New Orleans – Today, in Louisiana et al. v. FDA, the United States Court of Appeals for the Fifth Circuit reinstated the outdated and medically unnecessary requirement that mifepristone be dispensed only in-person at a clinic, which will block patients’ access nationwide to medication abortion via mail or pharmacies.
Although the case has been brought only by the state of Louisiana, if this ruling is allowed to stand, everyone in America will lose access to mifepristone by mail or from a pharmacy. Women nationwide will be forced to navigate unnecessary barriers in order to pick up the medication in person at a hospital, clinic, or medical office – including in states where abortion remains legal.
This ruling comes despite the United States District Court for the Western District of Louisiana, Lafayette Division last month denying the same request from the state of Louisiana and their attorneys from the Alliance Defending Freedom while the Food and Drug Administration (FDA) conducts its already announced review of mifepristone.
“We are alarmed by this court’s decision to ignore the FDA’s rigorous science and decades of safe use of mifepristone in a case pursued by extremist abortion opponents. We are reviewing the court’s order in detail,” said GenBioPro CEO Evan Masingill. “We remain committed to taking any actions necessary to make mifepristone available and accessible to as many people as possible in the country, regardless of anti-abortion special interests trying to undermine patients’ access. As we have said time and time again, GenBioPro firmly believes that all people, regardless of income, gender, race, or geography, have a right to access evidence-based health care and safe and effective medicines, and that includes mifepristone.”
GenBioPro is represented in the suit by Democracy Forward Foundation and Arnold & Porter.
“The Fifth Circuit’s decision today is alarming, and will have severe consequences for women across the country. This is the anti-abortion extremists’ playbook in action once again: weaponize the courts to serve their political interests, ignore decades of scientific evidence proving mifepristone’s safety, and put women directly in harm’s way,” said Skye Perryman, President and CEO of Democracy Forward. “This decision needlessly blocks millions from critical healthcare, discriminating in particular against those who live in rural and other areas where healthcare is inaccessible. Even as this assault defies the will of the overwhelming majority of the American public, these ideologically extreme politicians and organizations are determined to impose a narrow, autocratic agenda – no matter the cost. Our fight is not over.”
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 state Attorneys General and the Alliance Defending Freedom have sought to keep their meritless challenge alive. But just as the original plaintiffs could not proceed with the case, GenBioPro argues that Louisiana’s new challenge also lacks legal merit and should not be permitted to proceed.
GenBioPro, the manufacturer of generic mifepristone, which is approved by the FDA as part of a two-drug regimen for the termination of early pregnancy, has intervened in the case and opposed the request for preliminary injunction in the district court and in the Fifth Circuit. GenBioPro also asked the district court to dismiss the case entirely, but that request was denied without prejudice pending the FDAs ongoing review of mifepristone’s safety.
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.
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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.
