Louisiana – Today, in Louisiana et al. v. FDA, the United States District Court for the Western District of Louisiana, Lafayette Division granted the Department of Justice’s motion to stay the case while the Food and Drug Administration (FDA) conducts its already announced review of mifepristone. The state of Louisiana’s motion for preliminary injunction was denied without prejudice.
With this granted stay, the current state-by-state legal access to mifepristone will not change across the country. The stay was granted over the objections of the state of Louisiana, which sought a preliminary injunction to bar patients nationwide from obtaining mifepristone by mail or from a pharmacy and force them pick up the medication in person at a hospital, clinic, or medical office.
The same judge previously granted a motion to intervene in the case from GenBioPro, the manufacturer of generic mifepristone, which is approved by the U.S. Food and Drug Administration (FDA) as part of a two-drug regimen for the termination of early pregnancy. GenBioPro also opposed the request for preliminary injunction and also asked the court to dismiss the case rather than stay it. Today, GenBioPro’s request to dismiss the case outright was denied without prejudice by the court.
“We fully expect the FDA’s review of mifepristone to reaffirm the more than a quarter century of scientific research, FDA and regulatory review, and real-world use, showing mifepristone to be safe and effective, including when dispensed without an in-person visit,” said GenBioPro CEO Evan Masingill.
GenBioPro is represented in the suit by Democracy Forward Foundation and Arnold & Porter.
“Far-right, ideologically-charged attacks on mifepristone have led to the Trump-Vance administration calling into question its own FDA’s decisionmaking as it pursues its review of mifepristone’s safety,” said Skye Perryman, President and CEO of Democracy Forward. “Although this case should not have been allowed to proceed in the first place, Democracy Forward will hold the FDA accountable to ensure its review is grounded in the extensive, decades-long scientific evidence demonstrating mifepristone’s safety and efficacy.”
Louisiana is represented by the Alliance Defending Freedom, also counsel for the plaintiffs in the original case challenging mifepristone’s availability, Alliance for Hippocratic Medicine v. FDA. In 2024, the U.S. Supreme Court determined that those plaintiffs lacked standing to proceed. Since that time, extremist Attorneys General and now the Alliance Defending Freedom have sought to keep their meritless challenge alive. But just as the original plaintiffs could not proceed with the case, Louisiana’s new challenge also lacks legal merit and should not have been permitted to proceed.
The FDA conducted a rigorous review of mifepristone’s safety and efficacy less than three years ago in 2023. The modifications to the REMS were made to help ease the burden on the health care delivery system and increase access for patients, considering medication abortion is used in two-thirds of U.S. abortions. The changes increased access and flexibility for patients by allowing mifepristone to be distributed by telehealth and through certified pharmacies.
