Some of the Republican-appointed members of the Supreme Court on Tuesday expressed doubts about the standing of plaintiffs seeking to restrict access to the abortion pill, an encouraging sign for the Biden administration as it seeks to maintain broad access to the medication.

The Biden administration appealed a lower court’s ruling that would limit how the medication, known as mifepristone, is prescribed and distributed, such as by mail or online orders. Four medical associations and four physicians who oppose abortion brought the challenge to the drug in Texas.

Two cases were weighed in a consolidated format, Food and Drug Administration v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine. The arguments took place less than two years after the high court ruled 6-3 in Dobbs v. Jackson Women’s Health Organization to overturn the landmark Roe v. Wade decision, allowing states to impose laws restricting access to abortion procedures.

Abortion is illegal in 14 states, but abortion pills have remained widely available across the nation.

Mifepristone was approved by the FDA in 2000 and has been defended by the agency as safe and effective. But anti-abortion advocates have said the drug is not safe and that the FDA didn’t sufficiently study it before approval.

The plaintiffs who sued are seeking a high court decision that would roll back actions the FDA has taken since 2016 to make the pills more accessible, including regulations on allowing mail delivery, pharmacy dispensing, and online ordering of the drug. 

Danco Laboratories, the maker of mifepristone, is arguing alongside the FDA to keep these accessibility changes in place.

Roberts tees up question on ‘standing’ theory

Chief Justice John Roberts asked Justice Department Solicitor General Elizabeth Prelogar about the theory of legal “standing,” which would allow some people to bring a lawsuit like the one at the center of the case if there is a statistical likelihood that they would face the requisite injury to bring the suit.

“Is there a number of which your argument would change the significant number of consequences — a higher likelihood of an emergency room visit? Doctors who spend more time in the emergency room at some point. Does this analysis lead to the other result?” Roberts asked Prelogar.

Prelogar argued that the government does not agree with the theory.

“Obviously the FDA is not requiring them to do or refrain from doing anything,” Prelogar said. “They aren’t required to treat women who take mifepristone. FDA is not directing the women who take the drug to go seek out care from these specific doctors, and so they stand at a far distance from the upstream regulatory action they’re challenging.”

Alito and Thomas invoke Comstock Act, ask who can sue the FDA

Justice Samuel Alito, the author of the Dobbs decision, raised concerns that the mail ordering of mifepristone may be linked to higher instances of emergency room visits, as prior studies have indicated.

Alito also questioned whether the government is arguing that no one can sue the FDA if it were to have violated the law.

“So your argument is that it doesn’t matter if the FDA flagrantly violated the law and didn’t do what it should have done, endangering the health of women? It’s just too bad — nobody can sue in court,” Alito suggested.

Prelogar responded that “drug sponsors themselves remain responsible at all times.”

“We have a tort system in this country, and that can help ensure that if there are safety problems that come to pass, the sponsors will take action in reaction to that,” Prelogar said. “So if the premise here is that unsafe drugs could somehow remain on the market, I think that that’s incorrect.”

Justice Clarence Thomas, another member who formed the Dobbs majority, bought up the Comstock Act of 1873, which disallows sending contraceptives through the mail, in questions for Danco: “How do you respond to an argument that mailing medication abortion is a crime under the Comstock Act?”

“We agree very much with the government that FDA’s charge under the Food, Drug, and Cosmetic Act is limited to looking at safety and efficacy considerations. That’s true for new drug approvals,” said Jessica Ellsworth, an attorney for Danco.

Jackson: Are there ‘concerns’ with judges parsing scientific studies?

Justice Ketanji Brown Jackson, the newest justice appointed by President Joe Biden, asked Danco’s attorney if judges should be parsing medical and scientific studies.

Ellsworth responded that the pharmaceutical industry has expressed “significant concerns” over this sort of judicial review as it may threaten the FDA’s gold standard drug approval process.

Judges are “not experts in statistics,” Ellsworth added.

Gorsuch cautions turning suit into ‘nationwide legislative assembly’

Justice Neil Gorsuch, who also was part of the 6-3 decision in Dobbs, raised a line of questioning from Jackson toward Erin Hawley, who represents groups claiming harm by the FDA’s expansion of abortion pill access.

Gorsuch pondered why relief in this case could not be limited to the doctors claiming conscience injury, rather than a broad change to the entire nation’s access to medication.

“And this case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an FDA rule or any other government actions,” Gorsuch said. “Why can’t the court specify that this relief runs to precisely the parties before the court as opposed to looking to the agency in general and saying, ‘Agency, you can’t do this anywhere’?”

Thomas has doubts about injury to plaintiff doctors

Hawley, who is married to Sen. Josh Hawley (R-MO), later faced some doubts from Thomas over claims that the group she representing actually experienced harm, asking her how the “diverted time and resources” by the Alliance for Hippocratic Medicine “isn’t just the cost of litigating and pursuing this litigation.”

Hawley said there is also “noneconomic” harm, but Thomas still appeared skeptical of the stated harms, saying that claims of injury from pursuing litigation is “easy to manufacture.”

Arguments in the cases were ongoing as of 11:40 a.m. Protesters were gathered outside of the high court on Tuesday, some opposing limiting access to mifepristone and others encouraging the plaintiffs in their pursuit of a favorable ruling.

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A decision by the Supreme Court is expected by the end of June.

This is a developing story and will be updated.