Supreme court justices seemed to express skepticism towards arguments by a group of anti-abortion doctors in a case that could reshape the availability of medication abortion and undermine the US Food and Drug Administration’s (FDA) authority.
The supreme court heard oral arguments on Tuesday in Alliance for Hippocratic Medicine v FDA, the first abortion case to reach the supreme court since it overturned Roe v Wade almost two years ago.
The court will decide whether a group of anti-abortion doctors could force the agency to roll back FDA decisions from 2016 and 2021 that expanded access to a common abortion pill, mifepristone. The pill is generally used as part of a two-drug regimen in medication abortions, which account for 63% of all US abortions.
The justices will probably issue a decision by summer 2024, just months ahead of the US election – in which abortion is expected to be a major issue.
Here are some key takeaways from Tuesday’s hearing:
Even conservative justices expressed skepticism
Conservative justices on the court hold a 6-3 majority. So, while all of the court’s liberal members appeared plainly dubious of the anti-abortion doctors’ claims, at least two conservatives must join them to avoid a decision in favor of anti-abortion doctors.
Much of the argument focused on standing, or whether doctors had the right to sue in the first place, and whether the proposed remedy – rolling back the FDA’s authority to change how a drug is prescribed – went far beyond what was necessary to protect a small group of doctors who can already invoke federal conscience protections if they don’t want to provide abortion care in cases of exceedingly rare complications from mifepristone.
Justice Neil Gorsuch, one of the court’s conservatives, said he was uncertain why the best course of action was to roll back the FDA’s decision. Was throwing out FDA rules the equivalent of, “turning a small lawsuit into a nationwide legislative assembly on an FDA rule, or any other federal government action?”
Justice Amy Coney Barrett also spent a significant amount of time confirming that federal conscience laws already protect anti-abortion doctors.
“So I just want to be clear, the federal government’s position is that ... such doctors would have recourse to the conscience protections of federal law?” she asked the US solicitor general, Elizabeth Prelogar, who represented the FDA.
Similarly, Justice Brett Kavanaugh sought reassurance. “Under federal law, no doctors can be forced against their consciences to perform or assist in an abortion, correct?” he asked Prelogar, who represented the FDA.
Prelogar said that was correct, and that the government believed conscience laws provide “broad coverage here”.
The court’s liberal justices also appeared dubious, with Sonia Sotomayor, Elena Kagan and Ketanji Brown Jackson – the members of the court’s liberal wing – questioning the foundations of the case.
Kagan asked Erin Hawley, the attorney for the Alliance for Hippocratic Medicine, whether she believed that the injuries she is “trying to prove” could be “traceable to the 2016 and 2021 actions you’re challenging … [that] these incidents are caused by whatever incremental increase in risk there is from the 2016 and 2021 actions”. Hawley told Kagan that the 2016 and 2021 actions, which among other things allowed mifepristone to be prescribed via telehealth and delivered by mail, “increased the risk of harm”. The FDA has found no significant safety concerns related to the changes.
Jackson then questioned why doctors needed a remedy as broad as undermining the FDA’s authority and forcing a rollback of their evaluations.
The case has a “significant mismatch” Jackson said, “between the claimed injury and the remedy that’s being sought ... They’re saying, ‘Because we object to being forced to participate in this procedure, we’re seeking an order preventing anyone from having access to these drugs at all.’” Jackson said she was trying to understand “how they could possibly be entitled to that, given the injury that they have alleged.”
Oral arguments underscored the fears of the pharmaceutical industry
Continually evaluating the safety and efficacy of a medication, and adjusting its regulations based on that evidence, are part of the FDA’s core duties.
The pharmaceutical industry considers this case an existential threat, because if a court can roll back evidence-based prescribing changes, what stops judges from parsing science from the bench, even when they have no qualifications to do so?
Two separate exchanges highlighted these fears. First, Justice Samuel Alito, a conservative, asked why the agency didn’t provide a more comprehensive comment on increased emergency room visits from prescriptions of mifepristone via telehealth, which have been permitted by the FDA since 2021.
“The increase in ER visits is just of no consequence? It doesn’t even merit some comment?” Alito asked Prelogar.
To researchers, it was an obvious example of a proxy measure: emergency room visits might indicate the possibility of adverse events, but may also indicate only a woman seeking reassurance, particularly in connection with a drug like mifepristone which induces bleeding. This is exactly the kind of complicated parsing the FDA considers every day when looking at studies on the safety and efficacy of drugs.
Similarly, Jackson gave Danco’s lawyer Jessica Ellsworth some space to explain why pharmaceutical companies have lined up in support of the FDA.
Pharmaceutical companies have “significant concerns” about judges parsing science from the bench, Ellsworth said, because they rely on the “FDA’s gold standard review process”.
“You have a district court that, among other things, relied on one study that was an analysis of anonymous blogposts,” said Ellsworth. Other studies “have since been retracted for lack of scientific rigor and misleading data”.
“Precisely because judges are not experts in statistics and the methodologies used for studies in clinical trials – that is why FDA has many hundreds of pages of analysis in the record of what the scientific data showed, and courts are just not in a position to parse” and “second guess” that, she said.
The most conservative justices want to talk about the Comstock Act
Alito and Clarence Thomas, who make up the most conservative faction of the court, both brought up the Comstock Act, an 1873 anti-obscenity law that bans mailing abortion-related materials.
Although portions of the act are technically still on the books, the Comstock Act has long been regarded as an antique from another era of US history, as past court decisions narrowed its anti-obscenity provisions and Congress rolled back its restrictions on contraception.
But now that Roe no longer provides a constitutional right to abortion, some anti-abortion activists claim the Comstock Act should be enforced and have seeded references to it in anti-abortion litigation, including the lawsuit over mifepristone.
“How do you respond to an argument that mailing your product and advertising it would violate the Comstock Act?” Thomas asked Ellsworth.
“I don’t believe that this case presents an opportunity for the court to opine on the reach of the statute,” Ellsworth replied, after some back and forth.
Thomas may see this case as an invitation to do just that, as he has in the past taken the opportunity to write minority opinions with far-reaching arguments. In the case overturning Roe, Thomas’s opinion suggested the court should re-evaluate landmark cases establishing constitutional rights to same-sex marriage, same-sex intimacy and contraception.
The Biden administration has issued guidance declaring that the Comstock Act only applies if someone intends to break the law. If fully enforced – such as by a future president Donald Trump – the Comstock Act would result in a nationwide de facto ban on abortion, legal experts have said, since abortion clinics, providers and patients rely heavily on the mail for equipment, medicine and other materials that are fundamental to providing care.
