SCOTUS casts doubt on plaintiff’s ability to sue FDA over mifepristone approval

The Supreme Court heard oral arguments in a case that could not only impact access to an abortion pill used by millions of women, but also change the way the Federal Drug Administration approves medicine. However, the justices raised serious questions about challenging the FDA’s approval process and about the plaintiffs standing to sue in the first place. 

The Alliance for Hippocratic Medicine, an organization that says it believes in the sanctity of life from fertilization to natural death, sued over the FDA’s approval of mifepristone, an abortion pill women can take at home to terminate early-stage pregnancies. 

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“Rolling back FDA changes would unnecessarily restrict access to mifepristone with no safety justification,” Solicitor General Elizabeth Prelogar told the justices. “Some women could be forced to undergo more invasive surgical abortions, others might not be able to access the drug at all.”

The FDA approved the drug in 2000. In 2016, the FDA expanded access by only requiring one in-person visit to get a prescription and allowing it to be used through the 10th week of pregnancy. In 2021, during the coronavirus pandemic, the FDA allowed the drug to be prescribed via telemedicine and sent through the mail. 

The original approval and access changes in 2016 and 2021 are at the heart of the case. The justices were presented with multiple questions, including whether a lower court erred when it placed an injunction last year on the 2016 and 2021 FDA actions. 

“In 2021, it eliminated the initial in-person visit based on data it says elsewhere is unreliable. And in 2016, it failed to consider or explain the cumulative effects of its wholesale removal of safeguards,” said Erin Morrow Hawley, an attorney for Alliance Defending Freedom who represented Alliance for Hippocratic Medicine. 

The justices are also deciding whether the plaintiffs have standing to sue in the first place and they cast serious doubt on that, including conservative Justices Clarence Thomas and Neil Gorsuch.  

“Counsel, you assert the, an injury on the part of the Alliance of diverted time and resources,” Justice Thomas asked. “Isn’t it just the cost of litigating, of pursuing this litigation?”

“If you look at how our organizations have been harmed, they’ve been forced to divert resources from speaking and advocating for their pro-life mission generally to explaining the dangers of the harm from abortion drugs,” Hawley responded.

“But that would be anyone who is aggressive or vigilant about bringing lawsuits,” Thomas said. “Just simply by using resources to advocate their position in court, you say now, causes an injury. That seems easily — easy to manufacture.”

Gorsuch raised concern about a universal injunction, something that was echoed by Justice Ketanji Brown Jackson.  

“I went back and looked, and there are exactly zero universal injunctions that were issued during Franklin Delano Roosevelt’s 12 years in office, pretty consequential ones,” Gorsuch said. “And over the last four years or so, the number is something like 60 and — maybe more than that, and they’re a relatively new thing. And you’re asking us to extend and pursue this relatively new remedial course.” 

A decision in the case should be released by June.