TEXAS – Today, February 25, 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, filed a motion to intervene in Missouri et al. v. FDA (formerly known as Alliance for Hippocratic Medicine v. FDA) in the United States District Court for the Northern District of Texas, Amarillo Division. A prior version of this lawsuit was thrown out by the US Supreme Court in a 9-0 decision last year and this second attempt should also be summarily dismissed. The States of Missouri, Kansas, and Idaho have no basis to sue in Texas, rather than in their own states, and also lack standing to challenge the FDA’s approval and regulation of mifepristone. GenBioPro has intervened because its generic approval is under direct attack in the lawsuit and access to mifepristone is essential for millions across the nation. 

“We remain concerned about extremists and special interests’ attempts to undermine the US Food and Drug Administration’s regulatory authority,” said GenBioPro CEO Evan Masingill. “All people have a right to access safe, affordable, evidence-based health care, and GenBioPro remains committed to using all legal and regulatory tools to protect mifepristone for millions of patients and providers across the country.”

GenBioPro was founded on the belief that all people – regardless of income, race, or geography – have a right to reproductive health care, including access to medical abortion. Consistent with that commitment, GenBioPro is promptly seeking to intervene in this litigation and lead the charge in defending the FDA’s 2019 approval of generic mifepristone. 

GenBioPro is represented in the suit by a team of lawyers from the Democracy Forward Foundation and Arnold & Porter. 

“Even after the US Supreme Court ruled last year that the anti-science extremists bringing this case lacked standing, ideologically-driven far-right state attorneys general are continuing to weaponize our courts to try to push their agenda,” said Skye Perryman, President and CEO of Democracy Forward, who is also serving as counsel for the company. “Despite the overwhelming majority of Americans – including constituents of these attorneys general – supporting the legal right to abortion, these politicians remain determined to severely restrict access to a critical drug that women across America depend on. Their baseless attacks not only jeopardize the availability of mifepristone, but also threaten the integrity of our nation’s drug regulation system.” 

“This case should be dismissed outright on procedural grounds and, at a minimum, it cannot proceed in Texas,” said Daphne O’Connor of Arnold & Porter, who represents GenBioPro. “The lawsuit itself is also meritless because FDA regulates generic mifepristone based on decades of experience and extensive scientific evidence and there is no basis for a court to second-guess FDA’s reasoned decision-making.”

For background, following the US Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization, despite the FDA’s approval of mifepristone’s use and safety for over twenty years, in April 2023 a federal district court in Texas issued a decision in Alliance for Hippocratic Medicine v. FDA attempting to block the long-standing approval. When the case was later appealed to the Fifth Circuit Court of Appeals and then to the US Supreme Court, GenBioPro filed an amicus brief urging the US Supreme Court to reverse the Fifth Circuit’s ruling that would compel the FDA to reinstate conditions on the use of mifepristone that existed before 2016. In June 2024, the US Supreme Court ruled the anti-abortion health care providers bringing the challenge did not have standing to bring the case. 

Since the US Supreme Court’s ruling last year, the intervening States of Missouri, Kansas, and Idaho were permitted to file an amended complaint by the district court, which for the first time directly challenges GenBioPro’s approval for generic mifepristone. The Amended Complaint also contends that the court should restore the conditions of mifepristone’s use that existed before 2016, including requiring a medically unnecessary in-person visit for a medication abortion, revoking prescribing authority from health care providers who otherwise prescribe medications, and preventing pharmacies from dispensing the product. GenBioPro joins the existing Defendants in arguing the Amended Complaint should be dismissed for several reasons, including that the case should not proceed in the Northern District of Texas.  

GenBioPro received FDA approval to market the first generic version of mifepristone in 2019. 

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About GenBioPro

GenBioPro, Inc., is a pharmaceutical company working towards a world in which access to safe, affordable, reproductive health care – including medication abortion – is within reach for everyone. The company promotes science and evidence, and access to high-quality health care for all.

For more information about GenBioPro, please visit the company’s website at www.genbiopro.com or call at 1-800-MIFE-INFO.

About Democracy Forward 

Democracy Forward is a national legal organization that is dedicated to the advancement of democracy and social progress. Democracy Forward, along with co-counsel, represents GenBioPro, the manufacturer of generic mifepristone in a lawsuit to reverse West Virginia’s restrictions that limit access to the medication.