Biden administration asks US Supreme Court to block abortion pill ruling

The Biden administration has asked the US Supreme Court to intervene and allow abortion pills to remain available while litigation challenging their regulatory approval proceeds.

Merrick Garland, US attorney-general, said on Thursday that the government strongly disagreed with a late-night ruling on Wednesday from the US Court of Appeals for the Fifth Circuit that preserved access to pills containing the drug mifepristone while temporarily imposing some restrictions on them.

“We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care,” Garland said in a statement.  

The appeals court order followed frantic legal efforts this week by the Biden administration and the pharmaceutical industry to challenge a ruling last week by Texas federal judge Matthew Kacsmaryk that overturned regulators’ approval of mifepristone more than two decades ago, which if upheld would amount to a nationwide ban on the drug.

Kacsmaryk, who was appointed by former president Donald Trump, ordered that a preliminary injunction would be placed on mifepristone from Friday.

The Fifth Circuit subsequently granted an emergency request by the Biden administration to put that ruling on hold until a full appeal could be heard, noting in its judgment that the statute of limitations may bar the plaintiffs’ challenge to the US Food and Drug Administration’s approval of mifepristone in 2000.

However, the appeals court declined to block a portion of the Texas court’s ruling that in effect reinstated restrictions on the dispensing of mifepristone that have been progressively eased by the FDA since 2016.

The court said it was not too late for anti-abortion groups to challenge these regulatory decisions, as the statute of limitations had not passed. The restrictions include blocking patients from receiving the drugs by mail and requiring that abortion pills can only be prescribed by doctors.

Legal experts said the Texas court’s order was the most consequential legal ruling handed down in the field of reproductive rights since the repeal of Roe vs Wade by the Supreme Court last year.

Abortion pills containing the drug mifepristone account for more than half of all abortions in the US.    

The Texas ruling is a result of a November filing by a collection of anti-abortion groups that alleged the FDA did not properly approve mifepristone for terminating pregnancies and had not considered its safety when used by girls under the age of 18.

The FDA, most large healthcare associations and the pharmaceutical industry have strongly criticised the ruling by Kacsmaryk, arguing that mifepristone has been safely used to terminate pregnancies for more than two decades.

This week, more than 400 executives in the pharmaceutical industry published an open letter warning that the judgment would diminish the authority of government agencies and put the industry at risk.

“Judicial activism will not stop here,” they wrote. “If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.”