In April 2023, the Trump-appointed judge Matthew Kacsmaryk of the Northern District of Texas issued a preliminary ruling on the FDA case invalidating the agency’s approval of mifepristone. The ruling sent shock waves far beyond the reproductive-rights world, as it had major implications for the entire pharmaceutical industry, as well as the FDA itself; the ruling suggested that the courts could revoke a drug’s approval even after decades on the market.
The US 5th Circuit Court of Appeals narrowed Kacsmaryk’s decision a week later, allowing the drug to remain on the market, but undid FDA decisions in recent years that made mifepristone easier to prescribe and obtain. That decision limited the time frame in which it can be taken to the first seven weeks of pregnancy and put telemedicine access, as well as access to the generic version of the drug in jeopardy.
Following the 5th Circuit ruling, the FDA and Danco Laboratories sought emergency relief from the Supreme Court, asking the justices to preserve access until it could hear the case. In its legal filing, Danco aptly described the situation as “regulatory chaos.”
Scotus issued a temporary stay, maintaining the status quo; the court ultimately decided to take up the case in December 2023.
As all this was unfolding, pro-abortion-rights states across the country were passing what are known as shield laws, which protect medical practitioners who offer abortion care to pregnant patients in states where abortion is banned. This has allowed some providers, including the longtime medication-abortion-advocacy group Aid Access, to mail abortion pills to people who requested them in states like Louisiana and Arkansas.
Though the oral arguments before the Supreme Court begin on Tuesday, it will likely be months before a ruling. Court watchers suspect a decision may be handed down in June. With the US presidential election in the fall, the ruling may become a major campaign issue, especially as abortion access helped galvanize voters in the 2022 midterms.
If the Supreme Court agrees with the plaintiffs that mifepristone should be taken off the market, some in the pharmaceutical industry worry that it will undermine the authority of the FDA, the agency tasked with reviewing and approving drugs based on their safety and efficacy.
“This case isn’t about mifepristone,” says Elizabeth Jeffords, CEO of Iolyx Therapeutics, a company developing drugs for immune and eye diseases. Jeffords is a signatory on an amicus brief filed in April 2023 that brought together 350 pharmaceutical companies, executives, and investors to challenge the Texas district court’s ruling.
“This case could have easily been about minoxidil for hair loss. It could have been about Mylotarg for cancer. It could have been about measles vaccines,” Jeffords says. “This is about whether or not the FDA is allowed to be the scientific arbiter of what is good and safe for patients.”
Greer Donley, an associate professor of law at the University of Pittsburgh and an expert on abortion on the law, doesn’t think it’s likely that the court will revoke mifepristone’s approval entirely. Instead, she sees two possible outcomes. The Supreme Court could dismiss the case or could undo the FDA’s decision in 2023 to permanently remove the in-person dispensing requirement and allow abortion by telehealth. “This would be an even more narrow decision than what the 5th Circuit did, but it would still be pretty devastating to abortion access,” she says.
