker of the drug mifepristone, submitted filings to the Supreme Court that laid out their arguments for why the justices should reverse a lower court ruling that would roll back a series of actions taken by the Food and Drug Administration since 2016 that made the pill easier to maintain.
Both Danco and the Biden administration defended the FDA’s actions from 2016 and into 2021 as lawful. Those changes included extending how late into a pregnancy mifepristone can be taken from seven weeks to 10 weeks; reducing the number of in-person visits required from three to one; and expanding the health care providers who can prescribe and dispense the drug. Most recently, the FDA said patients could receive mifepristone through the mail.
“The loss of access to mifepristone would be damaging for women and healthcare providers around the nation,” Solicitor General Elizabeth Prelogar, who defends the U.S. government before the Supreme Court, wrote in the brief submitted to the justices. “For many patients, mifepristone is the best method to lawfully terminate their early pregnancies.”
Prelogar said the FDA’s approval of mifepristone in 2000 was based on its scientific judgment that the medication is “safe and effective,” and its subsequent relaxing of rules surrounding the pill’s use was “supported by an exhaustive review of a record including dozens of scientific studies and decades of safe use of mifepristone by millions of women in the United States and around the world.”
“The portions of the district court’s order affirmed by the Fifth Circuit would impose grave harms on the government, mifepristone’s sponsors, women seeking legal medication abortions, and the public,” she wrote.
The abortion pill case
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The justices are set to hear arguments in the dispute brought by a group of anti-abortion rights medical associations and doctors during its current term, but the proceedings have not yet been scheduled. The challengers sued the FDA in November 2022 over its approval of mifepristone more than 20 years earlier, as well as its more recent changes involving the drug’s use, arguing the FDA failed to adequately consider its safety.
The Biden administration has said studies show the rates of serious adverse events associated with mifepristone are low, and the drug has been taken by more than 5 million women seeking to end a pregnancy.
A federal district court judge blocked the 2000 approval of mifepristone and subsequent actions by the FDA, but the U.S. Court of Appeals for the 5th Circuit narrowed the decision in August after determining that the medical groups’ challenge to the drug’s approval was likely untimely. The three-judge panel, though, concluded that the FDA likely acted unlawfully when it loosened the rules for obtaining mifepristone since 2016.
The Supreme Court has intervened in the case once before, leaving the availability of the medication unchanged until it issues a ruling, which is expected by the end of June. A decision by the justices would be felt nationwide, including in states where abortion is legal.
In addition to defending the FDA’s actions, Danco and the Justice Department argued that the medical associations and doctors that brought the lawsuit lack the legal standing to sue. If the justices agree, they could toss out the case for that reason.
Prelogar told the justices that though the medical associations claim their members include hundreds of OB-GYNs and emergency-room doctors, they haven’t pointed to “even a single instance” in which they were required to terminate a pregnancy.
“Their primary theory is that their members could be required to violate their consciences by completing an abortion for a woman who presents in an emergency room with an ongoing pregnancy,” she wrote. “But that hypothetical scenario cannot establish an imminent injury because it rests on a long and speculative chain of contingencies. Indeed, although mifepristone has been on the market for decades, respondents cannot identify even a single case where any of their members has been forced to provide such care.”
Lawyers for Danco, meanwhile, warned that if the Supreme Court agrees with the 5th Circuit that the medical groups have standing to sue, it would pave the way for other medical organizations to challenge “virtually every government regulation that touches on health or safety.”
The appeals court’s ruling also “threatens to destabilize the pharmaceutical industry, which relies both on FDA’s ability to make predictive judgments and on courts not second-guessing those scientific judgments,” they said in their brief.
Medication abortions have become increasingly common and accounted for more than half of all abortions in the U.S. in 2020, according to the Centers for Disease Control. Mifepristone is taken in combination with a second medicine, misoprostol, to terminate a pregnancy through 10 weeks gestation.
