Attorney General Merrick Garland is hinting he’s ready to get tough on states that block access to an FDA-approved pill used to terminate pregnancies.
He’s got a lot of work ahead of him.
On Friday, the Supreme Court ruled that the U.S. Constitution does not protect the right to an abortion, overruling the landmark 1973 Roe v. Wade decision. In response, the Justice Department declared that it will “work tirelessly to protect and advance reproductive freedom.” Namely, it warned that states can’t restrict access to mifepristone, a drug approved by the FDA in 2000 to terminate pregnancies.
“The FDA has approved the use of the medication mifepristone. States may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy,” Garland wrote in a statement.
Despite Garland’s declaration, more than 30 states have already enacted some form of mifepristone restrictions, according to the Guttmacher Institute, a think tank that supports abortion rights. Some states have had those restrictions on the books for years, and even Democratic administrations have never challenged them.
Legal scholars who spoke with STAT say that states’ mifepristone restrictions are, in fact, vulnerable to a potential legal challenge. That’s because the FDA has the sole authority to approve drugs in the United States. There’s legal precedent, too, for courts striking down states’ restrictions on FDA-approved drugs. Massachusetts’ effort to ban the opioid Zohydro, for example, was struck down because the FDA’s approval of the drug “preempted” the state law.
Patti Zettler, an associate professor of law at Ohio State University, put it simply: “When state and federal law conflict, federal law wins.”
But it won’t be easy to crack down on the mifepristone restrictions — and the process will take some time and creative lawyering.
“It’s true that it is not a slam dunk,” said Greer Donley, an assistant professor of law at the University of Pittsburgh, who authored one of the first papers arguing that mifeprestone laws could be challenged to protect abortion access.
Donley guessed it could take “at least a year, if not two,” for mifepristone restrictions to be overturned — and even longer if the fight gets caught up in appeals.
The potential obstacles are myriad.
First, states have gotten crafty in their restrictions, making them more difficult to challenge.
From a legal perspective, an outright ban on mifepristone would be the easiest to challenge in court, but few states have actually pursued that sort of ban. Instead, they’ve erected restrictions like requirements that people be prescribed the drug in person, which could be especially difficult in states where abortion is banned.
Challenging those sorts of restrictions would likely be more difficult, though proponents of the legal theory insist it can be done.
Zettler, the Ohio State professor, wrote in the New England Journal of Medicine that these restrictions likely could still be challenged by arguing that the state’s restrictions upset the balance the FDA struck when it crafted its safety system, known as a REMS, for the abortion drug.
Even Zettler acknowledged, however, that the argument is not perfect.
“I don’t think that argument is necessarily a complete slam dunk, but I do think there’s a strong argument to be made,” she told STAT.
Second, there’s the question of where to bring a lawsuit. While judges are supposed to be impartial regardless of their political leanings, experts fear that judges in conservative states that most commonly have mifepristone restrictions will be less willing to strike down these rules.
“The problem here is that many of the states that ban abortion are in circuits where the judges are quite hostile to any kind of effort to expand abortion access,” said Donley. “The DOJ here would have to be really thoughtful about what jurisdiction it brought this challenge in.”
And even if a court rules that mifepristone restrictions are “preempted,” it’s unclear how the Supreme Court would rule on that question if the decision was appealed, explained I. Glenn Cohen, the deputy dean of Harvard Law School.
“What they will decide on the issue, I think, is much less certain,” said Cohen. “Preemption makes some strange bedfellows and it’s not something where … there is strong visibility into what Amy Coney Barrett’s views of preemption are.”
And third, the Department of Justice is going to have to contend with an existing lawsuit already challenging one state’s mifepristone restrictions.
One mifepristone manufacturer, GenBioPro, has already brought a lawsuit against Mississippi for its restrictions on the drug.
It’s possible for the DOJ to get involved in that case, but the government will have to contend with a number of challenges it wouldn’t have to deal with if it brought a lawsuit on its own, explained Cohen, the Harvard law vice dean.
First, the government will have to argue the case in whichever court the drug maker chooses.
“The [government] not getting to choose the venue is a bad thing,” he explained. “As the federal government, when you have the choice of venue that is a powerful thing.”
Second, the government will have to navigate the arguments already made by the drug maker.
“One thing about having a private party in the litigation is you can’t control exactly what their litigation position is,” he added.
And third, it also remains to be seen how much of an impact the government can have, given the case is relatively far along. GenBioPro first filed its lawsuit in Oct. 2020.
“I think they much rather would have been involved earlier,” Cohen said.
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