The Department of Justice (DOJ) is stepping in after a federal judge in Texas overruled two decades of scientific approval by suspending the use of mifepristone, the most common abortion method in the United States. The DOJ is taking a request for a stay pending an appeal directly the Supreme Court.
“The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal,” Attorney General Merrick Garland said in a statement April 13. “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.”
Earlier this month, U.S. District Judge Matthew Kacsmaryk ruled in a lawsuit that mifepristone was unsafe and ordered the suspension of the Food and Drug Administration’s (FDA) approval of the drug. Mifepristone is commonly referred to as the abortion pill and has been safely used in the U.S. and other countries since it was approved for use in the U.S. in 2000. The move was immediately countered with another ruling from a judge in Washington who ordered U.S. authorities not make any changes to access of the abortion drug.
The dueling rulings thrust the legality of mifepristone in question, but hundreds of healthcare leaders and pharmaceutical bigwigs voiced their opposition to Judge Kacsmaryk’s decision in an open letter, arguing the ruling puts all medicines that have gone through the FDA approval process at risk and undermines the pharmaceutical industry’s innovations.
The DOJ’s emergency move also comes after a federal appeals court voted to allow the drug to stay on the market, albeit with restrictions. The appeals court, made up of a three-judge panel, blocked Kacsmaryk’s order late on Wednesday, April 12. However, the judges did roll back changes the FDA made to make mifepristone easier to obtain. Specifically, the order prohibits mail delivery of the drug, which the FDA began allowing in 2021 during the COVID-19 pandemic after health leaders from the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine asked for the change in access.
In addition to now requiring patients to obtain mifepristone from a doctor and undergo examinations in person while taking the medication, the appeals court also cut the timeframe that the abortion pill can be taken, reducing it from 70 days into pregnancy to 49 days. This change is in spite of the FDA’s approval of the drug being used up to 70 days of pregnancy.
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."