Supreme Court presses pause on mifepristone curbs

The US Supreme Court has said it will allow the abortion pill mifepristone to remain available while an appeal of the decision to strike down its regulatory approval make sits way through the lower courts.

Yesterday, SCOTUS called a halt to a ruling in a Texas district court that overturned the FDA’s approval of the drug more than 20 years ago – at least while the appeal plays out – in a victory for the US government and the pharma industry.

An appeals court ruling shortly after the Texas judgment stopped short of an outright ban on the drug, but rolled back a series of measures the FDA introduced in recent years to make it easier to access it, for example lifting the restriction that it could only be prescribed by doctors, approving its use up to 10 weeks into a pregnancy rather than seven, and legalising distribution by mail.

The pharma industry is also concerned that the ruling could set a dangerous precedent by undermining the FDA when it comes to approval decisions for medicines, creating a situation where judges can effectively ban drugs based on political and personal views and not medical science.

“As we’ve said previously and explained in our amicus brief, Congress gave the FDA the authority to determine whether a medicine is safe and effective for patients to use,” commented Pharmaceutical Research and Manufacturers of America (PhRMA) general counsel Jim Stansel.

“Allowing the courts to second-guess a decision by the FDA to approve a medicine would create significant uncertainty and harm for manufacturers, patients and physicians.”

The Texas court case followed the controversial elimination of the constitutional right to abortion in the US by the conservative-led SCOTUS last June, and was the first time a judge has suspended FDA approval of a medication.

SCOTUS’ decision comes after Justice Samuel Alito extended the deadline for a verdict on the injunction in order to allow more time for the deliberations. And for now, the case returns to the 5th Circuit Court of Appeals, where oral arguments are due to start being heard on 17th May.

The Texas decision came alongside a ruling in Washington state which held that mifepristone is safe and effective and ordered the FDA to retain access to the drug in 17 US states.

US President Joe Biden said in a reaction to the latest SCOTUS ruling: “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.”

Justice Alito and another conservative in the high court – Justice Clarence Thomas – dissented the overall verdict, with the former asserting that the stay requested by the federal government and mifepristone manufacturer Danco Labs could not be granted because the applicants had “not shown that they are likely to suffer irreparable harm” while the Fifth Court of Appeals hears the arguments of the case.

“The Supreme Court’s decision is a huge relief, but we’re not out of the woods yet,” said Nancy Northup, president of the Centre for Reproductive Rights, in a statement.

“For now, providers and patients have the assurance that mifepristone is available and remains an FDA approved drug,” she added. “But we shouldn’t even be here. This case should have been thrown out way before it got to the Supreme Court.”