The latest ruling over mifepristone’s FDA approval is likely to send the pill’s fate to the US Supreme Court.
A United States appeals court has struck the latest blow in an ongoing battle over the pill mifepristone, often used in medication-induced abortions
On Wednesday, the three-judge Fifth Circuit Court of Appeals in New Orleans overturned a lower court’s wholesale revocation of the pill’s Food and Drug Administration (FDA) approval.
But it kept in place part of the ruling that ends the drug’s availability by mail and limited its use for up to seven weeks of pregnancy, rather than 10. The court’s decision also requires mifepristone to be prescribed by a doctor after an in-person visit.
Those restrictions reverse an FDA decision to loosen guidelines for mifepristone in 2016, in order to increase accessibility for patients.
Wednesday’s decision comes months after a Texas judge in April revoked the drug’s FDA approval, throwing in jeopardy one of the most common methods of abortion in the US.
The latest ruling will likely send the case to the conservative-dominated US Supreme Court, as the administration of President Joe Biden has promised to protect access to mifepristone and defend the authority of the FDA.
Wednesday’s new restrictions are not likely to go into effect immediately though, as the Supreme Court ruled in April that the existing FDA approval would remain in place until the appeals process was exhausted and a final ruling was issued.
Nevertheless, abortion rights groups swiftly condemned Wednesday’s ruling. Many pointed out that mifepristone has enjoyed FDA approval since 2000 and is widely considered safe.
“The fight for #medicationabortion continues — and we’re ready,” NARAL Pro-Choice America, a pro-abortion rights group, tweeted after the ruling.
Latest fight in abortion battle
The fight over mifepristone has emerged as a major front in the ongoing battle over abortion in the US.
The group that brought the original Texas lawsuit, the conservative Christian legal group Alliance Defending Freedom, had also been instrumental in the Mississippi court case which eventually led to the Supreme Court’s decision overturning Roe v Wade.
That June 2022 ruling removed federal protections for abortion and sent questions about the procedure’s legality to state governments. At least 15 states have since moved to impose sweeping bans on abortion access, some with no exceptions for rape or incest, according to a tracker maintained by the New York Times.
In the US, more than half of all abortions use medications like mifepristone, which is used in combination with another drug, misoprostol.
But the plaintiffs in the Texas lawsuit argued that the FDA had acted irresponsibly in approving mifepristone more than two decades ago, calling the pill unsafe.
This effort to strip mifepristone of its FDA approval, however, has alarmed pharmaceutical companies and abortion rights advocates, who consider the lawsuit an ideologically driven scheme unmoored from science.
Lawyers for the US Department of Justice and the pill’s manufacturer had argued that no new information has come out that warrants bringing the medication’s safety into question.
Nevertheless, Judge Jennifer Walker Elrod wrote in Wednesday’s decision that the FDA failed “to address several important concerns about whether the drug would be safe for the women who use it”.
She denounced the loosening of FDA guidelines in 2016, accusing the agency of removing “safeguards” for mifepristone. Elrod was joined in her decision by Judge Cory Wilson, a fellow Trump appointee.
The third member of the court, Judge James Ho, dissented. He has previously indicated he was in favour of stripping mifepristone of its original 2000 FDA approval.
In a statement on Wednesday, US Senator Ron Wyden decried the ruling as a “political ploy to control women’s bodies”.
“The fate of women’s access to this lifesaving drug is now back in the hands of the Supreme Court — a terrifying thought for those of us who don’t trust the right-wing justices who overturned Roe and who claimed abortion is an issue to be left to the states,” he wrote.
