SCOTUS blocks restrictions on abortion pill mifepristone

In the latest twist and turn of the rancorous abortion pill battle in the US, the Supreme Court has temporarily halted a lower court ruling that would have restricted access to mifepristone.

Justice Samuel Alito implemented a temporary stay on the decision – albeit only until 19th April – which will give SCOTUS more time to consider an appeal against the Texas ruling filed by the White House and supported by the FDA and dozens of companies in the biopharma industry.

The intervention by Alito effectively freezes the Texas ruling by Judge Matthew Kacsmaryk, which overturned the FDA’s two decades-old approval of mifepristone and, according to the regulator, places its authority as the arbiter of drug safety and efficacy in jeopardy.

That outcome was taken to an appeals court, which ruled last week that mifepristone could remain available. However, it rolled back a series of measures aimed at improving access to the drug – including allowing it to be sent to patients by mail and removing a restriction that it be prescribed by a doctor – that had been introduced by the FDA in the last couple of years.

Some of those measures were introduced in the aftermath of the controversial elimination of the constitutional right to abortion in the US last June. Mifepristone is used in around half of all abortion procedures in the US.

In its filing with SCOTUS, the Department of Justice said that allowing the revocation of mifepristone’s FDA approval introduces “regulatory chaos” and has “sweeping consequences for the pharmaceutical industry, women who need access to the drug, and the FDA’s ability to implement its statutory authority.”

White House Press Secretary Karine Jean-Pierre said in a statement, meanwhile, that President Joe Biden and his administration “continue to stand by FDA’s evidence-based approval of mifepristone,” and added: “The stakes of this fight could not be higher in the face of ongoing attacks on women’s health.”

Mifepristone manufacturer Danco Laboratories indicated in a filing to SCOTUS that it has been thrust into limbo by the lower court rulings, saying that it will only be able to keep mifepristone on the market if the FDA carries out a series of “extensive approvals” – and the regulator is currently barred from doing so under order from a court in Washington.

That court ruling found that mifepristone is safe and effective and ordered the FDA to retain access to the drug in 17 US states. The company confirmed in a statement on Friday however that for now it continues to make mifepristone available on the market.

Alito has asked that additional briefing material be filed by 18th April.