The abortion pill mifepristone will remain available in the US for now—but its long-term fate is uncertain as a bitter legal battle unfolds.
A federal appeals court ruled yesterday in favor of keeping the drug on the market but rolled back changes the US Food and Drug Administration has made in recent years to expand access to it. Notably, the ruling states that the drug must be dispensed in person and limits the timeframe in which it can be taken to the first seven weeks of pregnancy.
The order, issued by the US Fifth Circuit Court of Appeals, partly overruled last week’s decision by Judge Matthew Kacsmaryk of the Northern District of Texas invalidating the FDA’s approval of the pill in 2000. The FDA is the federal agency tasked with assessing the safety and efficacy of drugs.
Mifepristone blocks a hormone called progesterone that’s essential for a pregnancy to continue. It’s used alongside another drug, misoprostol, in a two-pill regimen to bring about a medical abortion. The appeals court said too much time had passed since the drug’s approval to bring a lawsuit against the FDA for authorizing mifepristone. But the three-judge panel upheld a separate part of Kacsmaryk's decision, which undoes FDA decisions in recent years that made mifepristone easier to prescribe and obtain.
In 2016, the FDA loosened some of its earlier provisions, allowing patients to take the drug up until 10 weeks of pregnancy rather than seven, reducing requirements for an in-person visit with a doctor from three to one, and allowing clinicians other than physicians to prescribe and administer it. Then in 2021, during the pandemic, the FDA announced that it would use its “enforcement discretion” to temporarily allow mifepristone to be dispensed through the mail or a mail-order pharmacy. In January, the FDA lifted the in-person dispensing requirement entirely. But the circuit court decision winds the clock back to the rules that existed in the year 2000.
“Even though this softens the blow of Judge Kacsmaryk’s ruling, it is just as problematic and concerning,” says David Cohen, a professor of law at Drexel University, referring to the restrictions that the appeals court placed on the pill. He says it’s still an attempt by the courts to influence how an already approved drug can and cannot be used. “It’s a lawless opinion without respect to the deference of the FDA.”
Since it became clear in 2022 that the US Supreme Court would overturn Roe v. Wade, experts have predicted that conflicts would arise between states and the federal agency over which drugs are allowed in which states, and if they can be shipped there by mail—thus undermining the longstanding agreement that federal regulations should supersede the wishes of individual states.
“We had accepted that federal law would preempt state law, that it would be preposterous that one federal judge in one district in Texas—or in any other state—would be able to affect the availability of a drug that had had FDA approval for 20 years,” says Khiara M. Bridges, a professor of law at the University of California, Berkeley. “Now the things that we thought we knew about the relationship between federal law and state law, and the FDA’s ability to regulate, have been called into question.”
Doctors, scientists, and legal scholars say the rulings create a risk that judges could reverse FDA approvals for other drugs that may be politically controversial, such as hormonal birth control, drugs that prevent HIV infection, or even Covid-19 vaccines. “There's an easy path to get them invalidated right now,” says Cohen, who was a coauthor of a widely read law review article on the federal-state conflict.
Scholars now worry that the arguments made in the Kacsmaryk opinion could be applied to any pharmaceutical for which someone might imagine a moral objection—for instance, vaccines grown in fetal fibroblast cell lines dating back to the early 1960s. (That includes commonly used vaccines against rubella, chickenpox, and hepatitis A.) But based on the opinion’s criticisms of the path by which mifepristone came to market, it’s also possible it could be used to support objections against drugs that came to market via accelerated pathways or other alterations to the by-the-book approval process—or to litigate claims of drug harm.
“How many folks claim to have been injured by vaccines or have been injured by [being] allergic to penicillin?” Bridges asks. “How many people can say they have been injured by drugs and could use those numbers as a reason to doubt the legitimacy of the approval process? We're in really shaky territory when it comes to certainty about things that are available today.”
Other experts worry that the ruling could have a chilling effect on the development of new drugs as well as the availability of existing ones. “This case is not just about one drug; the arguments the plaintiffs are making are about FDA law,” says Patricia Zettler, an associate professor of law at The Ohio State University Moritz College of Law. “So the outcome will have implications for pharmaceutical innovation and for patient access to all kinds of drugs.”
Zettler, who coauthored a 2022 editorial in The New England Journal of Medicine arguing that federal drug approvals must take precedence over state preferences—something not expressly specified in the FDA’s statutes—says the ruling could invalidate the assumptions that underpin almost all federal drug regulation. “It's a really scary prospect that patients may not be able to rely on having access to what FDA thinks should be an approved drug,” she says.
Equally, she adds, pharmaceutical investment would become pointless. “Industry has to spend a lot of time and a lot of resources to do the hard work to identify promising drugs, and figure out if they're safe and effective for a given use,” she says. “That takes a lot of time and a lot of money. And the incentives to do that hard work to come up with innovative new products are seismically undermined if there's no certainty about the ability to market a product once it's proven safe and effective.”
Earlier this week, executives from biotech and pharmaceutical companies issued a scorching letter condemning Kacsmaryk’s decision as an act of “judicial activism” that puts “an entire industry focused on medical innovation at risk.” The letter has garnered more than 600 signatures and counting. The Biotechnology Innovation Organization, the world's largest biotech trade association, was one of the organizations that signed on to an amicus brief asking the Fifth Circuit to suspend the ruling until an appeal can be heard.
In a statement, Jim Stansel, executive vice president of the Pharmaceutical Research and Manufacturers of America, or PhRMA, called the FDA the “gold standard for determining whether a medicine is safe and effective” and said the group has “serious concerns with any court substituting its opinion for the FDA’s expert approval decision-making.”
Marcus Schabacker, president and CEO of ECRI, a global independent nonprofit organization that advances evidence-based medicine, worries about the effect the rulings could have on patient safety. With medication abortion in legal limbo, it creates ambiguity about what health care providers can and cannot do. “When the court steps in and creates that kind of uncertainty, it endangers patients. That's what we worried about,” he says. “This introduces additional risk.”
Even if mifepristone ultimately becomes unavailable in the US, medication abortion is still possible with just misoprostol, the other half of the two-pill regimen. This drug is typically taken 24 to 48 hours after mifepristone to dilate the cervix and cause contractions, which empties the womb. Though less effective than taking both pills, a misoprostol-only regimen is endorsed by the World Health Organization and the American College of Obstetricians and Gynecologists as an acceptable alternative.
The latest ruling isn’t the final word, however. The FDA could choose to exercise its enforcement discretion, meaning it would not enforce the restrictions set by the Kacsmaryk ruling. If that happens, it would allow providers to continue to prescribe the pill up to 10 weeks into pregnancy and dispense the pill through the mail.
“Enforcement discretion is a normal part of the American justice system,” Cohen says. “Just think of all the times you've driven over 55 miles an hour on the highway and police officers haven't pulled you over because they're using their enforcement discretion.”
There’s no clarity on what happens next. One week ago—on the same day that the Kacsmaryk opinion landed—a federal judge in Washington state ruled that the FDA must keep mifepristone available in that state, 16 others, and the District of Columbia. Washington state lies in the Ninth Circuit, and that puts rulings from two separate circuits of the court system into direct conflict. That kind of conflict usually must be decided by the Supreme Court, and scholars now assume the battle over mifepristone access is headed there.
This morning, US Attorney General Merrick Garland said the US Justice Department would seek emergency relief from the Supreme Court to block the restrictions on mifepristone created by the Kacsmaryk opinion, possibly bringing the issue before the court immediately. With things moving so fast, experts said, it is impossible to predict what the next ruling might be.
WIRED will continue to update this story as it develops.
