Ruling says tablets containing mifepristone can remain available at least temporarily but restrictions are tightened
A US appeals court has ruled that abortion pills containing the drug mifepristone should remain available at least temporarily but has allowed tighter restrictions on how patients access the drug. The ruling by the US Court of Appeals for the Fifth Circuit issued late on Wednesday granted an emergency request by the Biden administration to put on hold a Texas court ruling last week overturning regulators’ approval of mifepristone more than two decades ago. A three-judge panel said the stay would remain in place until a full appeal of the Texas ruling 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 decided not to block a portion of the Texas court’s ruling that effectively reinstates restrictions on the dispensing of mifepristone that have been progressively eased by the FDA since 2016. The court argued 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. The appeals court order follows 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, which if upheld would amount to a nationwide ban on mifepristone. Kacsmaryk, who was appointed by former president Donald Trump, ordered that a preliminary injunction would be placed on mifepristone from this Friday. 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 the drug 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.”
Source: Financial Times