More than 260 congressional Democrats called on the Supreme Court to reverse two lower court rulings regarding a widely used abortion pill, saying the opinions threaten the congressionally mandated drug approval process.
In a friend-of-the-court brief, the lawmakers argued that Congress designated the Food and Drug Administration (FDA) as the expert federal agency with authority to review and approve drugs. But the case involving mifepristone threatens that authority, they said.
“Decades after FDA’s initial approval—yet somehow in an emergency posture—the district court and the Fifth Circuit intruded into FDA’s drug approval process, casting a shadow of uncertainty over its decisions,” the lawmakers wrote. “The specter of precipitous judicial meddling therefore threatens access to life-improving and lifesaving drugs."
At issue in the case are regulatory actions the FDA took in 2016 and 2021 that broadened access to mifepristone, including extending the time frame for mifepristone use during the early stages of pregnancy and removing in-person dispensing requirements.
If the justices don’t reverse the opinion of a federal appeals court, it would “invite federal courts to substitute their judgment for the expert conclusions of FDA’s scientists,” the lawmakers wrote.
According to the lawmakers, the rulings from the district court and federal appeals court “second-guessed FDA’s expert determinations with cherry-picked anecdotes and studies.”
The lawsuit was brought by a group of anti-abortion physicians backed by a right-wing legal group. A federal district court in Texas sided with the doctors and invalidated the FDA's 2000 approval of mifepristone as well as more recent efforts by the agency to make the pill easier to obtain.
But the U.S. Court of Appeals for the 5th Circuit narrowed the decision, leaving the FDA's approval of the drug in place but finding the agency likely acted unlawfully when it loosened the rules. The Biden administration appealed that ruling to the Supreme Court.
The justices are set to hear arguments on March 26. While the lower court rulings would severely limit the accessibility of mifepristone, access to the pill remains unchanged for now in the states where abortion isn’t banned until the Supreme Court renders a final decision, which is expected by the end of June.
“If the Supreme Court affirms the Fifth Circuit’s decision ... it would be effectively rolling back the clock and overriding FDA’s robust scientific approvals process—with immediate and sweeping consequences in every state on the ability of patients to access mifepristone for safe abortion care and miscarriage management,” the lawmakers wrote.
The brief was signed by 50 Senate Democrats and independents, and 213 members of the House.
0 Comments