A fight over abortion pills at the Supreme Court this week could have sweeping consequences for all Americans’ access to mifepristone, even those who live in blue states.
Abortion will be back in court Tuesday, when the same justices who overturned Roe v. Wade will hear arguments about whether federal regulators overstepped their authority by loosening restrictions to make mifepristone easier to access.
Mifepristone, which is sold both under the brand name Mifeprex and as a generic drug, is commonly used with one other drug during medication abortions. The stakes of the case were made clear this week when new data showed more than 60 percent of all abortions last year were done through medication.
“They’re really seeking to go back to a state of regulation of the drug that is not in keeping with evidence-based practices and that is not in keeping with FDA’s judgment today; that could have nationwide implications,” said Skye Perryman, president and CEO of Democracy Forward.
The Food and Drug Administration (FDA) made a series of changes in 2016, 2021 and 2023 that included increasing the gestational age at which mifepristone can be used to up to 10 weeks of pregnancy, allowing the medication to be mailed to patients, lowering the dosage, allowing telehealth prescribing, and permitting providers other than physicians to prescribe the drug.
A group of anti-abortion doctors and medical associations represented by the Christian legal group Alliance Defending Freedom would like the justices to uphold an earlier ruling from the U.S. Court of Appeals for the 5th Circuit.
There is no legal precedent for a court to override the Food and Drug Administration’s approval of a drug. But if it were to happen, experts said it could upend the entire drug approval process and make abortion medication out of reach of the people who need it most.
“That would be a sea change in how courts review health care and drug access in the United States,” said Aadika Singh, senior reproductive justice attorney at Public Rights Project.
If the Supreme Court upholds the 5th Circuit’s ruling, 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 would take time. The manufacturer and distributors won’t be able to market the drug until it gets relabeled.
While mifepristone will likely stay on the market no matter what the Supreme Court decides, there could be some significant changes to access, even in states where abortion remains legal and protected.
If the justices uphold the ruling from the appeals court, prescribing mifepristone through telemedicine would no longer be allowed. Since the end of Roe, the number of people seeking to terminate pregnancies who rely on telemedicine has increased.
Abortion is almost completely illegal in 14 states, while two states have banned it after six weeks.
Telemedicine abortion accounted for 16 percent of abortions performed from June to September 2023, according to the latest data published by the Society of Family Planning.
“Given that there’s a greater need for mifepristone, and given that now there are fewer places, fewer states where mifepristone can be lawfully prescribed, telemedicine was the way for communities to meet the challenge, not only for their own residents but for people coming in from out of state seeking care,” Singh said.
Mifepristone represents the latest front in the abortion fight, and the Supreme Court’s decision — expected in June, in the middle of a presidential campaign — isn’t expected to be the final say.
If the court rules against the FDA, it could open the door to politically motivated challenges against other drugs or medical devices.
“That could really unleash a lot of judicial mischief with respect to extremist organizations that are seeking to misuse our court system and our laws,” said Perryman.
Pharmaceutical industry experts and reproductive rights groups said they are especially concerned about vaccines and contraception.
“All the myths and ‘alternative facts’ that we hear … the scientific evidence is now vulnerable to those kinds of misleading statements,” Marsha Henderson, a former associate commissioner for women’s health at the FDA, said during a recent media briefing. “And so it would not surprise me that the courts would be flooded with various suits that would come if this one is successful.”
Even if the Supreme Court decides in favor of the Biden administration, or rules that the anti-abortion groups don’t have legal standing to sue, attorneys said litigation would likely continue.
For instance, the same district court in Texas that originally ruled against the FDA said a group of red states led by Missouri can intervene in the lawsuit.
Adam Unikowsky, a partner at Jenner & Block, said if the Supreme Court rules the plaintiffs have no standing, the case should just go away. Individual states can later sue to challenge the FDA’s decisionmaking if they want to, but they shouldn’t be able to sue in courts outside their own borders.
“A ruling that there’s no standing would not end the litigation forever,” Unikowsky said. “Someone else could certainly give it a shot.”
However, he noted that the Texas district court could decide to let the states sue anyway.
“So there is a possibility in which the Supreme Court holds that there’s no standing, and then the District Court allows the states to proceed with their case, and then we come right back up [to the Supreme Court] in a couple of years,” Unikowsky said.
Thomas Jipping, a senior legal fellow at the Heritage Foundation, said during a recent briefing that several anti-abortion states have contemplated filing lawsuits challenging the FDA’s decisionmaking.
Jipping said even if the FDA loses, it won’t be the apocalyptic scenario the agency laid out in court documents.
“The FDA can go back to the drawing board, and there can be new drug applications, the whole process can work its way through again. This isn’t going to affect the way they do anything; the entire pharmaceutical industry is well familiar with all those legal standards and the changing landscape, and they have to act accordingly,” Jipping said.
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