The Alliance for Hippocratic Medicine has taken action to challenge the FDA’s approval of mifepristone in 2000, seeking support from Louisiana based the U.S. Court of Appeals for the 5th Circuit. They are urging the appeals court to uphold the lower court’s decision to pause the drug’s approval while the important questions raised by their high-profile lawsuit are addressed.
The Alliance for Hippocratic Medicine expressed concerns that the lower court’s order highlights “decades-long agency lawlessness” and presents a troubling situation. They argued in their filing to the appeals court that the public has no interest in maintaining an unlawful approval of the drug by the agency. They further stated that the lower court’s order simply removes mifepristone from the market and the mails, but abortion will still be available in states where it is legally permitted.
The Biden administration has taken action to appeal a decision made by U.S. District Judge Matthew Kacsmaryk that could potentially revoke the FDA approval of a certain drug. Judge Kacsmaryk, who was nominated to the federal bench by former President Donald Trump, had temporarily paused his own ruling for one week.
In its appeal, the Biden administration is seeking to extend the pause on Judge Kacsmaryk’s ruling. The latest filing from the administration is their response to this request.
The government’s legal representatives informed the appeals court on Monday that the FDA has thoroughly evaluated and determined that mifepristone is safe and effective for terminating early pregnancies, a decision that has been upheld by five presidential administrations. The Department emphasized that serious adverse effects are exceptionally rare, comparable to common drugs like ibuprofen, as stated in their earlier filings.
A three-judge panel of the 5th Circuit is expected to make a decision by the end of the week on whether to extend the stay on the federal court’s ruling or let it expire. If the panel chooses to let it expire, the Biden administration is likely to appeal to the Supreme Court.
