The US Supreme Court will allow a drug used in more than half of the country’s abortions to remain available while a legal fight over its decades-long regulatory approval plays out in lower courts.
The court on Friday halted a ruling by Texas federal judge Matthew Kacsmaryk, who earlier this month suspended the authorisation of mifepristone while the appeals process runs its course.
The move is a win for the US government and pharmaceutical sector in their legal fight over the abortion drug. Both the Department of Justice and Danco Laboratories, which makes mifepristone, challenged the Texas ruling, which suspended regulatory approval for mifepristone granted more than 20 years ago, in effect leading to a nationwide ban.
A federal appeals court later paused most of the Texas ruling. It did allow portions — which effectively reinstated limits on the distribution of mifepristone that the Food and Drug Administration had gradually loosened since 2016 — to take effect while the appeal proceeded.
Justice Samuel Alito had twice extended the court’s deadline to act on the appeal to the high court. On Friday, the majority of the court agreed to suspend the Texas ruling for now. But Alito and fellow conservative justice Clarence Thomas said they would have denied the application to do so.
Alito wrote in dissent that petitioners “have not shown that they are likely to suffer irreparable harm” while the case proceeds.
It is the latest step in a legal fight that has caused upheaval in abortion care across the country after the Supreme Court last year overturned Roe vs Wade, which had enshrined the constitutional right to the procedure for nearly five decades.
US president Joe Biden said in a statement after the decision: “I continue to stand by FDA’s evidence-based approval of mifepristone, and my administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs.
“The stakes could not be higher for women across America.”
The Texas ruling has rattled abortion advocates and providers as well as mifepristone producers. The US government had said it “raises a host of unprecedented issues”. It has also raised concerns about whether courts can second-guess regulatory decisions more broadly that have been in place for years.
Carrie Flaxman, senior director of public policy litigation at Planned Parenthood, a non-profit group providing abortion care, said the withdrawal of pills containing mifepristone would have a “devastating impact” on abortion care. Healthcare groups face a “chaotic and confusing” situation because they do not know what type of care they can offer patients on a day-to-day basis, she added.
“The biggest impact is on patients, who are trying to navigate access to care,” Flaxman said. “There is a lot of confusion about the status of abortion and medication abortion.”
A potential option for healthcare providers is to offer patients a different drug, misoprostol, she added. While typically administered in combination with mifepristone in medication abortions, misoprostol is safe and effective when used on its own and has been offered in other countries, Flaxman said.
“But to be clear, it is not a simple thing for the healthcare community which has relied on one medication, one regimen, for over 23 years just to turn on a dime and be able to provide care,” she added.
The pharmaceutical industry has said the restrictions proposed by the Texas ruling ignore decades of scientific evidence and legal precedent and, if implemented, would cause regulatory chaos and put the industry at risk.
Danco, one of the main manufacturers of abortion pills containing mifepristone, said the restrictions would possibly force it to stop selling the drug and halt operations. GenBioPro, the maker of a generic version of abortion pills containing mifepristone, this week filed a lawsuit seeking to allow it to continue to sell its pill amid the continuing legal battles.
Amanda Banks, an adviser at Harbinger Health, was one of more than 700 pharmaceutical executives who signed an open letter condemning the Texas ruling, said the industry would continue to advocate for the FDA’s authority to regulate new medicines and patients’ ability to access these medications.