The Supreme Court is re-entering the debate on abortion, as it agreed this week to hear an appeal from the Biden administration about access to the abortion pill mifepristone.
While an argument date isn’t set, a decision will likely come in June, almost exactly two years after the same justices overturned Roe v. Wade.
Whatever the court decides could have sweeping ramifications. While the pills will likely stay on the market, there could be some significant changes to access, even in states where abortion remains legal and protected.
Mifepristone is part of a two-drug treatment regimen widely used across the U.S. to end a pregnancy in the first 10 weeks of gestation. Approved in 2000, about half of all abortions nationwide are performed using mifepristone, according to the Guttmacher Institute, a reproductive rights research and advocacy group.
How we got here
The court granted a request from the Justice Department and one from Danco, the manufacturer of Mifeprex, after the U.S. Court of Appeals for the 5th Circuit ruled in August that mifepristone can stay on the market in states where abortion is legal, but changes the FDA made since 2016 to ease access to the drug were not allowed.
Those included increasing the gestational age when mifepristone can be used up to 10 weeks of pregnancy rather than seven, allowing the medication to be mailed to patients, lowering the dosage, allowing telehealth prescribing, and permitting providers other than physicians to prescribe the drug.
The justices declined to review a request from the anti-abortion plaintiffs in the case to reinstate a lower court’s sweeping ban on mifepristone.
By deciding to take up the case, the Supreme Court is now in a position to weigh in on abortion even after its conservative majority said that question would be left to elected officials.
The decision could have major implications for the biopharma industry and the Food and Drug Administration’s (FDA) approval authority.
The antiabortion group behind the challenge asserted that the FDA did not sufficiently consider safety concerns when it approved the drug in 2000 or when it removed restrictions in more recent years.
What could happen next
Option 1: SCOTUS upholds the entirety of the Fifth Circuit decision
This would be a victory for the Alliance Defending Freedom, the far-right group representing the anti-abortion providers in the case, especially since the justices did not take up its challenge to mifepristone’s original approval.
If the justices uphold the Fifth Circuit’s ruling, it would essentially turn back the clock to 2015 and make mifepristone more difficult to obtain.
“If the Supreme Court issued a decision in line with the Fifth Circuit’s it would still have very disruptive, very harmful effects for abortion access across the country” even though it’s not as extreme as revoking mifepristone’s approval entirely, said Greer Donley, a law professor at the University of Pittsburgh.
Donley said it would also be a significant blow to FDA’s authority.
“It’s hard enough to get a drug approved by the FDA … so to have the court second-guessing that FDA decision and allowing any health care provider to have standing to challenge them really opens the door to broad, wide-ranging lawsuits for any drug where there’s a politically motivated reason to try to have it regulated more strongly,” Donley said.
Manufacturers would have to change the drug’s label and the FDA would need to rewrite its rules and regulations for distribution and use of the drug, which will take time. The manufacturer and distributors won’t be able to market the drug until it gets relabeled.
The higher dosage of mifepristone also comes with greater risk of side effects.
“The [FDA] has maintained that scientific judgment across five presidential administrations, while updating the drug’s approved conditions of use based on additional evidence and experience,” the Department of Justice wrote in a court filing.
Option 2: SCOTUS reverses the Fifth Circuit’s decision
This is what the White House and Danco Laboratories, the pharmaceutical industry and abortion-rights advocates are asking the high court to do.
Reversing the Fifth Circuit’s ruling would ensure the status quo remains in place, and mifepristone would stay on the market without any changes. States that currently restrict prescribing and mailing mifepristone would still be allowed to do so.
It would be a significant blow to the anti-abortion groups, though legal experts have said the arguments used to justify their challenge were shaky at best.
In a filing asking the Supreme Court to take the case, Solicitor General Elizabeth Prelogar wrote that if the appeals court’s decision is allowed to take effect, “it would upend the regulatory regime for mifepristone, with damaging consequences for women seeking lawful abortions and a healthcare system that relies on the availability of the drug under the current conditions of use.”
Danco’s attorney Jessica Ellsworth argued Mifeprex is safe and effective, and that the appeals court’s decision “upends FDA-approved conditions of use” for the drug.
The decision “raises questions about whether a single federal court can limit abortion access in the States that protect it. And it destabilizes the pharmaceutical and biotechnology industries by questioning when scientific studies — accepted by FDA — are sufficient to support conditions of use,” Ellsworth wrote.
Option 3: Something different
It’s possible the justices could uphold some post-2016 changes but invalidate others.
Legal experts were hesitant to predict what the justices could do, and just because an option makes sense doesn’t mean it’s likely.
If access to mifepristone were restricted, abortion providers and advocates said pregnancies could still be terminated using misoprostol, the second drug in the regimen.
But misoprostol alone causes more cramping and bleeding and is not as effective as using both drugs. If they are successful at imposing limits on mifepristone, abortion opponents could also move to restrict misoprostol use as well.
