Supreme Court preserves FDA rules for access to abortion pill – but only temporarily

The decision that overturned the FDA’s approval of mifepristone is on hold as the nation’s high court considers the case

The US Supreme Court has temporarily preserved the US Food and Drug Administration’s rules on access to the abortion drug mifepristone as it continues to weigh the issue.

The ruling on 14 April came after a federal appeals court upheld the FDA’s approval of mifepristone but rolled back rules that were put in place in 2016. That came after a ruling last Friday from a federal court in Texas that ruled against the FDA’s approval of mifepristone from 23 years ago, threatening access to abortion care for millions of Americans.

But on Friday, Supreme Court Justice Samuel Alito issued an order that temporarily blocks the Texas decision as the full court weighs the legal challenge. A full order is expected some time next week.

The ruling sets the stage for the Supreme Court’s first big fight on abortion since it issued its ruling in Dobbs v Jackson Women’s Health Organization last year, a decision that revoked a constitutional right to abortion care and overturned Roe v Wade.

Earlier this week, the appeals court partially blocked the ruling from the Trump-appointed judge in Texas that would have stripped mifestiprone’s approval altogether.

But the court did roll back regulations from 2016, which expanded the drug’s approval for use for up to 10 weeks of pregnancy, which is when most people are still learning they are pregnant.

Mifepristone is part of a two-drug protocol for medication abortion, the most common form of abortion care across the US.

“Mifepristone will remain available as it has for the last 23 years, for at least five more days,” said Jenny Ma, senior counsel at the Center for Reproductive Rights.

“This week has created whiplash for healthcare providers and patients – and this order provides cold comfort for a brief few days,” she said in a statement.

Abortion rights advocates have pressed the Supreme Court to take urgent action and reverse the lower courts’ decisions.

Democrats have roundly criticised the ruling from the Northern District of Texas, with almost every member of the Senate Democratic caucus and most House Democrats signing an amicus brief to protect access to mifestiprone. On Friday, the US Department of Justice filed an amicus brief as well.

“If allowed to take effect, the lower courts’ orders would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority,” the amicus brief read. “The resulting disruption would deny women lawful access to a drug FDA deemed a safe and effective alternative to invasive surgical abortion.”

Danco Laboratories, which manufactures the drug, also slammed the appeals court ruling, which the company argues “created regulatory chaos across the country.”

“The direct consequence of the [Fifth Circuit Court of Appeals] ruling is that FDA must effectuate a series of extensive approvals to implement the Fifth Circuit’s rollback,” the amicus brief read. “Without those approvals, Danco cannot legally market and distribute mifepristone.”

Jennifer Dalven, director of the ACLU Reproductive Freedom Project, said the ruling on Friday “is just the first step: Now the courts must put an end to this baseless case – which is part of anti-abortion extremists’ plan to ban abortion nationwide.”

“It threatens access not only to abortion and miscarriage care, but also to a wide swath of critical and life-saving medications,” she added. “No matter what happens next, we know this fight is far from over.”

The Alliance Defending Freedom, the right-wing legal organisation that launched the legal challenge to mifepristone on behalf of a group of anti-abortion activists, said the Supreme Court’s temporary delay “gives the court sufficient time to consider the parties’ arguments before ruling.”