A federal appeals court late Wednesday night ruled that the common abortion pill mifepristone can remain on the market, but rolled back a series of recent changes the Food and Drug Administration made to ease access.
The Department of Justice (DOJ) had asked the 5th U.S. Circuit Court of Appeals to stay last week’s ruling from Texas District Judge Matthew Kacsmaryk during the appeals process.
Kacsmaryk’s ruling gave the administration a weeklong window to appeal before it would into effect. The administration asked the 5th Circuit to extend that pause, and to do so by Thursday at noon, “to enable the government to seek relief in the Supreme Court if necessary.”
The antiabortion group challenging the approval could also try to seek relief at the Supreme Court to keep mifepristone off the market during the appeal.
In the decision announced last Friday, Kacsmaryk ruled the agency’s approval process was improperly rushed, and resulted in an unsafe drug regimen getting on the market.
Kacsmaryk said that the FDA violated federal standards when it first approved mifepristone 23 years ago.
In its briefing in support of the emergency stay that would overturn the judge’s pause, the Justice Department argued there was no “basis in administrative law for the district court’s unprecedented overriding of FDA’s considered scientific judgment.”
The Justice Department said Kacsmaryk’s ruling ignored decades of established science. Mifepristone was first approved by the FDA in 2000 and has been proven safe and effective.
Drug industry experts, current and former administration officials and abortion rights advocates have been sounding the alarm that the ruling in favor of anti-abortion groups would have far-reaching consequences for FDA’s authority.
If the decision is upheld, it could open the door to any third party to challenge other medication or treatment that they disagree with, including vaccines for children, AIDS drugs, birth control or hormone therapy.
“The district court purported to be acting in a restrained manner; but there is nothing modest about upending the decades-long status quo by blocking access nationwide to a safe and effective drug,” DOJ wrote.
“The district court’s order would impair the interests of women across the country, supplant the judgments of every State, and arrogate to itself the power that Congress entrusted to FDA to evaluate drug safety.”
Meanwhile, a judge in Washington state has ordered the FDA to keep the current mifepristone regime in place for 17 states and Washington, D.C., which was a separate case from the one that came before Kacsmaryk.
The dueling decisions increase the likelihood the dispute ultimately reaches the Supreme Court one way or another, with far-reaching implications.