Left, front row: U.S. Supreme Court Associate Justice Clarence Thomas, Chief Justice John G. Roberts, Jr., Associate Justice. and Samuel A. Alito, Jr., Back row, left to right: Associate Justice Amy Coney Barrett, Associate Justice Neil M. Gorsuch, and Associate Justice Brett M. Kavanaugh. (photo via Fred Schilling, Collection of the Supreme Court of the United States). Right: Caroline Smith, of Washington, demonstrates against abortion pills outside of the Supreme Court, Friday, April 21, 2023, ahead of an abortion pill announcement by the court in Washington. (AP Photo/Jacquelyn Martin).
The Supreme Court granted review Wednesday in a case with potentially profound consequences for both abortion rights and the future of the pharmaceutical industry — but the justices may have tipped their hands about a rather undramatic outcome.
The Court granted certiorari in FDA v. Alliance for Hippocratic Medicine, in which the Biden administration asked the justices to overturn a conservative appellate court’s ruling against the abortion drug mifepristone.
Last April, a three-judge panel of the U.S. Circuit Court of Appeals for the Fifth Circuit upheld a portion of an unprecedented decision by U.S. District Judge Matthew J. Kacsmaryk that ordered the U.S. Food and Drug Administration’s (FDA) to revoke approval of mifepristone. The pill, which has been approved by the FDA since 2000, is one part of a two-drug combination used in the U.S. for medication abortions; the second drug, misoprostol, can be used on its own, but studies show it is less effective than using both drugs to end an early pregnancy.
Following the Supreme Court’s 2022 ruling in Dobbs v. Jackson Women’s Health Organization obliterating a woman’s right to abortion care nationwide, an anti-abortion organization called Alliance for Hippocratic Medicine (AHM) sued the FDA claiming that the approval of mifepristone should be revoked because the drug is unsafe. Kacsmaryk, an appointee of Donald Trump — under whom the Supreme Court’s ideological balance shifted significantly, allowing the monumental abortion ruling in Dobbs to happen — held a lengthy hearing on the matter. Although the American Medical Association advised that the call for removing mifepristone from the market was “not based on rigorous scientific review and analysis but on speculation and the personal opinions of two physicians,” Kacsmaryk ordered the FDA to revoke its approval.
Kacsmaryk’s ruling did not take immediate effect and the Biden administration appealed, arguing that revoking the drug’s approval would “thwart FDA’s scientific judgment severely harm women, particularly those for whom mifepristone is a medical or practical necessity.” That appeal is what is now before the justices.
The fate of mifepristone and the effect on medication abortion, while significant, are only part of what is at stake in the case.
Far more broad is AHM’s challenge to the FDA’s independent authority to approve drugs. If the justices rule that Kacsmaryk was within his rights to unilaterally demand the FDA roll back a decades-old drug approval, it could set the precedent that other judges could similarly interfere with approval of any and all drugs.
Focusing on Kacsmaryk’s first-of-its-kind order against the FDA, 253 members of Congress explained in an amicus brief that when it authorized the FDA to approve drugs, “it did not invite federal courts to substitute their judgment for the expert conclusions of FDA’s scientists.”
The current Supreme Court has already shown itself to be particularly hostile to federal administrative agencies with Justice Neil Gorsuch often seizing every opportunity to rail against the “administrative state.” A ruling that upholds Kacsmaryk’s authority could mean that any medical professional could challenge FDA regulations on medications ranging from birth control pills to puberty blockers to antidepressants.
However, legal experts have opined that the justices have already indicated that they plan to restrict their ruling in the case such that whatever the outcome, the FDA’s drug-approval authority would not be affected for the long term.
Law professor Steve Vladeck posted that although the Court agreed to take up the mifepristone appeal, the fact that it denied AHM’s cross-petition was “a strong signal” that the ultimate ruling would be limited to the topic of standing, thereby relegating Kacsmaryk’s stunning order against the FDA a moot issue.
In all federal cases challenging a federal policy, a plaintiff must show that they have standing — an actual concrete injury or certain impending injury that goes beyond the mere hypothetical.
The AHM mifepristone plaintiffs are a group of anti-abortion doctors, and not patients who have actually taken the drug. Their proffered standing is that their own quality of life was affected because it was “emotionally taxing” for them to treat women who had taken mifepristone to terminate a pregnancy. According to the doctors, some patients who had taken mifepristone to terminate a pregnancy went on to later suffer “torrential bleeding,” which was upsetting for the doctors to witness. They also argued that other doctors were forced to perform surgical abortions after patients experienced complications from taking mifepristone, and that doing so went against the doctors’ personal beliefs.
Legal analyst Elie Mystal eloquently summed up the nature of plaintiffs’ standing argument in a post Wednesday to X, the social media platform previously known as Twitter:
Again, the standing issue in the mifepristone case –the argument that anti-abortion doctors have the right to challenge a drug’s approval because women who take the drug are too sad and embarrassed to sue in their own capacity– is the dumbest most misogynistic shit imaginable. https://t.co/JhhzupaOQi
— Elie Mystal (@ElieNYC) December 13, 2023
Even the conservative Fifth Circuit appeared to acknowledge deficiencies in the doctors’ standing claim. While that court sided with AHM, it clarified that its holding was meant to be narrow and apply only to mifepristone as “an exceedingly unusual regime.”
By rejecting AHM’s petition as to the FDA’s approval of mifepristone while simultaneously granting Danco Laboratories’ petition, the justices are limiting the scope of the review of the case. If the justices planned to focus on the merits of the FDA approval, they would likely have granted review on both petitions.
The justices have a habit of being unforgiving in matters of standing, even across a range of case types. Overturning Kacsmaryk’s widely-criticized order on the procedural issue of standing would allow the Court’s 6-3 conservative majority to issue a ruling with favorable consequences for both abortion and the independence of administrative agencies without handing the Biden administration an explicit win.
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