Mifepristone ruling – latest: Supreme Court decision keeps medical abortion pill approval in place

The Supreme Court’s decision on Friday, hours before its self-imposed midnight deadline, means that the FDA’s 23-year-old approval of mifepristone will remain in place while a high-profile challenge mounted by an anti-abortion activist group continues in a lower court.

Everything we know so far:

New York Attorney General Letitia James led a coalition of 24 attorneys general urging the Supreme Court to block the federal court decision that would strike down mifepristone’s government approval.

Following the Supreme Court’s decision to keep the approval in place while the legal challenge continues, she said the ruling is a “major relief for millions of Americans.”

New York Governor Kathy Hochul was among several Democratic state leaders across the US stockpiling thousands of doses of abortion drugs in the event that they were no longer on the market without FDA approval.

“As the appeals process moves forward, I will use the full force of my office to help ensure that medication abortion options, including mifepristone, remain available and protected in New York. It’s your body, and it should always be your choice,” Ms James added.

The two dissenting justices in the Supreme Court’s decision are Clarence Thoms and Samuel Alito, who wrote the opinion that struck down Roe v Wade.

It’s typical in such emergency motion decisions that the justices do not explain their vote or reveal them. Justice Alito, however, argued that the public would not have been harmed by keeping intact a ruling that strikes down recent FDA changes that expanded access to mifepristone.

“It would simply restore the circumstances that existed (and that the Government defended) from 2000 to 2016 under three Presidential administrations,” he wrote. Those rule changes expanded access to the drug for patients up to the 10th week of pregnancy and allowed prescriptions by mail and telehealth appointments, rather than repeat visits to abortion providers – in many states, they are hundreds of miles away or nonexistent.

He rejected the idea that “chaos” would follow as a result of two different federal court rulings from earlier this month – one from Texas that struck down the FDA’s approval and another in Washington state that preserved the status quo.

“That should not be given any weight,” he added.

Vice President Kamala Harris, who has led efforts at the White House on reproductive healthcare in aftermath of Roe, said in a statement that the administration will “continue to fight to protect a woman’s freedom to make decisions about her own body and access to reproductive health care, including medication abortion.”

“No one should stand between a woman and her doctor,” she added.

Our Administration will not waver in our commitment to preserving access to essential medication and defending the FDA’s ability to approve safe and effective drugs,” she said. “Americans need to look no further than their medicine cabinet to see how many FDA-approved medications are at risk if lower court decisions disregarding the FDA’s scientific judgment are allowed to stand.”

It was unclear whether the justices on the conservative supermajority court would uphold the Texas ruling or pause the decision while the legal battle continues, but the Supreme Court has now blocked a federal court ruling against mifepristone from taking effect while the case returns to the appeals court.

The case of Alliance for Hippocratic Medicine v FDA returns to the Fifth Circuit Court of Appeals in Louisiana.

Both parties will have a chance to file briefs, and the case will be argued before a three-judge panel on 17 May.

In the meantime, mifepristone remains legal and accessible and its FDA approval is intact.

In his dissent in the Supreme Court’s decision to pause a federal court ruling that would strip the FDA’s approval of a widely used abortion drug, conservative Justice Samuel Alito took direct aim at the Biden administration with an extraordinary accusation that the president would disobey the court.

He suggested that the White House would ignore a ruling that would not be in its favour, but no administration officials has suggested that. Several members of Congress have argued that the administration should ignore a ruling that undermines the FDA’s authority, but the administration has said that the case must play out in the courts to affirm the government’s regulatory authority.

Mr Alito, who authored the ruling that struck down Roe v Wade last year, suggested that the administration would consider disobeying "an unfavorable order".

Democratic congresswoman Alexandria Ocasio-Cortez, among lawmakers who said the administration should ignore an order that strips the FDA’s authority, said the court “has devolved into a highly politicized entity that is rapidly delegitimizing.”

A decision on the Supreme Court’s so-called “shadow docket” doesn’t provide much detail about the court’s decision making behind the action.

That is also the case in the closely watched mifepristone case, which has profound effects on abortion access.

In the mifepristone case, the order simply pauses a lower court ruling while the case continues, potentially signalling that the nation’s high court isn’t likely to agree with them in the future, while the appeals process picks up next month.

But there were two dissenting justices – Clarence Thomas and Samuel Alito, who used his dissent to criticise his colleagues on the bench, including fellow conservative Amy Coney Barrett, for their previous warnings about abusing the shadow docket.

“I did not agree with these criticisms at the time, but if they were warranted in the cases in which they were made, they are emphatically true here,” he said.

He also said the Supreme Court didn’t need to step into the case because an appeals court already “narrowed” the Texas decision. The appeals court kept the FDA approval in place but rolled back significant changes that would upend abortion access.

Justice Alito also criticised another federal judge in Washington state who issued a competing decision in an unrelated case that argued the FDA to preserve the status quo when it comes to mifepristone.

Finally, he took aim at the Biden administration, saying that “the Government has not dispelled legitimate doubts that it would even obey an unfavorable order in these cases, much less that it would choose to take enforcement actions to which it has strong objections.”

The US Supreme Court has preserved access to a widely used abortion drug while legal challenges against mifepristone’s government approval continue, marking the court’s first major decision on abortion rights in the year after a constitutional right to abortion care was revoked.

The decision from the nation’s high court on 21 April will maintain the US Food and Drug Administration’s approval of the drug, which is used in more than half of all abortions in the US, after a federal judge in Texas struck it down in a ruling that would have profound and potentially dangerous consequences for millions of Americans if allowed to go into effect.

The case now returns to the Fifth Circuit Court of Appeals in Louisiana, where both parties will have a chance to file briefs. The case will be argued before a three-judge panel on 17 May.

The end of Roe v Wade triggered a wave of state-level anti-abortion laws and restrictions. More than a dozen states, mostly in the US South, have effectively banned abortion for most pregnancies with limited if any exceptions. Florida is the most recent state to implment a ban on abortion care at six weeks of pregnancy, when people are still learning if they are pregnant.

The new law means that abortion care is effectively outlaws across the entire South.

Abortion providers and civil rights groups have warned of grave consequences to the loss of widely used abortion drugs from the market.

Providers could turn to a misoprostol-only medication abortion regimen, though that would be considered an “off-label” pharmaceutical use for the drug in the US. Misoprostol is currently approved by the FDA for the prevention and treatment of gastric ulcers but also is administered for other obstetric or gynecologic care.

Several Democratic-led states are stocking up on mifepristone and proposing legal protections for pharmacists and providers who dispense the drug.

A ruling that undermines the FDA’s drug approval process could also open the door for other activist-driven legal battles over other drugs, potentially inviting other destabilising lawsuits to Covid-19 vaccines, contraception, HIV medication, gender-affirming care, and other life-saving drugs.

The Supreme Court’s ruling on 21 April ensures that the drug remains available, for now, while the legal battle continues in a federal appeals court.