Supreme Court Justices Clash Over Abortion Drugs

Supreme Court justices have clashed over whether judges are qualified to overturn Food and Drug Administration (FDA) approvals of medications such as abortion drug mifepristone.

Justice Ketanji Brown Jackson questioned the "scientific knowledge" of judges such as fellow Supreme Court Associate Justice Samuel Alito, in comparison to the expertise and procedures of the FDA, during oral arguments on Tuesday.

The court was hearing the Biden administration's appeal of a lower court's ruling to limit how mifepristone, used in more than 60 percent of U.S. abortions, is prescribed and distributed. It is the court's first major abortion case since conservative justices overturned Roe v. Wade two years ago, when several states banned or severely restricted access to procedures.

The clash came when Alito, a member of the court's conservative wing who authored the 2022 ruling overturning Roe, asked if the FDA is "infallible." Jackson responded by asking if there were concerns about judges "parsing medical and scientific studies."

The abortion opponents who challenged the FDA's approval of mifepristone and subsequent actions to ease access to it might not have the required legal standing to sue in the first place, the court heard. Arguing for the Biden administration, Solicitor General Elizabeth Prelogar said the plaintiffs had failed to show that they have been harmed in a way that can be traced to the FDA and urged the court to dismiss the case.

The FDA has told Newsweek via email: "The FDA does not comment on possible, pending or ongoing litigation."

Such a decision would leave in place current rules allowing patients to receive the drug through the mail without first seeing a clinician in person, and to take the medication to induce an abortion through the first 10 weeks of pregnancy.

The Biden administration and Danco Laboratories, which makes mifepristone, say the drug is among the safest ever approved by the FDA. They warn that a ruling in favor of abortion opponents could undermine the FDA's drug approval process if it means judges second-guess the agency's scientific judgments.

A White House spokesperson told Newsweek on Wednesday: "We are confident in our arguments before the Court. We will continue to stand by and defend FDA's approval and regulation of this medication, and President Biden and Vice President Harris remain firmly committed to defending a women's ability to access reproductive care."

"During the questioning of the Solicitor General, the statement was made that no court has ever previously second-guessed the FDA's judgment about access to a drug, right?" Alito said. "Do you think the FDA is infallible?"

Jessica Ellsworth, an attorney representing Danco, replied: "No, your honor, we don't think that at all. And we don't think that question is really teed up in any way in this case."

Jackson, a Biden appointee who joined the court in 2022 after Roe was overturned, later asked Ellsworth: "So you were asked if the agency is infallible, and I guess I'm wondering about the flip side, which is do you think that courts have specialized scientific knowledge with respect to pharmaceuticals, and as a company that has pharmaceuticals, do you have concerns about judges parsing medical and scientific studies?"

Ellsworth replied: "Yes, your honor, I think we have significant concerns about that. And there are two amicus briefs from the pharmaceutical industry that expand on why exactly that's so concerning for pharmaceutical companies who do depend on FDA's gold standard review process to approve their drugs and then to be able to sell their products in line with that considered judgment."

She added that the lower court's ruling "is a good example of that."

"You have a district court that among other things relied on one study that was an analysis of anonymous blog posts," she added.

"You have another set of studies that he relied on that were not in the administrative record and would never be because they post-date the FDA decisions here. They have since been retracted for lack of scientific rigor and for misleading presentations of data.

"Those sorts of errors can infect judicial analyses precisely because judges are not—they are not experts in statistics. They are not experts in the methodology used for scientific studies, for 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 through and second-guess that."

In a statement provided to Newsweek, Ellsworth added: "Second-guessing the scientific and data-driven judgments of an independent expert agency is an extreme position that could inject further uncertainty across American life.

"Under the respondent's theory, the medicines Americans rely on to manage and cure any number of conditions and diseases could be in jeopardy years after FDA approval. And the ability of the American pharmaceutical industry to develop and get approval for new drugs would be severely harmed, slamming the door on promising research into medicines for everything from Alzheimer's to cancer. Fortunately, there is no basis, either in law or precedent, to find for the respondents, and we have urged the Court today to overturn the Fifth Circuit's decision."

In August 2023, the U.S. Court of Appeals for the 5th Circuit ruled that the FDA's decision to allow mifepristone to be taken later in pregnancy, be mailed directly to patients and be prescribed by a medical professional other than a doctor were not lawful.

Federal Appeals Judge Jennifer Walker Elrod wrote in the opinion: "In loosening mifepristone's safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it. It failed to consider the cumulative effect of removing several important safeguards at the same time."

Update 3/27/24, 10:30 a.m.: This article has been updated to include comment from the White House and Jessica Ellsworth.