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Left: Justice Neil Gorsuch poses for an official portrait in the East Conference Room of the Supreme Court building on October 7, 2022 in Washington, D.C. (Photo by Alex Wong/Getty Images). Right: Boxes of the drug mifepristone sit on a shelf at the West Alabama Women’s Center in Tuscaloosa, Ala., on March 16, 2022 (AP Photo/Allen G. Breed, File).

The U.S. Supreme Court heard oral arguments in FDA v. Alliance for Hippocratic Medicine on Tuesday — a case centered around a commonly-used abortion drug that threatens widespread consequences for the entire drug industry.

The justices focused nearly the entirety of the proceedings on whether the plaintiffs in the case — a group of anti-abortion doctors who claimed the drug should be taken off the market because of how it affects them, not people who have taken the drug — have an appropriate claim to bring before the judiciary. The plaintiffs’ argument is a novel one, and should the Supreme Court rule in their favor, the decision has potential to affect much more than just abortion pills.

However, the bench did not appear warm to the idea of siding with the doctors in their crusade against the medication, and Justices Neil Gorsuch and Ketanji Brown Jackson emerged as a pair of unlikely bedfellows as they expressed the same overt skepticism about the doctors’ claims against the U.S. Food and Drug Administration (FDA).

A decades-old approval, an unprecedented decision, and broad consequences

The FDA approved mifepristone in 2000; the drug is one part of a two-drug combination used in the U.S. for medication abortions. Misoprostol, the second drug used as part of the regimen, also has uses unrelated to the termination of pregnancy.

At the center of the dispute lies an unprecedented decision by U.S. District Judge Matthew J. Kacsmaryk in which Kacsmaryk, a Donald Trump appointee, single-handedly ordered the FDA to revoke its approval of mifepristone. The ruling was the result of a lawsuit, likely strategically filed for the purpose of reaching Kacsmaryk, by the Alliance for Hippocratic Medicine (AHM) in which it claimed that the FDA’s approval should be revoked because the drug is unsafe.

After a lengthy hearing on the drug’s safety, Kacsmaryk issued the order AHM requested. The Biden administration appealed and argued that allowing a judge to second-guess the FDA’s scientific judgment is dangerous for women. More than 250 members of Congress support the administration’s position, and filed an amicus brief explaining 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 U.S. Court of Appeals for the 5th Circuit ruled on appeal that it was too late for the doctors and medical groups to challenge the 2000 approval of mifepristone, but kept part of Kacsmaryk’s order in place, resulting in decreased access to the drug. The justices will now review both Kacsmaryk’s underlying order and the Fifth Circuit’s decision.

The case has major implications that go far beyond the context of abortion. Should the justices rule to uphold Kacsmaryk’s first-of-its-kind decision to 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.

A key procedural requirement takes center stage

The justices have already dealt with the case on an emergency basis and issued a temporary order that allowed mifepristone to remain widely available while the challenge to its approvals continued. However, Justices Clarence Thomas and Samuel Alito indicated that they would have ruled differently.

The primary legal issue in the case is that of standing — the requirement under Article III of the Constitution that every plaintiff in a justiciable case suffer 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 taken the drug. These doctors argued that their quality of life was harmed because it was “emotionally taxing” for them to treat women who had taken mifepristone to terminate a pregnancy. According to the plaintiff doctors, some of these unfortunate patients suffered “torrential bleeding,” which was upsetting for the doctors to witness. These unwanted emotional consequences are what the doctors claimed was the injury that created their right to sue.

Additionally, they argued that other doctors — although not they themselves — were forced to perform surgical abortions after patients experienced complications from taking mifepristone, and that doing so went against those doctors’ personal beliefs.

Danco, the company that manufactures mifepristone, argued in its brief that if the justices agree that these doctors have standing to sue, it would risk “virtually every government regulation that touches on health or safety.” Not only could doctors argue against approval of every drug, but teachers could challenge regulations that allegedly disrupt their classrooms, for example, and firefighters could upend regulations they claim present fire risks.

Solicitor General Elizabeth Prelogar argued Tuesday that there is a “profound mismatch” between the injury the plaintiff doctors claim and the relief they are asking the justices to provide, and her argument found a particularly receptive audience in Gorsuch and Jackson.

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