It's been a whirlwind year or so for mifepristone, part of a two-drug regimen commonly prescribed to induce abortions and one whose legal status was thrown into question by an Alliance for Hippocratic Medicine (AHM) lawsuit. But a Supreme Court decision released today puts an end to the uncertainty (for now), ruling that the group did not have standing to bring the case.
"The plaintiffs do not prescribe or use mifepristone. And FDA is not requiring them to do or refrain from doing anything," noted Justice Brett Kavanaugh in the Court's opinion, which was unanimous.
"Rather, the plaintiffs want FDA to make mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain," pointed out Kavanaugh. "Under Article III of the Constitution, a plaintiff's desire to make a drug less available for others does not establish standing to sue. Nor do the plaintiffs' other standing theories suffice. Therefore, the plaintiffs lack standing to challenge FDA's actions."
Mifeprex, a brand-name version of mifepristone, was approved by the Food and Drug Administration (FDA) in 2000. The AHM and four doctors challenged both this initial approval and the FDA's later approval of generic equivalents, as well as the FDA's more recent loosening of rules for their prescription.
In 2023, U.S. District Judge Matthew Kacsmaryk ruled in the group's favor, but the U.S. Court of Appeals for the 5th Circuit only upheld his ruling with regard to the prescription policies, not approval of Mifeprex or its generic equivalents overall. The Biden administration and Mifeprex maker Danco Laboratories appealed the 5th Circuit's ruling, which brought the matter to the Supreme Court case before us today.
"We are relieved the Supreme Court didn't take this bait, but unfortunately we know that this is far from the end of the line," Jennifer Dalven, director of the American Civil Liberties Union's Reproductive Freedom Project, said in a statement. "Although the Court refused to allow these particular people to bring this case, anti-abortion politicians are waiting in the wings to attempt to continue pushing this case before an extremist judge in Texas in an effort to deny people access to medication abortion care."
Some have argued that if the AHM and the specific doctors in this case lack standing to sue, no one will have standing to sue.
"It is not clear that no one else would have standing to challenge FDA's relaxed regulation of mifepristone," wrote Kavanaugh. "But even if no one would have standing, this Court has long rejected that kind of 'if not us, who?' argument as a basis for standing.…Rather, some issues may be left to the political and democratic processes."
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