Lafayette, La. – The United States District Court for the Western District of Louisiana, Lafayette Division today granted GenBioPro’s motion to intervene to defend the company’s generic mifepristone product, which has been proven safe and effective by the U.S. Food and Drug Administration (FDA) for more than 20 years.
“We welcome the court granting our motion to intervene and allowing us to defend our generic mifepristone product,” said GenBioPro CEO Evan Masingill. “We remain concerned about attempts by extremists and special interests to undermine the US Food and Drug Administration’s regulatory authority and will continue to use all legal and regulatory tools to protect mifepristone for patients and providers across the country.”
GenBioPro is represented in the suit by Democracy Forward and Arnold & Porter.
“Today’s decision allows us to continue defending the availability of mifepristone and medication abortion against far–right extremists’ meritless attacks,” said Carrie Flaxman, Senior Legal Advisor at Democracy Forward. “Scientific evidence shows that mifepristone is safe and effective without an in-person visit. Democracy Forward will continue to push back against ideologically extreme organizations and politicians’ efforts to restrict the American people’s access to it.”
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 be 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.
The case is Louisiana et al. v. FDA and the legal team at Democracy Forward includes Carrie Flaxman and Lisa Newman.
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Democracy Forward Foundation is a national legal organization that advances democracy and social progress through litigation, policy, public education, and regulatory engagement. For more information, please visit www.democracyforward.org.
