U.S. District Judge Matthew Kacsmaryk issued a ruling last Friday ordering the Food and Drug Administration (FDA) to block authorization of mifepristone, a drug commonly used for abortion early in pregnancy.
Kacsmaryk gave the federal government seven days to appeal his ruling, which the Justice Department (DOJ) followed through with on Monday.
The DOJ said the ruling had “upended decades of reliance” by blocking the FDA’s approval, which has been in effect for more than 20 years.
Some Democratic lawmakers, including Sen. Ron Wyden (Ore.) and Rep. Alexandria Ocasio-Cortez (N.Y.), have since called for the FDA to ignore the ruling from Kacsmaryk.
The agency retains discretion over how it enforces laws and regulations and could potentially choose not to impose penalties on healthcare providers who prescribe and distribute mifepristone, which physicians have repeatedly argued has been proven to be safe and effective.
This would not be an unprecedented action on the part of the FDA. The agency issued guidance on enforcement discretion last year during the infant formula shortage crisis, easing import rules in order to boost supply.
Department of Health and Human Services (HHS) officials have so far signaled that the federal government plans to fight this decision in court.
HHS Secretary Xavier Becerra said on Sunday that he believes an appeal will prevail, though he said all options are on the table. Kamara Jones, HHS’s Assistant Secretary for the Public Affairs, said disregarding a binding decision would set a “dangerous precedent.”
Read more at digital-release.thehill.com.
