The high court last week announced it will hear an appeal from the Biden administration which is asking the justices to reverse an appeals court ruling that cut off mail-order mifepristone even in U.S. states with permissive abortion laws.
Alliance Defending Freedom filed a lawsuit in 2022 to overturn mifepristone’s original approval, which dates back two decades, and initially won the case at the federal district court level. A federal appeals court ruled the FDA approval could remain but instead reversed FDA regulations that made access easier, according to an Associated Press story.
"The FDA was entrusted by Congress to be the nation's drug keeper, to determine what is safe and not safe," says Erik Baptist, senior counsel at Alliance Defending Freedom. "When Congress delegated that authority to FDA, it gave specific instructions of how to approve a drug or make changes to a drug regime, and here the FDA failed to follow the Congress and its instructions."
Baptist says FDA has to study the regimen that was approved but ADF argues the FDA, in its 23-year history of this drug, has never actually studied the approved regimen.
Regarding the loosened FDA rules, Baptist says federal law restricts mailing the drugs across state lines but the FDA ignored that law in 2021.
“And that was the last straw,” he tells AFN.
The high court will hear the case next spring, which will be its first abortion-related case since overturning Roe v Wade.