13 April 2023
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 (FDA) made to ease access.
A panel of three judges on the 5th U.S. Circuit Court of Appeals issued a pause on the initial ruling until the full case can be heard on the merits.
In a decision handed down just before midnight, the court ruled too much time had passed for the anti-abortion groups and doctors who brought the lawsuit to challenge FDA’s initial approval, which occurred in 2000.
But the court said actions taken since 2016 are eligible to be challenged, including; approving mifepristone for use up to 10 weeks into a pregnancy, lifting an in-person dispensing requirement and allowing the drug to be sent through the mail, and the approval of a generic.
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.
DOJ is now likely to appeal to the Supreme Court, and the plaintiffs may too, in order to keep mifepristone off the market completely.
“We are going to continue to fight in the courts, we believe the law is on our side, and we will prevail,” White House press secretary Karine Jean-Pierre told reporters early Thursday during President Biden’s visit to Dublin.
Kacsmaryk’s ruling gave the administration a weeklong window before it went 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 anti-abortion 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, 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 any 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 leave the current mifepristone regime in place for 17 states and D.C. that brought a case separate from the one that Kacsmaryk heard.
The dueling decisions increase the likelihood the dispute ultimately reaches the Supreme Court one way or another, with far-reaching implications.
— Updated at 7:40 a.m.