The Supreme Court on Tuesday is poised to consider whether to restrict access to the abortion pill as President Joe Biden's administration fights to maintain broad access to the medication in a major case that thrusts reproductive rights back on the agenda of the justices in a presidential election year.
Arguments are set for 10 a.m. ET in the Biden administration's appeal of a lower court's ruling that would limit how the medication, called mifepristone, is prescribed and distributed. Four medical associations and four doctors who oppose abortion brought the challenge to mifepristone in Texas.
The Food and Drug Administration's (FDA) regulatory changes at risk in the case include allowing for medication abortions at up to 10 weeks of pregnancy instead of seven, and for mail delivery of the drug without a woman first seeing a clinician in-person.
The Supreme Court, which has a 6-3 conservative majority, in 2022 overturned its 1973 Roe v. Wade precedent that had recognized a constitutional right to abortion, prompting numerous states to enact Republican-backed measures banning or sharply restricting the procedure. Since then, medication abortion has become the most common method of ending pregnancies in the United States, now accounting for more than 60% of abortions.
The justices are reviewing an August decision by the New Orleans-based 5th U.S. Circuit Court of Appeals that faulted the FDA's decisions in 2016 and 2021 to ease access to mifepristone. The case could put at risk the regulatory authority of the FDA over drug safety.
Mifepristone is taken with another drug called misoprostol to perform medication abortions.
The FDA gave mifepristone regulatory approval in 2000. It has said that after decades of use by millions of women in the United States and around the world, mifepristone has proven "extremely safe," and that "study after study" has shown that "serious adverse events are exceedingly rare."
The plaintiffs, led by the Alliance for Hippocratic Medicine, contend that the FDA acted contrary to its mandate to ensure medications are safe in easing the restrictions on mifepristone, violating a federal law governing the actions of regulatory agencies.
The justices are also tasked with determining whether the plaintiffs had the proper legal standing to bring the litigation, which requires that they show that they have been harmed in a way that can be traced to the FDA.
The plaintiffs have said their member doctors will be forced to violate their consciences because they will "often be called upon to treat abortion-drug complications" in emergency settings due to what they call the FDA's unlawful actions.
The Justice Department has said these claimed harms rely on an impermissibly speculative chain of events - that other doctors would provide mifepristone to women who then experience a rare emergency and end up in the medical care of these plaintiffs. Nor can the plaintiffs who chose to practice emergency medicine claim to be injured "whenever they are presented with patients in need of care," it added.
Biden, seeking a second term in office in the Nov. 5 U.S. election, is an outspoken advocate for abortion rights. He and his fellow Democrats have sought to make abortion rights a central theme against Republicans ahead of the election.
The plaintiffs in 2022 challenged the FDA's actions approving and widening access to mifepristone. Texas-based U.S. District Judge Matthew Kacsmaryk broadly sided with them in a 2023 decision that would have effectively pulled the drug off the market, though the 5th Circuit's decision did not go that far.
The 5th Circuit's ruling remains on hold pending the Supreme Court's review. A ruling is expected by the end of June.
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